ARCA biopharma Updates Special Protocol Assessment Request to FDA for Gencaro Phase 3 Atrial Fibrillation Clinical Trial
ARCA biopharma, Inc. (ABIO)
US:NASDAQ Investor Relations:
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Source: GlobeNewswire
Phase 3 atrial fibrillation trial planned in population with no effective or FDA approved therapiesPRECISION-AF, planned Phase 3 clinical trial in patients with genotype that responds most favorably to Gencaro WESTMINSTER, Colo., Dec. 20, 2018 (GLOBE NEWSWIRE) -- ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that it has submitted an amendment to its Special Protocol Assessment (SPA) request to the U.S. Food and Drug Administration (FDA). The amendment addresses FDA feedback and guidance on the target population for ARCA’s planned Phase 3 clinical trial. The SPA request is part of the Company’s ongoing interaction with the FDA focused on the planned Phase 3 clinical development program of GencaroTM (bucindolol hydrochloride) as a genetically-targeted treatment for atrial fibrillation (AF) in patients with heart failure (HF). T
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News
- ARCA biopharma, Inc. (NASDAQ: ABIO) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
- ARCA biopharma, Inc. (NASDAQ: ABIO) is now covered by analysts at StockNews.com. They set a "sell" rating on the stock.MarketBeat
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- Abio Stock Alert: Halper Sadeh LLC Is Investigating Whether the Merger of Arca Biopharma, Inc. Is Fair to ShareholdersAccesswire
ABIO
Sec Filings
- 4/15/24 - Form SC
- 4/11/24 - Form SC
- 4/9/24 - Form SC
- ABIO's page on the SEC website