FDA on board with single Phase 3 to support marketing application for ARCA Bio's Gencaro; shares up 37% premarket [Seeking Alpha]
ARCA biopharma, Inc. (ABIO)
US:NASDAQ Investor Relations:
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Source: Seeking Alpha
FDA on board with single Phase 3 to support marketing application for ARCA Bio's Gencaro; shares up 37% premarketNano cap ARCA biopharma (NASDAQ:ABIO) is up37% premarket on robust volume in response to itsannouncement that the FDA has indicated that a single Phase 3 clinical trial may be sufficient to support a U.S. marketing application for Gencaro (bucindolol hydrochloride) for the treatment of atrial fibrillation in heart failure patients, a Fast Track-tagged indication.The company says it will launch the study when it secures additional financing.The news surprised the market considering the results from a Phase 2 study that failed to demonstrate a treatment benefit compared to TOPROL-XL (metoprolol succinate).Previously:ARCA bio down 18% after presentation of mid-stage data on Gencaro (May 29)See all stocks on the move »Now read:Ra Pharmaceuticals: Is Trying To Copy What Works A Good Product Development Strategy? »Subscribefor full text news in your inbox
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ABIO
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