UPDATE 2-ARCA gets fast-track status for heart drug, shares soar
* Expects to submit study protocol for review in Q4
* Shares jump 81 pct (Updates stock movement)
Nov 23 (Reuters) - ARCA biopharma Inc (ABIO.O) said U.S. health regulators granted a fast-track designation for its experimental drug, Gencaro, to treat chronic heart failure, sending its shares up as much as 81 percent.
The company said it expects to submit a study protocol for review under the U.S. Food and Drug Administration's special protocol assessment (SPA) process in the fourth quarter of 2009.
ARCA expects to begin the proposed trial in late 2010 or the first half of 2011.
Fast-track status is designed to expedite the review of drugs to treat serious diseases and fill unmet medical needs.
ARCA shares were up 76 percent at $3.95 in midday trade and were one of the largest percentage gainers on Nasdaq Monday. They touched a high of $4.08 earlier in the session. (Reporting by Shailesh Kuber in Bangalore; Editing by Vinu Pilakkott and Gopakumar Warrier) ((shailesh.kuber@thomsonreuters.com; within U.S. +1 646 223 8780; outside U.S. +91 80 4135 5800; Reuters Messaging: shailesh.kuber.reuters.com@reuters.net))
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