OvaScience Inc is a life science company developing proprietary products to improve the treatment of female infertility based on recent scientific discoveries about the existence of egg precursor cells.
Osiris Therapeutics (OSIR -2.2%) is weaker in early trading.
Perhaps weighing on the shares is the news out of OvaScience (OVAS -30.6%) that the FDA is questioning AUGMENT's status as a 361 HCT/P.
This is the second time this month that the regulator has raised HCT/P questions — MiMedx (MDXG +1.5%) suffered a nasty sell-off last week after the FDA said Amnion / Chorion Injectable products weren't regulated solely under section 361. (letter) The company claimed to have considered the issue closed after the Center for Biologics Evaluation and Research classified a 2012 plant inspection as "NAI".
OSIR's Grafix and Ovation are HCT/P products and some question whether the company will face regulatory scrutiny going forward.
For those interested, here's what the FDA has to say about HCT/Ps: Guidance
OvaScience (OVAS) shares plummet 38% after the FDA said the company has to file an Investigational New Drug application for its lead product, Augment, which is designed to increase IVF success rates.
The FDA has doubts about the status of Augment as a human cellular tissue-based product (HCT/P), which isn't subject to the same scrutiny as a new chemical entity and so can avoid years of trials to gain FDA authorization.
OvaScience has halted a U.S. study of Augment and will focus on trials outside the country, which are slated to start in 2014.
The company plans to hold talks with the FDA but its hopes of launching the treatment in the U.S. by the end of next year are looking rather forlorn. (PR)