StemCell Therapy

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved.  No other deficiencies in the application were noted by the FDA.  Alvotech provided the FDA comprehensive responses to the inspection observations on April 3, 2023, and is awaiting communication from the agency assessing those responses.

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Alvotech Provides Regulatory Update on AVT02 Biologics License Application

Vivoryon Therapeutics N.V. to Report Full Year 2022 Financial Results and Operational Progress on April 19, 2023

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Vivoryon Therapeutics N.V. to Report Full Year 2022 Financial Results and Operational Progress on April 19, 2023

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Additional Future Royalty Revenue Stream for Nicox from 2024 following New Drug Application Submission for ZERVIATE in China

Oslo, 14 April 2023: In connection with the Annual General Meeting of Ultimovacs ASA to be held on 20 April 2023, Jónas Einarsson, Chair of the Board of Directors, has so far received proxy based voting rights without voting instructions for 11,364,278 shares, representing 33.04% of the total voting rights in the company.

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Ultimovacs ASA – Disclosure of voting rights of Annual General Meeting

Garching / München, 14. April 2023 – ITM Isotope Technologies Munich SE (ITM), ein führendes radiopharmazeutisches Biotech-Unternehmen, nimmt an der 61. Jahrestagung der Deutschen Gesellschaft für Nuklearmedizin vom 19. – 22. April 2023 in Leipzig teil und veranstaltet am 20. April ein Lunch-Symposium mit dem Titel „Lutetium von A bis Z: Von Angebot und Nachfrage über Dosimetrie bis zu Zoledronat“. Zudem präsentiert sich ITM mit einem Messestand (Nr. A17).

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ITM lädt zu Symposium und Messestand auf der Jahrestagung der Deutschen Gesellschaft für Nuklearmedizin in Leipzig ein

Launch of cell-free DNA (cfDNA) next-generation sequencing kits to test liquid biopsies // Study to demonstrate QIAGEN’s expertise in detecting disease-relevant cfDNA mutations // New pan-cancer panels for digital PCR platform QIAcuity to be launched in fall 2023 Launch of cell-free DNA (cfDNA) next-generation sequencing kits to test liquid biopsies // Study to demonstrate QIAGEN’s expertise in detecting disease-relevant cfDNA mutations // New pan-cancer panels for digital PCR platform QIAcuity to be launched in fall 2023

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QIAGEN showcases latest technologies to advance cancer research at AACR Annual Meeting 2023

MALVERN, Pa., April 14, 2023 (GLOBE NEWSWIRE) --  Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced positive preliminary data among retinitis pigmentosa (RP) participants treated in the first two cohorts of the Phase 1/2 trial to assess the safety and efficacy of OCU400 for RP associated with NR2E3 and Rhodopsin (RHO) mutations and Leber Congenital Amaurosis (LCA) with mutation(s) in the CEP290 gene. These preliminary results provide support that OCU400, Ocugen’s first-in-class therapeutic approach utilizing a proprietary modifier gene therapy platform, has the potential to be a gene-agnostic therapeutic for RP and LCA patients with inherited retinal degeneration.

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Ocugen Announces Positive Preliminary Safety and Efficacy Results from the Phase 1/2 Trial of OCU400, a Modifier Gene Therapy Product Candidate, for...

CAMBRIDGE, Mass. and ROSTOCK, Germany, and BERLIN, April 14, 2023 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, today announced its conference schedule for April 2023. CENTOGENE representatives will be attending events in Spain, the U.S., and Germany and will be available to discuss Pharma, CRO, and Diagnostic collaboration opportunities. The Company invites attendees to schedule one-on-one meetings in advance.

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CENTOGENE to Participate in Upcoming Conferences in April

SEATTLE and VANCOUVER, British Columbia, April 14, 2023 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine dependence, today announced that John Bencich, CEO of Achieve, will present at the Life Science Innovation Northwest (LSINW) 2023 Conference being held at the Seattle Convention Center April 25-26, 2023.

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Achieve Life Sciences to Present at Life Science Innovation Northwest 2023 Conference

NEW YORK and LONDON, April 14, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced the company will host a virtual key opinion leader event on May 22, 2023 at 2 pm ET to discuss the treatment landscape in geographic atrophy (GA) and the potential for long-acting PAS-nomacopan to address significant unmet needs. Akari’s lead asset is investigational nomacopan, a novel bispecific inhibitor of both complement C5 and leukotriene B4 (LTB4). Long-acting PAS-nomacopan is currently in pre-clinical development as a potential treatment for GA.

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Akari Therapeutics to Host Key Opinion Leader Webinar on Geographic Atrophy and the Potential of Long-Acting PAS-Nomacopan to Address Significant...

CAMBRIDGE, Mass., April 14, 2023 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset clinical-stage biopharmaceutical company, focused on identifying, developing and commercializing treatments in high unmet need areas involving rare diseases and multi-drug resistant (MDR) bacterial infections, today announced two poster presentations at the 33rd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) being held April 15-18, 2023, in Copenhagen, Denmark.

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Spero Therapeutics to Present Data at the 33rd European Congress of Clinical Microbiology and Infectious Diseases

BOSTON, April 14, 2023 (GLOBE NEWSWIRE) -- Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced Yves Sabbagh, Ph.D., the company’s senior vice president and chief scientific officer, will present recently announced preliminary data from the ongoing Phase 1/2 clinical trial of INZ-701 in patients with ENPP1 Deficiency in an oral presentation on Monday, April 17 at the European Calcified Tissue Society Congress (ECTS) in Liverpool, UK.

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Inozyme Pharma to Present Recently Announced Preliminary Data from Ongoing Phase 1/2 Trial in ENPP1 Deficiency at the European Calcified Tissue...

SOUTH SAN FRANCISCO, Calif., April 14, 2023 (GLOBE NEWSWIRE) -- Senti Biosciences, Inc. (Nasdaq: SNTI) (“Senti Bio”), a biotechnology company innovating next-generation cell and gene therapies using its proprietary Gene Circuit platform, today announced its participation at the following investor conferences:

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Senti Bio to Participate in Upcoming Investor Conferences

LONDON, Ontario, April 14, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce that Institutional Shareholders Services Inc. (“ISS”) has recommended Sernova’s shareholders vote FOR all of Sernova’s management nominees using only management’s WHITE proxy.

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Institutional Shareholder Services Inc. Recommends Senova’s Shareholders Vote FOR all Management Nominees on Management’s White Proxy

Two late-breaking abstracts will be presented Two late-breaking abstracts will be presented

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Araris Biotech AG Presents Preclinical Data Highlighting Stable and Efficacious Low Drug-Load ADCs at American Association for Cancer Research (AACR)...

- Data highlight favorable preclinical profiles for two chemically-distinct allosteric, oral small molecule KRAS inhibitors with potent anti-tumor activity -

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Quanta Therapeutics Presents Data from KRAS Inhibitor Pipeline at Annual AACR Meeting in Late-Breaking Research Session

LONDON, Ontario, April 14, 2023 (GLOBE NEWSWIRE) -- Sernova Corp. (“Sernova” or the “Corporation”) (TSX: SVA) (OTCQB: SEOVF) (FSE/XETRA: PSH), a clinical-stage company and leader in cell therapeutics, is pleased to announce that Institutional Shareholders Services Inc. (“ISS”) has recommended Sernova’s shareholders vote FOR all of Sernova’s management nominees using only management’s WHITE proxy.

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UPDATE -- Institutional Shareholder Services Inc. Recommends Sernova’s Shareholders Vote FOR all Management Nominees on Management’s White Proxy

Regulated Information

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Oxurion Receives Transparency Notification from Atlas Special Opportunities LLC

PETACH TIKVA, Israel, April 14, 2023 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced it has received a letter from the Listing Qualifications staff of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Global Market. Nasdaq Listing Rule 5450(b)(1) requires listed companies to maintain stockholders’ equity of at least $10,000,000, and the Company’s stockholders’ equity was $5,829,000 as of December 31, 2022. In accordance with Nasdaq rules, the Company has 45 calendar days, or until May 25, 2023, to submit a plan to regain compliance. If the plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from the date of the letter to evidence compliance. The notification letter has no immediate effect on the Company’s listing on the Nasdaq Capital Market, and during the grace period, as may be extended, the Company’s ordinary shares will continue to trade on Nasdaq under the symbol “PYPD”.

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PolyPid Announces Receipt of Nasdaq Notification of Minimum Stockholders’ Equity Non-Compliance

BEDFORD, Mass., April 14, 2023 (GLOBE NEWSWIRE) -- Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, announced multiple scientific presentations at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting being held April 23 - 27 in New Orleans, Louisiana.

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Ocular Therapeutix™ To Present Pre-Clinical and Clinical Data at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting