Positive FDA Meeting Outlines Path Ahead for Akari Therapeutics’s Coversin in Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)
Akari Therapeutics Plc - American Depositary Shares (AKTX)
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Source: GlobeNewswire
HSCT-TMA trial in pediatric patients expected to start Q4 2019 following recent FDA feedback NEW YORK and LONDON, March 13, 2019 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and/or leukotriene systems are implicated, announces that it had a successful Type B, pre-IND meeting with the Food and Drug Administration (FDA) regarding Akari’s proposed pivotal clinical trial program for pediatric hematopoietic stem cell transplant-related thrombotic microangiopathy (HSCT-TMA). HSCT-TMA is an orphan condition with an estimated fatality rate of more than 80% in children with the severe disease.1 A framework for the trial design was agreed to with the FDA in which the response to Coversin of selected, clinically meaningful treatment variables would be the primary endpoint in the proposed pivotal trial. These responder endpoints were based on
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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 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
- Akari Therapeutics Insider Ups Holding By 69% During Year [Yahoo! Finance]Yahoo! Finance
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