ARCA Biopharma Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support Approval for the First Genetically-Targeted Cardiovascular Drug
ARCA biopharma, Inc. (ABIO)
US:NASDAQ Investor Relations:
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Source: GlobeNewswire
FDA Special Protocol Assessment agreement granted for PRECISION-AF clinical trial evaluating Gencaro as a potential treatment for atrial fibrillation in a heart failure population that has no FDA approved drug therapies58% treatment benefit seen versus active comparator in Phase 2B for planned Phase 3 target populationGencaro development program has FDA Fast Track designationU.S. and European cardiovascular patents and regulations may provide commercial exclusivity for Gencaro for 10 years post approval WESTMINSTER, Colo., Feb. 20, 2019 (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 reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a pivotal Phase 3 clinical trial, PRECISION-AF, to assess the safety and efficacy of GencaroT
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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
- SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates ANSS, HRT, CHX, ABIOPR Newswire
- SHAREHOLDER INVESTIGATION: The M&A Class Action Firm Announces an Investigation of ARCA Biopharma, Inc. - ABIOPR Newswire
- Abio Stock Alert: Halper Sadeh LLC Is Investigating Whether the Merger of Arca Biopharma, Inc. Is Fair to ShareholdersAccesswire
ABIO
Sec Filings
- 4/23/24 - Form 8-K
- 4/15/24 - Form SC
- 4/11/24 - Form SC
- ABIO's page on the SEC website