Poland and U.K. Regulatory Authorities – URPL and MHRA – Approve Use of New, Higher-Yielding Manufacturing Process for Nomacopan in Pivotal Clinical Study
Akari Therapeutics Plc - American Depositary Shares (AKTX)
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Source: GlobeNewswire
Third generation drug substance manufacturing process increases the final yield of nomacopan by at least 5-fold, improving cost efficiencies in the continuing Phase 3 clinical trial of nomacopan in pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA) advancing to pivotal Part B later this year NEW YORK and LONDON, March 29, 2023 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, today announced regulatory authorities in Poland (Office for Registration of Medicinal Products, Medical Devices and Biocidal Products/URPL) and the U.K. (Medicines & Healthcare products Regulatory Agency/MHRA) have approved amendments to the company’s Investigational Medicinal Product Dossier (IMPD) and Clinical Trial Authorisation (CTA), respectively, for clinical use of the third-generation drug substance manufacturing process that increases the final
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News
- Akari Therapeutics, Plc (NASDAQ: AKTX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Akari Therapeutics, Plc (NASDAQ: AKTX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- Akari Therapeutics to Present PAS-Nomacopan Pre-Clinical Electroretinography (ERG) Data at ARVO 2024 [Yahoo! Finance]Yahoo! Finance
- Akari Therapeutics to Present PAS-Nomacopan Pre-Clinical Electroretinography (ERG) Data at ARVO 2024GlobeNewswire
- Akari Therapeutics, Plc (NASDAQ: AKTX) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
AKTX
Sec Filings
- 4/11/24 - Form 8-K
- 4/1/24 - Form 8-K
- 3/29/24 - Form 10-K
- AKTX's page on the SEC website