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Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti™ (cipaglucosidase alfa) for Late-Onset Pompe Disease

Posted: December 18, 2022 at 12:22 am

CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data

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Amicus Therapeutics Receives Positive CHMP Opinion for Pombiliti™ (cipaglucosidase alfa) for Late-Onset Pompe Disease

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Biofrontera Inc. Announces Voting Results from 2022 Annual Meeting of Stockholders

Posted: December 18, 2022 at 12:22 am

WOBURN, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, today announced the final voting results from its 2022 Annual Meeting of Stockholders held on December 12, 2022.

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Biofrontera Inc. Announces Voting Results from 2022 Annual Meeting of Stockholders

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Arvinas Announces Changes to its Board of Directors

Posted: December 18, 2022 at 12:22 am

NEW HAVEN, Conn., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, today announced that Brad Margus, M.B.A., has stepped down from the company’s Board and Everett Cunningham has been appointed to join.

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Arvinas Announces Changes to its Board of Directors

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Societal CDMO Completes Strategic Recast of Capital Structure Highlighted by Reduction and Refinancing of Outstanding Debt

Posted: December 18, 2022 at 12:22 am

Closing of Three Separate Transformative Capital Financings, Including Two Significant Non-Dilutive Transactions, Generates Combined Gross Proceeds of More than $100 Million Which Reduce Outstanding Debt from $100 Million to $36.9 Million

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Societal CDMO Completes Strategic Recast of Capital Structure Highlighted by Reduction and Refinancing of Outstanding Debt

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The atai Fellowship Fund in Psychedelic Neuroscience Announces its First Cohort at Massachusetts General Hospital

Posted: December 18, 2022 at 12:22 am

NEW YORK and BERLIN, Dec. 16, 2022 (GLOBE NEWSWIRE) -- atai Impact, the philanthropic arm of atai Life Sciences N.V. (NASDAQ: ATAI) (“atai”), today announced the first cohort of the atai Fellowship Fund in Psychedelic Neuroscience (the “Fellowship Fund”) at Massachusetts General Hospital (“MGH”) Center for the Neuroscience of Psychedelics. The $2 million Fellowship Fund was announced in December 2021 to facilitate research into the potential of psychedelics to address unmet patient needs in mental health and support promising graduate students and other trainees in furthering their professional careers in this emerging field.

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The atai Fellowship Fund in Psychedelic Neuroscience Announces its First Cohort at Massachusetts General Hospital

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Chalice Brands Reports Select Preliminary Unaudited Fiscal Year End 2021 Results and 2021 Operational Update

Posted: December 18, 2022 at 12:22 am

PORTLAND, Ore., Dec. 16, 2022 (GLOBE NEWSWIRE) -- Chalice Brands Ltd. (CSE: CHAL) (OTCQB: CHALF) (the “Company” or “Chalice Brands”), a premier consumer-driven cannabis company specializing in retail, production, processing, wholesale, and distribution, today announces select preliminary unaudited financial results for the year ended December 31, 2021. All financial information is provided in U.S. dollars unless otherwise indicated.

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Chalice Brands Reports Select Preliminary Unaudited Fiscal Year End 2021 Results and 2021 Operational Update

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DEINOVE – Update on the Receivership Proceedings

Posted: December 18, 2022 at 12:22 am

DEINOVE (Euronext Growth Paris: ALDEI), a French biotech company, pioneer in the exploration and exploitation of bacterial biodiversity to address the urgent, global challenge of antibiotic resistance, announces that, in the context of the receivership proceedings (“procédure de redressement judiciaire”) opened on November 7, 2022, the Montpellier Commercial Court has met on December 16, 2022, and postponed the examination of the case to January 13, 2023. The continuation of the observation period (“période d'observation”) was requested by the bodies of the proceedings and the company DEINOVE.

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The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

Posted: December 18, 2022 at 12:22 am

NEW YORK, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the European Committee for Medicinal Products for Human use (“CHMP”) has adopted a negative opinion recommending a refusal of the marketing authorization for omburtamab for the treatment of CNS/leptomeningeal metastasis from neuroblastoma in Europe.

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The CHMP has Adopted a Negative Opinion for Omburtamab for the Treatment of CNS/LM Metastasis from Neuroblastoma in Europe

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EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

Posted: December 18, 2022 at 12:22 am

WATERTOWN, Mass., Dec. 16, 2022 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced that the Company granted non-statutory stock options to a new employee as an inducement award outside the Company’s 2016 Long-Term Incentive Plan in accordance with NASDAQ Listing Rule 5635(c)(4).

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EyePoint Pharmaceuticals Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4)

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CENTOGENE Receives Nasdaq Non-Compliance Notice

Posted: December 18, 2022 at 12:22 am

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, Dec. 16, 2022 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answers in rare and neurodegenerative diseases, has received notification from the Nasdaq Stock Market LLC Listing Qualifications Department that it was not in compliance with the minimum bid price requirement set forth in Nasdaq Rule 5450(a)(1) since the closing bid price for the Company's common shares listed on Nasdaq was below US$1.00 for 30 consecutive business days. Nasdaq Rule 5450(a)(1) requires the shares to maintain a minimum bid price of US$1.00 per share, and Nasdaq Rule 5810(c)(3)(A) provides that failure to meet such a requirement exists when the bid price of the shares is below US$1.00 for a period of 30 consecutive business days. These notifications do not impact the Company’s listing on the Nasdaq Global Market at this time. In accordance with Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days from the date of notification, or until June 12, 2023, to regain compliance with the minimum bid price requirement, during which time the shares will continue to trade on the Nasdaq Global Market. If at any time during the 180-calendar day period, the bid price of the shares closes at or above US$1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that the Company has achieved compliance with the minimum bid price requirement and will consider such deficiency matters closed.

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