[Updated, 9:15 am ET] 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.
When a product is designated as an HCT/P, it isn’t subject to the same regulatory scrutiny as a new chemical entity, which takes several years of clinical trials to win FDA approval. As a result of the letter, OvaScience has stopped enrolling patients in a trial testing Augment in the U.S., and will instead focus on continuing to ramp up study sites for an Augment trial outside of the U.S. that will begin next year.
Shares of OvaScience were down about 36 percent in pre-market trading Wednesday.
[Updated with comments from CEO] “This was not a final decision, nor did the FDA place our study on clinical hold,” OvaScience CEO Michelle Dipp said on a conference call with analysts on Wednesday. “We believe the FDA letter is largely based on preliminary information, and are very much looking forward to discussions with the FDA to provide details about Augment [and our] manufacturing procedures.”
Dipp said that OvaScience hasn’t yet met with the FDA to review Augment in detail, and that those talks will be key to figuring out the company’s clinical plans, future timelines, and budget moving forward. Dipp wouldn’t specify how long this would delay Augment’s path to the market, but did say that the company has been “preparing for this scenario” and has already begun the pre-IND studies that it believes the FDA will require. Still, OvaScience had been hoping to complete its U.S. trial and begin selling Augment here by the end of 2014.
Dipp said that OvaScience was “surprised” by the FDA letter given the company began the U.S. trial at the beginning of the year.
Augment is designed to upgrade the success rate of IVF by injecting mitochondria, the cell’s energy source, from egg precursor cells into older eggs outside the body, rejuvenating them and theoretically increasing the chance of pregnancy. It is OvaScience’s most advanced product.