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FDA on board with single Phase 3 to support marketing application for ARCA Bio's Gencaro; shares up 37% premarket

Published 07/31/2018, 09:11 AM
© Reuters.  FDA on board with single Phase 3 to support marketing application for ARCA Bio's Gencaro; shares up 37% premarket
ABIO
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  • Nano cap ARCA biopharma (NASDAQ:ABIO) is up 37% premarket on robust volume in response to its announcement 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)
  • Now read: Ra Pharmaceuticals: Is Trying To Copy What Works A Good Product Development Strategy?


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