FDA Concerns Cause OvaScience (OVAS) to Halt U.S. Trial of Souped-Up IVF Procedure; Stock Plunges -23.29% at Market Close (September 11, 2013)
9/11/2013 7:50:26 AM
Shares of OvaScience (NASDAQ: OVAS) were sent spiraling downward late Tuesday after the company revealed that the FDA wants it to seek regulatory approval for its lead product, Augment, a procedure designed to boost the success rate of in vitro fertilization. Cambridge, MA-based OvaScience received a letter from the FDA questioning the status of Augment as a human cellular tissue-based product, or HCT/P. Instead, the agency wants OvaScience to file an investigational new drug application.
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