Company now expects to release topline 52-week results from MAESTRO-NAFLD-1 in January 2022 Company now expects to release topline 52-week results from MAESTRO-NAFLD-1 in January 2022
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Madrigal Provides Update on Timeline for Topline Results from the Phase 3 MAESTRO-NAFLD-1 Clinical Trial of Resmetirom
WOBURN, Mass., Dec. 30, 2021 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced that through the exercise of outstanding warrants the majority ownership of Biofrontera AG was diluted below 50%. Biofrontera AG’s shareholding in Biofrontera Inc. of 8,000,000 shares is unchanged, but now represents approximately 47% of the currently outstanding shares. As a result, Biofrontera Inc. is no longer considered a subsidiary of Biofrontera AG. Biofrontera Inc.’s common stock and warrants are traded on the Nasdaq Capital Market under the ticker symbols “BFRI” and “BFRIW,” respectively.
MALVERN, Pa., Dec. 30, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of candidate vaccine, COVAXIN™ (BBV152), in children, aged 2 – 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv. Using a two-dose regimen administered 28-days apart, antibody responses in subjects were comparable to adult data from a previous phase 3 study. Those results demonstrated a greater than 93% reduction in severe disease. These pediatric data were the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children 2-18 on November 5, 2021.
Company announcement – No. 78 / 2021
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Total number of shares and voting rights in Zealand Pharma at December 30, 2021
NEW YORK and LONDON, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX) (“Akari” or the “Company”), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, today announced that it has entered into definitive agreements with institutional investors and accredited investors, led by existing investors of the Company, including Dr. Ray Prudo, the Company’s Chairman, to receive gross proceeds of approximately $6.0 million.
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Akari Therapeutics, Plc Announces $6.0 Million Registered Direct Offering
THE WOODLANDS, Texas, Dec. 30, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of sotagliflozin to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure irrespective of left ventricular ejection fraction. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
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Lexicon Submits New Drug Application for Sotagliflozin for the Treatment of Heart Failure in Adults With Type 2 Diabetes
HALIFAX, Nova Scotia, Dec. 30, 2021 (GLOBE NEWSWIRE) -- MedMira Inc. (MedMira) (TSXV: MIR), reported today on its financial results for the quarter ended October 31, 2021.
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MedMira Reports First Quarter Results FY2022
DURHAM, N.C., Dec. 31, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Surgical Key Opinion Leaders (KOLs) Alan P. Kypson, M.D., FACS; Luigi Pascarella, M.D., FACS; and Todd E. Rasmussen, M.D., FACS, (Col, ret. USAF MC), to new advisory positions. In these roles, the KOLs will lend their expertise and support to guide the education and clinical advancement efforts of the Human Acellular VesselTM (HAV) and help identify opportunities to advance the Company's early stage complex tissue constructs pipeline and platform.
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Humacyte Announces the Appointments of Three Surgical and Cardiovascular Opinion Leaders to Advisory Roles
The Phase 1 Study Will be Comprised of Two Parts: Phase 1a Dose-escalation that will Evaluate the Safety and Tolerability of NXP800 in Patients with Advanced Solid Tumors, Followed by a Phase 1b to Evaluate Preliminary Efficacy in Specific Populations The Phase 1 Study Will be Comprised of Two Parts: Phase 1a Dose-escalation that will Evaluate the Safety and Tolerability of NXP800 in Patients with Advanced Solid Tumors, Followed by a Phase 1b to Evaluate Preliminary Efficacy in Specific Populations
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Nuvectis Pharma Initiates Phase 1 Clinical Trial of NXP800