Shares of ImmunoGen, Inc. IMGN, -31.27% fell 32% in premarket trade Wednesday after the company said the U.S. Food and Drug Administration recommended conducting a new Phase 3 trial of its ovarian cancer drug, mirvetuximab soravtansine. A recent trial looking at the drug as an ovarian cancer therapy did not meet its primary endpoint. ImmunoGen met with the FDA this past week to discuss the trial and a potential path forward, and the agency provided guidance on trial design and endpoints, the company said. “Our meeting with FDA enabled us to clarify a regulatory path forward for mirvetuximab and we are evaluating all avenues to bring this promising therapy to ovarian cancer patients,” Immunogen Chief Executive Mark Enyedy said in a statement. The Waltham, Mass.-based biotech has been working on mirvetuximab as a potential treatment for patients with ovarian cancer who haven’t responded to platinum treatment and who also test positive for high folate receptor α. Shares of the biotech have fallen 34% so far this year through Tuesday, while the S&P 500SPX, +0.21% has gained 13%.
Immunogen Inc. shares were trading at $2.20 per share on Wednesday morning, down $0.95 (-30.16%). Year-to-date, IMGN has declined -54.17%, versus a 14.27% rise in the benchmark S&P 500 index during the same period.
This article is brought to you courtesy of MarketWatch.