Acer Therapeutics Inc. said Tuesday it received a complete response letter (CRL) from the U.S. Food and Drug Administration regarding its new drug application (NDA) for Edsivo, a treatment of vascular Ehlers-Danlos syndrome (vEDS). After resuming trade following a halt for news, the stock plummeted 81% toward a record low in premarket trading. Volume of over 140,000 shares was already more than the full-day average of about 97,000 shares. The CRL says Acer will have to conduct an adequate and well-controlled trial to determine whether Edsivo (celiprolol) lowers the risk of clinical events in patients with vEDS. “We remain committed to working closely with the FDA to fully understand its response,” Acer Chief Executive Chris Schelling said in a statement. “We expect to respond to the FDA in the third quarter of this year.” The stock has lost 4.2% year to date through Monday, while the Dow Jones Industrial Average has gained 14.6%.Market Pulse Stories are Rapid-fire, short news bursts on stocks and markets as they move. Visit MarketWatch.com for more information on this news.
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