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Biotechnology | Encyclopedia.com

Thursday, February 4th, 2021

Biotechnology is a set of techniques by which human beings modify living things or use them as tools. In its modern form, biotechnology uses the techniques of molecular biology to understand and manipulate the basic building blocks of living things. The earliest biotechnology, however, was the selective breeding of plants and animals to improve their food value. This was followed in time by the use of yeast to make bread, wine, and beer. These early forms of biotechnology began about ten thousand years ago and lie at the basis of human cultural evolution from small bands of hunter-gatherers to large, settled communities, cities, and nations, giving rise, in turn, to writing and other technologies. It is doubtful that, at the outset, the first biotechnologists understood the effects of their actions, and so the reason for their persistence in pursuing, for example, selective breeding over the hundreds of generations necessary to show much advantage in food value, remains something of a mystery.

The world's historic religions emerged within the context of agriculture and primitive biotechnology, and as one might expect they are at home in that context, for instance through their affirmation of agricultural festivals. In addition, Christianity took the view that nature itself has a history, according to which, nature originally was a perfectly ordered garden, but as a result of human refusal to live within limits, nature was cursed or disordered by its creator. The curse makes nature at once historic, disordered, both friendly and hostile to human life, and open to improvement through human work. These effects fall especially on human agriculture and childbirth, both of which are focal areas of biotechnology.

By the time of Charles Darwin (18091882), plant and animal breeders were deliberate and highly successful in applying techniques of selective breeding to achieve specific, intended results. Darwin's theory of evolution is built in part on his observation of the ability of animal breeders to modify species. The work of human breeders helped Darwin see that species are variable, dynamic, and subject to change. Inspired by the success of intentional selective breeding, Darwin proposed his theory of natural selection, by which nature unintentionally acts something like a human breeder. Nature, however, uses environmental selection, which favors certain individuals over others in breeding. The theory of natural selection, of course, led to a profound shift in human consciousness about the fluidity of life, which in turn fueled modern biotechnology and its view that life may be improved. While Christianity struggled with other implications of Darwinism, it did not object to the prospect that human beings can modify nature, perhaps even human nature.

In the twentieth century, as biologists refined Darwin's proposal and explored its relationship to genetics, plant breeders such as Luther Burbank (18491926) and Norman Borlaug (1914) took selective breeding to new levels of success, significantly increasing the quality and quantity of basic food crops. But it was the late twentieth-century breakthroughs in molecular biology and genetic engineering that established the technological basis for modern biotechnology. The discovery that units of hereditary information, or genes, reside in cells in a long molecule called deoxyribonucleic acid (or DNA) led to an understanding of the structure of DNA and the technology to manipulate it. Biotechnology is no longer limited to the genes found in nature or to those that could be moved within a species by breeding. Bioengineers can move genes from one species to another, from bacteria to human beings, and they can modify them within organisms.

The discovery in 1953 of the structure of DNA by Francis Crick (b. 1916) and James Watson (b. 1928) is but one key step in the story of molecular biology. Within two decades, this discovery opened the pathway to the knowledge of the socalled genetic alphabet or code of chemical bases that carry genetic information, an understanding of the relationship between that code and the proteins that result from it, and the ability to modify these structures and processes (genetic engineering). The decade of the 1980s saw the first transgenic mammals, which are mammals engineered to carry a gene from other species and to transmit it to their offspring, as well as important advances in the ability to multiply copies of DNA (polymerase chain reaction or PCR). The Human Genome Project, an international effort begun around 1990 to detail the entire DNA information contained in human cells, sparked the development of bioinfomatics, the use of powerful computers to acquire, store, share, and sort genetic information. As a result, not only is a standard human DNA sequence fully known (published in February 2001), but it is now possible to determine the detailed code in any DNA strand quickly and cheaply, a development likely to have wide applications in medicine and beyond.

Biotechnology is also dependent upon embryology and reproductive technology, a set of techniques by which animal reproduction is assisted or modified. These techniques were developed largely for agricultural purposes and include artificial insemination, in vitro fertilization, and other ways of manipulating embryos or the gametes that produce them. In 1978, the first in vitro human being was born, and new techniques are being added to what reproductive clinics can do to help women achieve pregnancy. These developments have been opposed by many Orthodox Christian and Roman Catholic theologians, by the Vatican, and by some Protestants, notably Paul Ramsey. Other faith traditions have generally accepted these technologies. In addition, some feminist scholars have criticized reproductive medicine as meeting the desires of men at the expense of women and their health.

Reproductive medicine, however it may be assessed on its own merits, does raise new concerns when it is joined with other forms of biotechnology, such as genetic testing and genetic engineering. In the 1990s, in vitro fertilization was joined with genetic testing, allowing physicians to work with couples at risk for a genetic disease by offering them the option of conceiving multiple embryos, screening them for disease before implantation, and implanting only those that were not likely to develop the disease. This technique, known as preimplantation diagnosis, is accepted as helpful by many Muslim, Jewish, and Protestant theologians, but is rejected by Orthodox Christians and in official Catholic statements. The ground for this objection is that the human embryo must be shown the respect due human life, all the more so because it is weak and vulnerable. It is permissible to treat the embryo as a patient, but not to harm it or discard it in order to treat infertility or to benefit another. The usual counterargument is to reject the view that the embryo should be respected as a human life or a person.

Developments in cloning and in the science and technology of stem cells offer additional tools for biotechnology. In popular understanding, cloning is usually seen as a technique of reproduction, and of course it does have that potential. The birth of Dolly, the cloned sheep, announced in 1997, was a surprising achievement that suggests that any mammal, including human beings, can be created from a cell taken from a previously existing individual. Many who accept reproductive technology generally, including such techniques as in vitro fertilization, found themselves opposing human reproductive cloning, but they are not sure how to distinguish between the two in religiously or morally compelling ways. With few exceptions, however, religious institutions and leaders from all faith traditions have opposed human reproductive cloning, if only because the issues of safety seem insurmountable for the foreseeable future. At the same time, almost no one has addressed the religious or moral implications of the use of reproductive cloning for mammals other than human beings, although it has been suggested that it would not be wise or appropriate to use the technique to produce large herds of livestock for food because of the risk of a pathogen destroying the entire herd.

The technique used to create Dollythe transfer of the nuclear DNA from an adult cell to an egg, thereby creating an embryo and starting it through its own developmental processcan serve purposes other than reproduction, and it is these other uses that are especially interesting to biotechnology. Of particular interest is the joining of the nuclear transfer technique with the use of embryonic stem cells to treat human disease. In 1998, researchers announced success in deriving human embryonic stem cells from donated embryos. These cells show promise for treating many diseases. Once derived, they seem to be capable of being cultured indefinitely, dividing and doubling in number about every thirty hours. As of 2002, researchers have some confidence that these cells can be implanted in the human body at the site of disease or injury, where they can proliferate and develop further, and thereby take up the function of cells that were destroyed or impaired.

Stem cells, of course, can be derived from sources other than the embryo, and research is underway to discover the promise of stem cells derived from alternative sources. There are two advantages in using these other sources. First, no embryos are destroyed in deriving these cells. For anyone who sets a high standard of protection for the human embryo, the destruction of the embryo calls into question the morality of any use of embryonic stem cells. Second, the use of stem cells from sources other than an embryo may mean that in time, medical researchers will learn how to derive healing cells from the patient's own body. The advantage here is that these cells, when implanted, will not be rejected by the patient's immune system. Embryonic stem cells, which may have advantages in terms of their developmental plasticity, are decidedly problematic because of the immune response.

One way to eliminate the immune response is to use nuclear transfer to create an embryo for the patient, harvesting stem cells from that embryo (thereby destroying it) and implanting these cells in the patient. Because they bear the patient's DNA, they should not be rejected. This approach is medically complicated, however, and involves the morally problematic step of creating an embryo to be destroyed for the benefit of another.

As a result of the developments in the underlying science and technologies, biotechnology is able to modify any form of life in ways that seem to be limited only by the imagination or the market. Biotechnology has produced genetically modified microorganisms for purposes ranging from toxic waste clean-up to the production of medicine. For example, by inserting a human gene into a bacterium that is grown in bulk, biotechnology is able to create a living factory of organisms that have been engineered to make a specific human protein. Such technologies may also be used to enhance the virulence of organisms, to create weapons for bioterrorism, or to look for means of defense against such weapons. Aside from obvious concerns about weapons development, religious institutions and scholars have not objected to these uses of biotechnology, although some Protestant groups question the need for patents, especially when sought for specific genes.

Plants, perhaps the first organisms modified by the earliest biotechnology, remain the subject of intense efforts. Around the year 2000, major advances were made in plant genome research, leading to the possibility that the full gene system of some plant species can be studied in detail, and the ways in which plants respond to their environment may be understood as never before. Some attention is given to plants for pharmaceutical purposes, but the primary interest of biotechnology in plants is to improve their value and efficiency as sources of food. For instance, attempts have been made to increase the protein value of plants like rice. The dependence of farm plants on fertilizer and pesticides may also be reduced using biotechnology to engineer plants that, for instance, are resistant to certain insects.

In the 1990s, the expanding use of genetically modified plants in agriculture was met with growing concerns about their effects on health and on the environment. Adding proteins to plants by altering their genes might cause health problems for at least some who consume the plants, perhaps through rare allergic reactions. Genes that produce proteins harmful to some insects may cause harm to other organisms, and they might even jump from the modified farm plant to wild plants growing nearby. Furthermore, some believe that consumers have a right to avoid food that is altered by modern biotechnology, and so strict segregation and labeling must be required. Deeply held values about food and, to some extent, its religious significance underlie many of these concerns. In Europe and the United Kingdom, where public opposition to genetically modified food has been strong, some churches have objected to excessive reliance upon biotechnology in food production and have supported the right of consumers to choose, while at the same time recognizing that biotechnology can increase the amount and the value of food available to the world's neediest people.

Animals are also modified by biotechnology, and this raises additional concerns for animal welfare. Usually the purpose of the modification is related to human health. Biotechnologists may, for example, create animals that produce pharmaceuticals that are expressed, for instance, in milk, or they may create animal research models that mimic human disease. These modifications usually involve a change in the animal germlinethat is, they are transmissible to future generations and they affect every cell in the body. Such animals may be patented, at least in some countries. All this raises concern about what some see as the commodification of life, the creation of unnecessary suffering for the animals, and a reductionistic attitude toward nature that sees animals as nothing but raw materials that may be reshaped according to human interest.

It is the human applications of biotechnology, however, that elicit the most thorough and intense religious responses. As of 2002, genetic technologies are used to screen for a wide range of genetic conditions, but treatments for these diseases are slow to develop. Screening and testing of pregnancies, newborns, and adults have become widespread in medicine, and the resulting knowledge is used to plan for and sometimes prevent the development of disease, or to terminate a pregnancy in order to prevent the birth of an infant with foreseeable health problems. Some religious bodies, especially Roman Catholic and Orthodox Christian, vigorously criticize this use of genetic testing. One particular use of prenatal testingto identify the sex of the unborn and to abort femalesis thought to be widespread in cultures that put a high priority on having sons, even though it is universally criticized. It is believed that the uses of testing will grow, while the technologies to treat disease will lag behind.

Attempts at treatment lie along two general pathways: pharmaceuticals and gene therapy. Biotechnology offers new insight into the fundamental processes of disease, either by the creation of animal models or by insight into the functions of human cells. With this understanding, researchers are able to design pharmaceutical products with precise knowledge of their molecular and cellular effects, with greater awareness of which patients will benefit, and with fewer side effects. This is leading to a revolution in pharmaceutical products and is proving to be effective in treating a range of diseases, including cancer, but at rapidly increasing costs and amidst growing concerns about access to these benefits, especially in the poorest nations.

Gene therapy, begun in human beings in 1990, tries to treat disease by modifying the genes that affect its development. Originally the idea was to treat the classic genetic diseases, such as Tay Sachs or cystic fibrosis, and it is expected that in time this technique will offer some help in treating these diseases. But gene therapy will probably find far wider use in treating other diseases not usually seen as genetic because researchers have learned how genes play a role in the body's response to every disease. Modifying this response may be a pathway to novel therapies, by which the body treats itself from the molecular level. For instance, it has been shown that modified genes can trigger the regeneration of blood vessels around the heart. In time these approaches will probably be joined with stem cell techniques and with other cell technologies, giving medicine a range of new methods for modifying the body in order to regenerate cells and tissues.

Religious opinion has generally supported gene therapy, seeing it as essentially an extension of traditional therapies. At the same time, both religious scholars and bioethicists have begun to debate the prospect that these technologies will be used not just to treat disease but to modify traits, such as athletic or mental ability, that have nothing to do with disease, perhaps to enhance these traits for competitive reasons. Many accept the idea of therapy but reject enhancement, believing that there is a significant difference between the two goals. Many scholars, however, are skeptical about whether an unambiguous distinction can be drawn, much less enforced, between therapy and enhancement. Starting down the pathway of gene therapy may mean that human genetic enhancement is likely to follow. This prospect raises religious concerns that people who can afford to do so will acquire genetic advantages that will lead to further privilege, or that people will use these technologies to accommodate rather than challenge social prejudices.

It is also expected that these techniques will be joined with reproductive technologies, opening the prospect that future generations of humans can be modified. The prospect of such germline modification is greeted with fear and opposition by many, usually for reasons that suggest religious themes. In Europe, germline modification is generally rejected as a violation of the human rights of future generations, specifically the right to be born with a genome unaffected by technology. In the United States, the opposition is less adamant but deeply apprehensive about issues of safety and about the long-term societal impact of what are popularly called "designer babies." Religious bodies have supported these concerns and have called either for total opposition or careful deliberation.

How far biotechnology can go is limited by the complexities of life processes, in particular in the subtleties of interaction between DNA and the environment. Biotechnology itself helps researchers discover these subtleties, and as much as biotechnology depends upon the sciences of biology and genetics, it must be noted that the influence between technology and science is reciprocal. The Human Genome Project, for instance, opened important new questions about human evolution and about how DNA results in proteins. Knowledge of the genomes of various species reveals that the relationship between human beings and distant species, such as single-celled or relatively simple organisms, turns out to be surprisingly close, suggesting that evolution conserves genes as species diverge.

Perhaps even more surprising is the way in which the Project has challenged the standard view in modern genetics of the tight relationship between each gene and its protein, the so-called dogma of one gene, one protein. It turns out that human beings have about one hundred thousand proteins but only about thirty-three thousand genes, and that genes are more elusive and dynamic than once thought. It appears that DNA sequences from various chromosomes assemble to become the functional gene, the complete template necessary to specify the protein, and that these various sequences can assemble in more than one way, leading to more than one protein. Such dynamic complexity allows some thirty-three thousand DNA coding sequences to function as the templates for one hundred thousand proteins. But this complexity, in view of the limited understanding of the processes that define it, means that the ability to modify DNA sequences may have limited success and unpredictable consequences, which should lower confidence in genetic engineering, especially when applied to human beings.

Biotechnology is further limited by financial factors. Most biotechnology is pursued within a commercial context, and the prospect of near-term financial return must be present to support research. Biotechnology depends upon access to capital and upon legal protection for intellectual property, such as the controversial policy of granting patent protection on DNA sequences or genes and on genetically modified organisms, including mammals. This financial dependence is itself a matter of controversy, giving rise to the fear that life itself is becoming a mere commodity or that the only values are those of the market.

There is no reason, however, to think that biotechnology has reached the limits of its powers. On the contrary, biotechnology is growing not just in the scope of its applications but in the range and power of its techniques. Biotechnology's access to the whole genomes of human beings and other species means that the dynamic action and interaction of the entire set of genes can be monitored. In one sense, the completion of full genomes ushers in what some have called post-genomic biotechnology, characterized by a new vantage point of a systematic overview of the cell and the organism. This is proving valuable, for instance, in opening new understandings of cancer as a series of mutation events within a set of cells in the body. Attention is turning, however, from the study of genes to the study of proteins, which are more numerous than genes but also more dynamic, coming quickly into and out of existence in the trillions of cells of the human body according to precise temporal and spatial signals. Most human proteins are created only in a small percentage of cells, during a limited period of human development, and only in precisely regulated quantities. Studying this full set of proteins, in all its functional dynamism, is a daunting task requiring technologies that do not exist at the beginning of the twenty-first century. The systematic study of proteins, called proteomics, may in fact become a new international project for biology, leading in time to a profound expansion of the powers of biotechnology.

In time, researchers will develop powerful new methods for modifying DNA, probably with far higher precision and effectiveness than current techniques allow, and perhaps with the ability to transfer large amounts of DNA into living cells and organisms. Computer power, which is essential to undertakings like the Human Genome Project and to their application, continues to grow, along with developments such as the so-called gene chip, using DNA as an integrated part of the computing device. Advances in engineering at the very small scale, known as nanotechnology (from nanometer, a billionth of a meter), suggest that molecular scale devices may someday be used to modify biological functions at the molecular level. For instance, nanotechnology devices in quantity may be inserted into the human body to enter cells, where they might modify DNA or other molecules. In another area of research, scientists are exploring the possibility that DNA itself may be used as a computer or a data storage device. DNA is capable of storing information more efficiently than current storage media, and it may be possible to exploit this capacity.

It is impossible to predict when new techniques will be developed or what powers they will bring. It is clear, however, that new techniques will be found and that they will converge in their effectiveness to modify life. Precisely designed pharmaceutical products will be available to treat nearly every disease, often by interrupting them at the molecular level and doing so in ways that match the specific needs of the patient. Stem cells, whether derived from embryos or from patients themselves, will probably be used to regenerate nearly any tissue or cell in the body, perhaps even portions of organs, including the brain. The genes in patients' bodies will be modified, either to correct a genetic anomaly that underlies a disease or to trigger a special response in specific cells to treat a disease or injury. It is more difficult to foresee the full extent of the long-term consequences of biotechnology on nonhuman species, on the ecosystem, on colonies of life beyond Earth, and on the human species itself; estimates vary in the extreme. Some suggest that through these means, human beings will engineer their own biological enhancements, perhaps becoming two or more species.

The prospect of these transformations has evoked various religious responses, and scholars from many traditions have been divided in their assessments. Those who support and endorse biotechnology stress religious duties to heal the sick and feed the hungry. Most hold the view that nature is to be improved, perhaps within limits, and that human beings are authorized to modify the processes of life. Some suggest that creation is not static but progressive, and that human beings are co-creators with God in the achievement of its full promise.

Others believe biotechnology will pervert nature and undermine human existence and its moral basis. They argue, for instance, that genetic modifications of offspring will damage the relationship between parents and children by reducing children to objects, products of technology, and limit their freedom to grow into persons in relationship with others. Some warn that saying yes to biotechnology now will make it impossible to say no in the future. Still others suggest that the point is not to try to stop biotechnology but to learn to live humanely with its powers, and as much as possible to steer it away from selfish or excessive uses and toward compassionate and just ends.

See also Cloning; Darwin, Charles; DNA; Evolution; Eugenics; Gene Patenting; Gene Therapy; Genetically Modified Organisms; Genetic Engineering; Genetics; Genetic Testing; Human Genome Project; In Vitro Fertilization; Reproductive Technology; Stem Cell Research

american association for the advancement of science. "human inheritable genetic modifications: assessing scientific, ethical, religious, and policy issues." washington, d.c.: aaas, 2000

bruce, donald, and bruce, ann, eds. engineering genesis: the ethics of genetic engineering in non-human species. london: earthscan publications, 1998

chapman, audrey r. unprecedented choices: religious ethics at the frontiers of genetic science. minneapolis, minn.: fortress press, 1999

cole-turner, ronald. the new genesis: theology and the genetic revolution. louisville, ky.: westminster and john knox press, 1993.

cole-turner, ronald. beyond cloning: religion and the remaking of humanity. harrisburg, pa.: trinity press international, 2001.

dorff, elliot n. matters of life and death: a jewish approach to modern medical ethics. philadelphia, pa.: jewish publication society, 1998

dorff, elliot n. "jewish views on technology in health care." in claiming power over life: religion and biotechnology policy, ed. mark j. hanson. washington, d.c.: georgetown university press, 2001.

evans, john h. playing god? human genetic engineering and the rationalization of public bioethical debate. chicago: university of chicago press, 2002.

genome sequencing consortium. "initial sequencing and analysis of the human genome." nature 409 (2001): 860921.

kilner, john f.; pentz, rebecca d.; and young, frank e., eds. genetic ethics: do the ends justify the genes? grand rapids, mich.: eerdmans, 1997.

national council of churches, panel on bioethical concerns. genetic engineering: social and ethical consequences. new york: pilgrim press, 1984.

peacocke, arthur r. god and the new biology. san francisco: harper, 1986.

peters, ted. playing god? genetic determinism and human freedom. new york: routledge, 1997.

peters, ted, ed. genetics: issues of social justice. cleveland, ohio: pilgrim press, 1998.

peterson, james c. genetic turning points: the ethics of human genetic intervention. grand rapids, mich.: eerdmans, 2001.

rahner, karl. "the problem of genetic manipulation." in theological investigations, vol. 9, trans. g. harrison. new york: seabury, 1966.

rahner, karl. "the experiment with man: theological observations on man's self-manipulation." in theological investigations, vol. 9, trans. g. harrison. new york: seabury, 1966.

ramsey, paul. fabricated man: the ethics of genetic control. new haven, conn.: yale university press, 1970.

shinn, roger lincoln. the new genetics: challenges for science, faith and politics. london and wakefield, r.i.: moyer bell, 1996.

venter, j. craig, et. al. "the sequence of the human genome." science 291 (2001): 13041351.

willer, roger a., ed. genetic testing and screening: critical engagement at the intersection of faith and science. minneapolis, minn.: kirk house, 1998.

world council of churches, church and society. manipulating life: ethical issues in genetic engineering. geneva: world council of churches, 1982.

world council of churches, church and society. biotechnology: its challenges to the churches and the world. geneva: world council of churches, 1989.

ronald cole-turner

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PDS Biotechnology Moves Forward With Full Enrollment In PDS0101 Trial In HPV-Associated Cancers, Shares Retreat – Yahoo Finance

Thursday, February 4th, 2021

TipRanks

Lets talk about risk and the big picture. Its an appropriate time, as the big risk presented by the COVID-19 pandemic is finally receding thanks to the ongoing vaccination program. COVID is leaving behind an economy that was forced into shutdown one year ago while in the midst of a great expansion, boosted by the deregulation policies. While the new Biden Administration is busy reversing many Trump policies, at least for now the economy is rebounding. And this brings us to risk. A time of economic growth and rebound is a forgiving time to move toward risk investments, as general economic growth tends to lift everything. Two strategists from JPMorgan have recently chimed in, promoting the view that the markets fundamentals are still sound, and that small- to mid-cap sector is going to keep rising. First, on the general conditions, quant strategist Dubravko Lakos-Bujas wrote, Although the recent technical selloff and short squeeze is receiving a lot of attention, we believe the positive macro setup, improving fundamentals and COVID-19 outlook, strength of the US consumer, as well as the reflation theme remain the bigger forces at play. Not only should this drive further equity upside, but it remains favorable for continued rotation into economic reopening Building on this, Eduardo Lecubarr, chief of the Small/Mid-Cap Strategy team, sees opportunity for investors now, especially in the smaller value stocks. We stick to our view that 2021 will be a stockpickers paradise with big money-making opportunities if you are willing to go against the grain Many macro indicators did fall in January but SMid-Caps and equities in general continued to edge higher, Lecubarr noted. And if you are prone to look at high-risk, small- to mid-cap stocks, youll find yourself drawn to penny stocks. The risk involved with these plays scares off the faint hearted as very real problems like weak fundamentals or overwhelming headwinds could be masked by the low share prices. So, how should investors approach a potential penny stock investment? By taking a cue from the analyst community. These experts bring in-depth knowledge of the industries they cover and substantial experience to the table. Bearing this in mind, we used TipRanks database to find two compelling penny stocks, according to Wall Street analysts. Both tickers boast a Strong Buy consensus rating and could climb over 200% higher in the year ahead. CNS Pharmaceuticals (CNSP) We will start with CNS Pharmaceuticals, a biotechnology company with a focus on the treatment of glioblastomas, a class of aggressive tumors that attack the braid and spinal cord. These cancers, while rare, are almost always terminal, and CNS is working a new therapy designed to more effectively cross the blood-brain barrier to attack glioblastoma. Berubicin, CNSs flagship drug candidate, is an anthracycline, a potent class of chemotherapy drugs derived from the Streptomyces bacteria strains, and used in the treatment of a wide variety of cancers. Berubicin is the first drug in this class to show promise against glioblastoma cancers. The drug candidate has completed its Phase 1 clinical trial, in which 44% of patients showed a clinical response. This number included one patient who showed a Durable Complete Response, defined as a demonstrated lack of detectable cancer. Following the success of the Phase 1 study, CNS applied for, and received, FDA approval of its Investigational New Drug application. This gives the company the go-ahead to conduct a Phase 2 study on adult patients, an important next step in the development of the drug. CNS plans to start the mid-stage trial in 1Q21. Based on the potential of the companys asset in glioblastoma, and with its share price at $2.22, several analysts believe that now is the time to buy. Among the bulls is Brooklines 5-star analyst Kumaraguru Raja who takes a bullish stance on CNSP shares. Until now, the inability of anthracyclines to cross the blood brain barrier prevented its use for treatment of brain cancers. Berubicin is the first anthracycline to cross the blood-brain barrier in adults and access brain tumors Berubicin has promising clinical data in a Phase 1 trial in recurrent glioblastoma (rGBM) and has Orphan drug designation for treatment of malignant gliomas from the FDA. We model approval of Berubicin for treatment of recurrent glioblastoma in 2025 based on the Phase 2 data with 55% probability of success for approval. We model peak sales of $533 million in 2032, Raja opined. CNS pipeline also includes WP1244 (novel DNA binding agent) that is 500x more potent than daunorubicin in inhibiting tumor cell proliferation is expected to enter the clinic in 2021 In vivo testing in orthotopic models of brain cancer showed high uptake of WP1244 by brain and subsequent antitumor activity, the analyst added. To this end, Raja rates CNSP a Buy, and his $10 price target implies room for a stunning 350% upside potential in the next 12 months. (To watch Rajas track record, click here) What does the rest of the Street have to say? 3 Buys and 1 Hold add up to a Strong Buy consensus rating. Given the $8.33 average price target, shares could climb ~275% in the year ahead. (See CNSP stock analysis on TipRanks) aTyr Pharma (LIFE) The next stock were looking at, aTyr Pharma, has a focus on inflammatory disease. Its leading drug candidate, ATYR1923, is a Neuropilin-2 (NRP2) agonist, working through the receptor proteins expressed by the NRP2 gene. These pathways are important for cardiovascular development and disease, and play a role in the inflammatory lung disease pulmonary sarcoidosis. In December, the company reported that the drug candidate had completed enrollment of 36 patients in a Phase 1b/2a clinical trial, testing the drug in the treatment of pulmonary sarcoidosis. Results of the current study are expected in 3Q21, and will inform further trials of ATYR1923, including against other forms of inflammatory lung disease. On a more immediate note, in early January the company announced top-line results of another Phase 2 clinical involving ATRY1923 this time in the treatment of patients hospitalized with severe respiratory complications from COVID-19. The results were positive, showing that a single dose of ATYR1923 (at 3 mg/kg) resulted in a 5.5-day median recovery time. Overall, of the patients dosed in this manner, 83% saw recovery in less than one week. Covering LIFE for Roth Capital, 5-star analyst Zegbeh Jallah noted, We like the risk profile here, with two shots on goal, and updated data details from the COVID study is expected in the coming months. Also announced recently, is that data from aTyr's Pulmonary Sarcoidosis program, will be reported in 3Q21 the success of either of these studies could result in a doubling or more of the market cap as these opportunities appear to barely be accounted for by investors. In line with his optimistic approach, Jallah gives LIFE shares a Buy rating and his $15 price target suggests an impressive 277% potential upside for the coming year. (To watch Jallahs track record, click here) Other analysts are on the same page. With 2 additional Buy ratings, the word on the Street is that LIFE is a Strong Buy. On top of this, the average price target is $13.33, suggesting robust growth of ~236% from the current price of $3.97. (See LIFE stock analysis on TipRanks) To find good ideas for penny stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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Nano Biotechnology Market 2021, Size, Share, Global Industry Growth, Business Statistics, Top Leaders, Competitive Landscape, Forecast To 2027 KSU |…

Thursday, February 4th, 2021

Nano Biotechnology Market:Global Size, Trends, Competitive, Historical & Forecast Analysis, 2020-2025. Increasing demand of new therapies for various tissues of lungs and cardiac as well as rising organizations investment in research and development for new drugs are some important factors driving the growth of Nano biotechnology market.

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Nano biotechnology is application of nanotechnology which is applied in biological field. The concept nanotechnology means a designed, development and applications of material which functional make up is on a nanometer scale. Technically nanotechnology is developing material or other structured material which is size from 1 to 100 nanometers. And biotechnology means the study of biological subjects including microorganism. Nano biotechnology is intersection of biology and nanotechnology. Nano biotechnology is a study of biological and biochemical applications. Nano biotechnology is used to study the nature of fabricating new Nano devices and elements which exists in living organisms. The use of Nano biotechnology in commercial applications in biomedical field is direction towards development of new techniques in biosciences and drug delivery systems.

The global nano biotechnology is segmented on the basis of applications, therapeutics and by regional basis. Based on application the global Nano biotechnology is segmented as medical research, medical devices, pharmaceuticals and others. On the basis of therapeutics the global Nano biotechnology market is divided as orthopedic therapies, dental therapies, cardiac therapies and others.

The regions covered in global Nano biotechnology report are North America, Europe, Asia-Pacific and Rest of the World. On the basis of country level, Global Nano biotechnology sub divided in U.S., Mexico, Canada, U.K., France, Germany, Italy, China, Japan, India, South East Asia, GCC, Africa, etc.

Nano Biotechnology Companies:

Global Nano biotechnology reports cover prominent players like,

Dabur Pharma

cellix

InanoBio

Marina Biotech

dermaCM

Ablynx

Xantac Bioanalytics

AC Serndip

WaveSense

Nanobiotech Pharma

Celgene

Thermo Fisher Scientific

merck KGaA

Bionano Genomics

Others

New Nano drug candidate kills aggressive breast cancer cells

News: July 20, 2020 The researchers at the University of Arkansas have developed a new Nano drug candidate that kills triple-negative breast cancer cells. Triple-negative breast cancer is one of the most aggressive and fatal types of breast cancer. The research will help clinicians target breast cancer cells directly while avoiding the adverse and toxic side effects of chemotherapy. The American Cancer Society estimated 268,600 new cases of invasive breast cancer in 2019 and 41,760 deaths. Researchers in Beyzavis laboratory focus on developing new targeted photodynamic therapy drugs, as alternative to chemotherapy and significantly fewer side effects.

Global Nano Biotechnology Dynamics

The key factor for growth of global Nano biotechnology is increasing advancements in medical science to improve healthcare practices around the world for better drug delivery system which drives the growth of Nano biotechnology market. The product of Nano biotechnology is under trial but scientist have confident that this trail will give positive result to increase the prevention process, diagnosis and treatment of various diseases. Nano biotechnology is also used in areas like electronics, biomaterial and energy production. The public and private companies are also showing keen interest in Nano biotechnology which gives commercial platform for the product of Nano biotechnology.

More detailed research is required to introduce diverse components of Nano biotechnology in medical applications which restrain the growth of global Nano biotechnology market. The effect of toxicity of Nano material on environment and economy affect the growth of Nano biotechnology market. However the increase in government initiative for research and development in Nano biotechnology will increase opportunities of Nano biotechnology market in future.

The National Nanotechnology Initiatives (NNI) funded approximately USD 170 billion in 2018. Currently there are 60 countries which is member of National Nanotechnology Initiative and conducted program on National Nanotechnology. According to National institute of standard there are 1700 nanotechnology companies worldwide.

Nano BiotechnologyRegional Analysis

North America is dominating the growth nano biotechnology due to increase in investment in research and development projects and implementing flexible policies. The National Nanotechnology Initiatives which was established in 2001 which develop nanotechnology within United States. There is 3729 patent registered in USA on Nanotechnology in 2018. European Union is expected to emerge the growth of share in global Nano biotechnology market. To increase in research and development spending and investment in public and private sectors of Nano biotechnology. The European Union has published the publications on Nano biotechnology.

Asia Pacific is also emerging in the field of nano biotechnology. India has introduced Nano biotechnology based chemotherapy. The Nano biotechnology have introduced polymer free drug for treatment of cardiac disease. The drug name is Sirolimous which shows extreme excellent result which reduces the blockages of in the arteries. China has duplicated research paper and publication about 3592 and 30.479 respectively. The patent on Nano biotechnology of china is 5030 in 2019.

Key Benefits forNano biotechnologyreports

Global Nano biotechnology report covers in depth historical and forecast analysis.

Global Nano biotechnology Market research report provides detail information about Market Introduction, Market Summary, Global market Revenue (Revenue USD), Market Drivers, Market Restraints, Market opportunities, Competitive Analysis, Regional and Country Level.

Global Nano biotechnology report helps to identify opportunities in market place.

Global Nano biotechnology report covers extensive analysis of emerging trends and competitive landscape.

Nano BiotechnologySegmentation

by Application:Medical Devices, Pharmaceuticals, Medical research, Others

by Therapeutics:Cardiac Therapies, Orthopedic Therapies, Dental therapies, Others

Regional & Country AnalysisNorth America, U.S., Mexico, Canada , Europe, UK, France, Germany, Italy , Asia Pacific, China, Japan, India, Southeast Asia, South America, Brazil, Argentina, Columbia, The Middle East and Africa, GCC, Africa, Rest of Middle East and Africa

Continued

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https://www.marketwatch.com/press-release/cell-culture-industry-size-industry-analysis-report-statistics-application-development-price-trends-competitive-market-share-forecast-20212027-2021-02-03?tesla=y

https://www.marketwatch.com/press-release/europe-construction-equipment-market-by-growth-trends-opportunities-and-industry-forecast-to-2026-2021-02-03?tesla=y

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Nano Biotechnology Market 2021, Size, Share, Global Industry Growth, Business Statistics, Top Leaders, Competitive Landscape, Forecast To 2027 KSU |...

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Is Ovid Therapeutics Inc (OVID) The Right Choice in Biotechnology? – InvestorsObserver

Thursday, February 4th, 2021

Ovid Therapeutics Inc (OVID) is near the middle in its industry group according to InvestorsObserver. OVID gets an overall rating of 40. That means it scores higher than 40 percent of stocks. Ovid Therapeutics Inc gets a 39 rank in the Biotechnology industry. Biotechnology is number 26 out of 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 40 would rank higher than 40 percent of all stocks.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Ovid Therapeutics Inc (OVID) stock is lower by -3.34% while the S&P 500 is higher by 0.66% as of 12:01 PM on Thursday, Feb 4. OVID has fallen -$0.11 from the previous closing price of $3.29 on volume of 1,234,638 shares. Over the past year the S&P 500 has risen 15.62% while OVID has fallen -20.30%. OVID lost -$1.39 per share the over the last 12 months.

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Is Geron Corporation (GERN) the Top Pick in the Biotechnology Industry? – InvestorsObserver

Thursday, February 4th, 2021

A rating of 73 puts Geron Corporation (GERN) near the top of the Biotechnology industry according to InvestorsObserver. Geron Corporation's score of 73 means it scores higher than 73% of stocks in the industry. Geron Corporation also received an overall rating of 61, putting it above 61% of all stocks. Biotechnology is ranked 26 out of the 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 61 would rank higher than 61 percent of all stocks.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Geron Corporation (GERN) stock is lower by -6.67% while the S&P 500 is higher by 0.66% as of 11:47 AM on Thursday, Feb 4. GERN is lower by -$0.14 from the previous closing price of $2.10 on volume of 5,084,909 shares. Over the past year the S&P 500 has risen 15.62% while GERN is higher by 48.48%. GERN lost -$0.35 per share the over the last 12 months.

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Is PDS Biotechnology Corp (PDSB) Stock Near the Top of the Biotechnology Industry? – InvestorsObserver

Thursday, February 4th, 2021

PDS Biotechnology Corp (PDSB) is near the top in its industry group according to InvestorsObserver. PDSB gets an overall rating of 77. That means it scores higher than 77 percent of stocks. PDS Biotechnology Corp gets a 94 rank in the Biotechnology industry. Biotechnology is number 24 out of 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

PDS Biotechnology Corp (PDSB) stock is down -11.08% while the S&P 500 is higher by 0.18% as of 11:54 AM on Wednesday, Feb 3. PDSB is down -$0.43 from the previous closing price of $3.88 on volume of 1,803,239 shares. Over the past year the S&P 500 is higher by 16.24% while PDSB is higher by 36.90%. PDSB lost -$1.57 per share the over the last 12 months.

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Biotechnology Crop Seeds Market Analysis and Demand with Forecast Overview to 2026 – AlgosOnline

Thursday, February 4th, 2021

A comprehensive research study on Biotechnology Crop Seeds market available at MarketStudyReport.com provides insights into the market size and growth trends of this industry over the forecast timeline. The study evaluates key aspects of Biotechnology Crop Seeds market in terms of the demand landscape, driving factors and growth strategies adopted by market players.

The study on Biotechnology Crop Seeds market provides thorough insights pertaining to major growth drivers, challenges, and opportunities that will influence the industry expansion in the forthcoming years.

Request a sample Report of Biotechnology Crop Seeds Market at:https://www.marketstudyreport.com/request-a-sample/3221257?utm_source=algosonline.com&utm_medium=SHR

According to the research document, the industry is expected to register XX% CAGR over the forecast period (2021-2026), subsequently accruing significant gains by the end of analysis timeframe.

The market is in a disarray due to the lockdowns imposed for limiting the spread of COVID-19 outbreak. In addition to the sudden slump of revenue, some businesses are expected to tackle a plethora of challenges post the pandemic.

Most of the businesses across various sectors have renewed their budgets to focus on profit gains in upcoming years. Our comprehensive analysis of the business sphere can help stakeholders in making sound decisions to compensate for market uncertainties and support them in building strong contingency plans.

Further, the report provides a granular assessment of the several industry segmentations to convey a deeper understanding of the areas with strong profit potential.

Key inclusions of the Biotechnology Crop Seeds market report:

Ask for Discount on Biotechnology Crop Seeds Market Report at:https://www.marketstudyreport.com/check-for-discount/3221257?utm_source=algosonline.com&utm_medium=SHR

Biotechnology Crop Seeds Market segments covered in the report:

Regional segmentation: North America, Europe, Asia-Pacific, South America, Middle East and Africa

Product types: Herbicide Tolerant and Insect Tolerant

Applications spectrum: Corn, Soybean, Cotton and Others

Competitive outlook: Bayer, Corteva, KWS SAAT, Limagrain and China National Chemical

For More Details On this Report: https://www.marketstudyreport.com/reports/global-biotechnology-crop-seeds-market-2021-by-manufacturers-regions-type-and-application-forecast-to-2026

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Is BIO-TECHNE Corp (TECH) the Top Pick in the Biotechnology Industry? – InvestorsObserver

Wednesday, February 3rd, 2021

BIO-TECHNE Corp (TECH) is around the top of the Biotechnology industry according to InvestorsObserver. TECH received an overall rating of 59, which means that it scores higher than 59 percent of all stocks. BIO-TECHNE Corp also achieved a score of 69 in the Biotechnology industry, putting it above 69 percent of Biotechnology stocks. Biotechnology is ranked 24 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

BIO-TECHNE Corp (TECH) stock is lower by -2.31% while the S&P 500 is higher by 0.47% as of 2:18 PM on Wednesday, Feb 3. TECH is lower by -$8.71 from the previous closing price of $376.76 on volume of 132,763 shares. Over the past year the S&P 500 is higher by 16.58% while TECH is higher by 76.63%. TECH earned $6.28 a per share in the over the last 12 months, giving it a price-to-earnings ratio of 58.64.

Click Here to get the full Stock Score Report on BIO-TECHNE Corp (TECH) Stock.

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Updates from Johnson County Community College: Developing the future with biotechnology – Shawnee Mission Post

Wednesday, February 3rd, 2021

Johnson County Community College is a great place for students to begin their educational journey and discover unique career paths. For example, introductory science courses at JCCC open the door to opportunities in specialized fields likebiotechnology.

Introducing a High-Demand Career Path

The field of biotechnology brings us so many amazing innovations in medicine, agriculture and animal health, says Heather Seitz, Professor of Biotechnology at JCCC. Its amazing learning about all the products that have been developed like recombinant insulin for diabetics, human growth hormone used to treat lots of growth disorders, crops that are drought-resistant and new vaccine technologies.

JCCCsIntroduction to Biotechnologydives into career exploration, history and applications of technology, molecular biology and bioethics. This course allows students to develop biotechnology skills while researching and developing an actual biotech product.

Students will learn how to create a product and then they will be able to develop, test and package the product for use by other courses on campus, says Seitz. Its an exciting opportunity for an aspiring biotechnologist.

A Culture of Success

As the field of biotechnology continues to grow, Seitz wants to spread the word to students considering a career in medicine.

I see tons of students who want to cure diseases and we need people working in the labs and helping to test and develop new strategies, she says. This work is really what cures diseases but its not something people often say when asked what they want to be when they grow up. I would argue that they just dont know the name of this important career.

Students can enter the biotechnology industry after earning an associate degree. Common careers include manufacturing technician, cell culture technician, instrument calibration technician, clinical research associate, clinical research administrator and medical laboratory assistant.

Location is Key

Kansas City is home to the Animal Health Corridor, the largest collection of animal health biotechnology companies in the world. In total, there are over 300 biotech companies in the Kansas City metro area, making JCCC an ideal location for this field of study.

Students seeking a bachelors degree in biotechnology wont have to look far. JCCCs courses transfer seamlessly to theUniversity of Kansas Edwards Campus biotechnology program. A bachelors degree allows students to work for companies that manufacture vaccines, develop new diagnostic tests and create personalized medicines and other products.

Randy Logan, Director of KUs biotechnology program, tells students that each class they take before their transfer is an important one.

The classes you take in your freshman and sophomore year lay the foundation for your downstream coursework, he said. You will build on that foundation and expand in complex and exciting ways. Focus on mastering the content you are given and never treat the classes as a check-the-box exercise.

Treating Mans Best Friend

JCCC alum Fareeha Lodhi started her work in the field of cancer treatment after completing the biotechnology program at KU Edwards. Lodhi is a laboratory manufacturing associate at ELIAS Animal Health in Kansas City. She studies immunotherapy treatment that creates cancer vaccines for canine patients.

Biotechnology is a vast field and is playing a vital role in the healthcare industry, especially the pharmaceutical and agricultural industry, she said. I was always fascinated by the lab environment, cell cultures and medicinal industry. To work in this field every day is a dream.

Start Your Journey

Ready to explore the field of biotechnology?Learn moreand check out oursteps to enroll!

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Updates from Johnson County Community College: Developing the future with biotechnology - Shawnee Mission Post

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Vir Biotechnology Announces New Data Highlighting the Importance of Targeting Conserved Regions of the SARS-CoV-2 Spike Protein in the Development of…

Wednesday, February 3rd, 2021

Scientists continuing to advance critical research on mechanisms of immune evasion exemplified by emerging SARS-CoV-2 variants

Study identifies the N-terminal domain of the SARS-CoV-2 spike protein as a target of potent neutralizing antibodies, but a target that can vary

Separate research results published in Cell characterize the virulence and antibody response to N439K, a prevalent variant of the SARS-CoV-2 receptor binding motif

SAN FRANCISCO, Feb. 01, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced the publication of new research characterizing a novel site of vulnerability on the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2) spike protein specifically the N-terminal domain (NTD). The study findings were made available online on bioRxiv on January 14, 2021 and have been submitted to a peer-reviewed journal for future print publication. This manuscript, together with data on immune evasion by mutations elsewhere in the spike protein published by scientists in Cell, begin to paint a comprehensive picture of the mechanisms that SARS-CoV-2 may utilize to evade immunity. Collectively, these data indicate the importance of carefully targeting conserved regions of the spike for vaccines and clinical monoclonal antibodies.

The receptor binding motif (RBM) of SARS-CoV-2, the region of the receptor binding domain (RBD) that interacts with the SARS-CoV-2 receptor, is a common target of COVID-19 natural and vaccine-induced immune responses, as well as monoclonal antibodies. However, recently published research has characterized the frequent occurrence of mutations within the RBM, highlighting the need for targeting alternate sites within the spike protein.

This new research indicates the NTD is another site on the SARS-CoV-2 spike protein that, like the RBM, contains mutations as well as deletions in emerging variants, said Davide Corti, Ph.D., senior vice president of antibody research for Vir. Mutations in these immunodominant domains can evade natural immune responses and are of concern for vaccines and for therapeutic monoclonal antibodies targeting these regions. This underscores the need to advance therapies that have a high barrier to resistance.

Story continues

Little is known about neutralizing antibodies that bind to the NTD and their contribution to protection from infection and disease. In this new study, researchers at Vir, the University of Washington and other universities in the United States and Europe isolated and extensively characterized 41 human monoclonal antibodies that recognize the SARS-CoV-2 NTD. A subset of these NTD-specific monoclonal antibodies neutralize SARS-CoV-2 with potency similar to potential best-in-class monoclonal antibodies that target the RBD. Notably, several new SARS-CoV-2 genetic variants, including the widely prevalent variants identified in South Africa and the UK, were found to possess frequent mutations in the NTD.

These new findings build upon recent research published in Cell by Vir scientists in collaboration with colleagues at MRC-University of Glasgow Centre for Virus Research, which demonstrate the RBM of the SARS-CoV-2 spike protein a major target of neutralizing monoclonal antibodies is particularly variable.

Our ongoing effort to characterize the SARS-CoV-2 spike protein is proving ever more critical as new variants continue to emerge. These new findings reinforce the approach we have taken with our monoclonal antibody, VIR-7831, which is currently in Phase 3 trials, said George Scangos, Ph.D., chief executive officer of Vir. By targeting a very conserved region of the RBD, VIR-7831 was designed to be effective against SARS-CoV-2 and variants that might emerge in this outbreak or future outbreaks of related viruses.

The findings published in Cell characterize the virulence, fitness, clinical and epidemiologic impact, molecular features and immune response to N439K, a prevalent RBM variant of the SARS-CoV-2 spike protein first identified in Scotland in March 2020. Since then, a second lineage has independently emerged in other European countries, which, by January 2021, was detected in more than 30 countries across the globe. Although N439K variants are not believed to be more virulent or transmissible than the original SARS-CoV-2 strain, this research is the first to demonstrate mutations that maintain viral fitness can evade immunity.

To understand whether and how the N439K mutation might evade immunity, researchers in the findings published in Cell noted the binding of polyclonal sera to the SARS-CoV-2 spike was reduced by the mutation in a sizeable fraction of the 445 samples obtained from recovered individuals. Additionally, out of 144 human neutralizing mAbs isolated from individuals who recovered from SARS-CoV-2 infection early in the pandemic, a significant number failed to efficiently recognize N439K. When tested across four clinical-stage antibodies S309 (the precursor of VIR-7831), LY-CoV555, REGN10933 and REGN10987 S309, which targets a non-RBM epitope, LY-CoV555 and REGN10933 were capable of neutralizing the N439K variant.

About VIR-7831VIR-7831 is an investigational dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About Vir BiotechnologyVir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit http://www.vir.bio.

Vir Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as may, will, plan, potential, aim, promising and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Virs expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding statements regarding print publication of Virs research in a peer-reviewed journal, the emergence of new SARS-CoV-2 variants, the identification of N-terminal domain as a target of potent neutralizing antibodies, the importance of advancing therapies that have a high barrier to resistance and the potential ability of VIR-7831 to evade such variants in the protection and treatment of COVID-19 and in the prevention of future pandemics of related coronaviruses. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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Is Allovir Inc (ALVR) The Right Choice in Biotechnology? – InvestorsObserver

Wednesday, February 3rd, 2021

The 42 rating InvestorsObserver gives to Allovir Inc (ALVR) stock puts it near the middle of the Biotechnology industry. In addition to scoring higher than 41 percent of stocks in the Biotechnology industry, ALVRs 42 overall rating means the stock scores better than 42 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 42 would rank higher than 42 percent of all stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Allovir Inc (ALVR) stock is down -5% while the S&P 500 is up 0.36% as of 1:25 PM on Wednesday, Feb 3. ALVR has fallen -$2.23 from the previous closing price of $44.63 on volume of 119,688 shares. Over the past year the S&P 500 is up 17.84% while ALVR is up 1377.35%. ALVR lost -$0.44 per share the over the last 12 months.

Click Here to get the full Stock Score Report on Allovir Inc (ALVR) Stock.

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Joint Team from MIT and Synlogic Named a Biotechnology Grand Challenge Winner by Air Force Research Laboratory – PRNewswire

Wednesday, February 3rd, 2021

CAMBRIDGE, Mass., Feb. 2, 2021 /PRNewswire/ -- A collaboration between MIT Voigt Lab and Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, has been recognized by the Air Force Research Laboratory (AFRL) as a Biotechnology Grand Challenge Winner. One of four winning teams, the joint team comprised of MIT and Synlogic was awarded $1 million in an effort to spearhead innovation among small businesses in the field of biotechnology for the Department of Defense.

"We are honored to be recognized by the AFRL and are thrilled to collaborate with Synlogic to achieve this success," said Christopher Voigt, MIT Professor of Biological Engineering and Principal Investigator for the MIT Voigt Lab. "Our challenge was determining which organization would possess the proven expertise in both the development and manufacturing of novel biotherapeutic products, and we couldn't be happier that we have found that partner in Synlogic."

Christopher Voigt is an expert in synthetic biology and biotechnology with extensive research programs in defense, chemistry/materials, and agriculture. The focus of the Voigt Lab is to develop new experimental and theoretical methods to push the scale of genetic engineering, with the ultimate objective of genome design. This will impact the engineering of biology for a broad range of applications, including agriculture, materials, chemicals, and medicine. Professor Voigt's research spans applications for the Army, Navy, and Air Force, and he works closely with scientists across the service labs as well as hosting DoD researchers at MIT.

"Our internal and fully integrated Process Development & Manufacturing Sciences organization has demonstrated leading technical expertise in the field of Synthetic Biotic medicines and we look forward to applying innovative solutions for today's real-life challenges," said Antoine Awad, Synlogic's Chief Operating Officer."As we develop our internal pipeline we are excited to leverage our core capabilities to advance innovative partner projects, such as applying our bioprocess and manufacturing to advance the goals of the AFRL."

Together, Synlogic and the Voigt Lab will collaborate to generate and manufacture engineered strains by performing an assessment of process manufacturability, with optimization performed to maximize high cell density growth and high end of fermentation (EOF) viability. The goal of this work is to produce a live bacterial therapeutic that would improve pilot performance and decision-making when battling fatigue during long missions.

Learn more about Synlogic at http://www.synlogictx.com.

About Synlogic

Synlogic is bringing the transformative potential of synthetic biology to medicine. With a premiere synthetic biology platform that leverages a reproducible, modular approach to microbial engineering, Synlogic designs Synthetic Biotic medicines that target validated underlying biology to treat disease in new ways. Synlogic's proprietary pipeline includes Synthetic Biotic medicines for the treatment of metabolic disorders including Phenylketonuria (PKU) and Enteric Hyperoxaluria (HOX). The company is also building a portfolio of partner-able assets in immunology and oncology.

Forward-Looking Statements

This press release contains "forward-looking statements" that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, clinical development plans, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Synlogic may identify forward-looking statements. Examples of forward-looking statements, include, but are not limited to, statements regarding the potential of Synlogic's platform to develop therapeutics to address a wide range of diseases including: cancer, inborn errors of metabolism, and inflammatory and immune disorders; the future clinical development of Synthetic Biotic medicines; the approach Synlogic is taking to discover and develop novel therapeutics using synthetic biology; and the expected timing of Synlogic's clinical trials including the Phase 1 study for SYNB1891 and SYNB8802 and the Phase 2 study of SYNB1618, and availability of clinical trial data from that study and other studies.

Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including: the uncertainties inherent in the clinical and preclinical development process; the ability ofSynlogicto protect its intellectual property rights; and legislative, regulatory, political and economic developments, as well as those risks identified under the heading "Risk Factors" inSynlogic'sfilings with theSEC. The forward-looking statements contained in this press release reflectSynlogic'scurrent views with respect to future events.Synlogicanticipates that subsequent events and developments will cause its views to change. However, whileSynlogicmay elect to update these forward-looking statements in the future,Synlogicspecifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Synlogic's view as of any date subsequent to the date hereof.

SOURCE Synlogic, Inc.

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Is Arcutis Biotherapeutics Inc (ARQT) a Winner in the Biotechnology Industry? – InvestorsObserver

Wednesday, February 3rd, 2021

Arcutis Biotherapeutics Inc (ARQT) is near the top in its industry group according to InvestorsObserver. ARQT gets an overall rating of 64. That means it scores higher than 64 percent of stocks. Arcutis Biotherapeutics Inc gets a 76 rank in the Biotechnology industry. Biotechnology is number 24 out of 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Arcutis Biotherapeutics Inc (ARQT) stock is lower by -3.74% while the S&P 500 is up 0.18% as of 11:53 AM on Wednesday, Feb 3. ARQT is down -$1.35 from the previous closing price of $36.10 on volume of 940,229 shares. Over the past year the S&P 500 has risen 16.24% while ARQT is up 35.53%. ARQT lost -$3.45 per share the over the last 12 months.

Click Here to get the full Stock Score Report on Arcutis Biotherapeutics Inc (ARQT) Stock.

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Analysts Offer Insights on Healthcare Companies: PDS Biotechnology (PDSB) and HCA Healthcare (HCA) – Smarter Analyst

Wednesday, February 3rd, 2021

Theres a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on PDS Biotechnology (PDSB) and HCA Healthcare (HCA) with bullish sentiments.

PDS Biotechnology (PDSB)

In a report released today, Joseph Pantginis from H.C. Wainwright reiterated a Buy rating on PDS Biotechnology, with a price target of $6.00. The companys shares closed last Wednesday at $3.48.

According to TipRanks.com, Pantginis is a top 100 analyst with an average return of 47.3% and a 69.5% success rate. Pantginis covers the Healthcare sector, focusing on stocks such as Applied Genetic Technologies, Lineage Cell Therapeutics, and Catabasis Pharmaceuticals.

The word on The Street in general, suggests a Strong Buy analyst consensus rating for PDS Biotechnology with a $6.53 average price target.

See todays analyst top recommended stocks >>

HCA Healthcare (HCA)

Credit Suisse analyst A.J. Rice maintained a Buy rating on HCA Healthcare today and set a price target of $201.00. The companys shares closed last Wednesday at $170.81, close to its 52-week high of $174.55.

According to TipRanks.com, Rice is a 4-star analyst with an average return of 9.9% and a 63.9% success rate. Rice covers the Healthcare sector, focusing on stocks such as Genesis Healthcare, Acadia Healthcare, and Encompass Health.

HCA Healthcare has an analyst consensus of Strong Buy, with a price target consensus of $191.31, which is a 15.1% upside from current levels. In a report released yesterday, Oppenheimer also maintained a Buy rating on the stock with a $200.00 price target.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

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Analysts Offer Insights on Healthcare Companies: PDS Biotechnology (PDSB) and HCA Healthcare (HCA) - Smarter Analyst

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PDS Biotechnology Corp (PDSB) Stock: What Does the Chart Say? – InvestorsObserver

Wednesday, February 3rd, 2021

Overall market sentiment has been high on PDS Biotechnology Corp (PDSB) stock lately. PDSB receives a Bullish rating from InvestorsObserver's Stock Sentiment Indicator.

Sentiment is a very short-term indicator that is entirely technical. There is no information about the health of profitability of the underlying company in our sentiment score.

As a technical indicator, news about the stock, or company, such as an earnings release or other event, could move the stock counter to the recent trend.

Price action is generally the best indicator of sentiment. For a stock to go up, investors must feel good about it. Similarly, a stock that is in a downtrend must be out of favor.

InvestorsObservers Sentiment Indicator considers price action and recent trends in volume. Increasing volumes often mean that a trend is strengthening, while decreasing volumes can signal that a reversal could come soon.

The options market is another place to get signals about sentiment. Since options allow investors to place bets on the price of a stock, we consider the ratio of calls and puts for stocks where options are available.

PDS Biotechnology Corp (PDSB) stock is trading at $3.81 as of 3:18 PM on Tuesday, Feb 2, a rise of $0.19, or 5.25% from the previous closing price of $3.62. The stock has traded between $3.48 and $3.92 so far today. Volume today is more active than usual. So far 665,239 shares have traded compared to average volume of 485,122 shares.

To see InvestorsObserver's Sentiment Score for PDS Biotechnology Corp click here.

PDS Biotechnology Corp operates as a clinical stage biotechnology company, principally involved in drug discovery in the United States. It is primarily engaged in the treatment of various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its products are based on the proprietary Versamune platform technology, which activates and directs the human immune system to unleash a powerful and targeted attack against cancer cells.

Click Here to get the full Stock Score Report on PDS Biotechnology Corp (PDSB) Stock.

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PDS Biotechnology Corp (PDSB) Stock: What Does the Chart Say? - InvestorsObserver

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Should You Buy Ovid Therapeutics Inc (OVID) in Biotechnology Industry? – InvestorsObserver

Wednesday, February 3rd, 2021

The 39 rating InvestorsObserver gives to Ovid Therapeutics Inc (OVID) stock puts it near the middle of the Biotechnology industry. In addition to scoring higher than 36 percent of stocks in the Biotechnology industry, OVIDs 39 overall rating means the stock scores better than 39 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 39 would rank higher than 39 percent of all stocks.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Ovid Therapeutics Inc (OVID) stock is trading at $2.89 as of 2:58 PM on Tuesday, Feb 2, an increase of $0.09, or 3.21% from the previous closing price of $2.80. The stock has traded between $2.70 and $3.10 so far today. Volume today is more active than usual. So far 3,194,206 shares have traded compared to average volume of 1,863,832 shares.

Click Here to get the full Stock Score Report on Ovid Therapeutics Inc (OVID) Stock.

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Should You Buy Ovid Therapeutics Inc (OVID) in Biotechnology Industry? - InvestorsObserver

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Is Codexis, Inc. (CDXS) the Top Pick in the Biotechnology Industry? – InvestorsObserver

Wednesday, February 3rd, 2021

A rating of 81 puts Codexis, Inc. (CDXS) near the top of the Biotechnology industry according to InvestorsObserver. Codexis, Inc.'s score of 81 means it scores higher than 81% of stocks in the industry. Codexis, Inc. also received an overall rating of 64, putting it above 64% of all stocks. Biotechnology is ranked 33 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Codexis, Inc. (CDXS) stock is trading at $26.13 as of 10:16 AM on Tuesday, Feb 2, a rise of $2.22, or 9.28% from the previous closing price of $23.91. The stock has traded between $24.93 and $26.71 so far today. Volume today is light. So far 253,983 shares have traded compared to average volume of 799,470 shares.

Click Here to get the full Stock Score Report on Codexis, Inc. (CDXS) Stock.

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Is Amicus Therapeutics, Inc. (FOLD) Stock Near the Top of the Biotechnology Industry? – InvestorsObserver

Wednesday, February 3rd, 2021

The 64 rating InvestorsObserver gives to Amicus Therapeutics, Inc. (FOLD) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 81 percent of stocks in the Biotechnology industry, FOLDs 64 overall rating means the stock scores better than 64 percent of all stocks.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

Amicus Therapeutics, Inc. (FOLD) stock is trading at $20.64 as of 11:38 AM on Tuesday, Feb 2, a gain of $1.39, or 7.22% from the previous closing price of $19.25. The stock has traded between $19.22 and $20.84 so far today. Volume today is 2,304,746 compared to average volume of 2,548,983.

Click Here to get the full Stock Score Report on Amicus Therapeutics, Inc. (FOLD) Stock.

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Is Prothena Corporation PLC (PRTA) the Top Pick in the Biotechnology Industry? – InvestorsObserver

Wednesday, February 3rd, 2021

A rating of 50 puts Prothena Corporation PLC (PRTA) near the middle of the Biotechnology industry according to InvestorsObserver. Prothena Corporation PLC's score of 50 means it scores higher than 50% of stocks in the industry. Prothena Corporation PLC also received an overall rating of 45, putting it above 45% of all stocks. Biotechnology is ranked 33 out of the 148 industries.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Prothena Corporation PLC (PRTA) stock is trading at $13.85 as of 10:16 AM on Tuesday, Feb 2, a gain of $2.85, or 25.87% from the previous closing price of $11.00. The stock has traded between $13.00 and $14.70 so far today. Volume today is above average. So far 532,574 shares have traded compared to average volume of 250,348 shares.

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Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18-Mutated, Metastatic Non-Small Cell Lung…

Wednesday, February 3rd, 2021

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented interim results from the ongoing SUMMIT trial of neratinib in the cohort of metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor (EGFR) exon 18 mutations who have been previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI). The data were presented in an oral discussion at the 2020 World Conference on Lung Cancer (WCLC 2020) presented by the International Association for the Study of Lung Cancer (IASLC) that is currently taking place in Singapore. The presentation, entitled, Neratinib in Pretreated EGFR Exon 18-Mutated Non-Small Cell Lung Cancer (NSCLC): Initial Findings from the SUMMIT Basket Trial, is being presented at an Oral Session by Valentina Boni, MD, PhD, START Madrid-CIOCC, Centro Oncologico Clara Campal, HM Sanchinarro.

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations. In the EGFR exon 18 mutation cohort, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR TKI nave or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib daily as a single agent.

In this cohort of 11, patients had received a median of 2 prior lines of therapy in the metastatic setting (range 1-3 prior regimens) before entering the trial. 10 patients had been previously treated with an EGFR targeted tyrosine kinase inhibitor (gefitinib, erlotinib, osimertinib and/or afatinib).

The interim efficacy results from the trial showed that for the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response, which included 4 patients (40%) with a confirmed partial response. 8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). The median duration of response was 7.5 months and the median progression-free survival was 9.1 months. The success criteria for both the 1st stage and the 2nd stage of the Simons 2-stage design were met and enrollment in the 2nd stage of this cohort continues.

The safety profile observed in the subgroup of patients with EGFR exon 18-mutated NSCLC showed that for the 11 patients who received neratinib in the trial, there were no reports of grade 3 or higher diarrhea. 4 patients (36%) reported grade 1 and 1 patient (9%) reported grade 2 diarrhea. No patients required a dose hold, dose reduction, hospitalization or permanently discontinued neratinib due to diarrhea.

Dr. Boni, an investigator of the trial, said, We are very excited about these early study results in EGFR exon 18 mutant lung cancer, for whom very few effective treatment options are available once they fail first-line FDA approved EGFR TKI therapy.

Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, Associate Director of Drug Development, and Director of Clinical Trials in Thoracic Oncology at UCLA, said, These early study results open up a potentially effective option for EGFR exon 18 mutation-positive NSCLC patients once they fail first-line FDA approved TKI therapy.

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, We are pleased to present this data at the World Conference on Lung Cancer and increase the awareness of neratinibs activity in this patient population within the lung cancer community. We are continuing to enroll this cohort of patients in the SUMMIT trial and we continue to believe that there is a need for new treatments for patients with EGFR exon 18-mutated NSCLC who have previously been treated with EGFR targeted tyrosine kinase inhibitors.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

IMPORTANT SAFETY INFORMATION

NERLYNX (neratinib) tablets, for oral use

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

ADVERSE REACTIONS:

The most common adverse reactions (reported in 5% of patients) were as follows:

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

DRUG INTERACTIONS:

USE IN SPECIFIC POPULATIONS:

Lactation: Advise women not to breastfeed.

Please see Full Prescribing Information for additional safety information.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at http://www.NERLYNX.com or 1-855-816-5421.

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