ImmunoGen, Inc. (NASDAQ:IMGN) shares are trading flat at $3.57 after the company's Biologics License Application to treat ovarian cancer was accepted by the FDA with priority review.
ImmunoGen's BLA acceptance is for mirvetuximab soravtansine monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.
"FDA's acceptance of our BLA under Priority Review reinforces our belief in the potential for mirvetuximab soravtansine to serve as a new standard of care for patients with FRα-high platinum-resistant ovarian cancer," said Mark Enyedy, ImmunoGen's President and Chief Executive Officer.
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Immunogen is a clinical-stage biotechnology company.
According to data from Benzinga Pro, ImmunoGen has a 52-week high of $7.77 and a 52-week low of $3.37.
