IMGN ImmunoGen Inc

By Chris Wack

ImmunoGen Inc. shares were up 96% to $10.20 in premarket trading after the company said it saw positive top-line data from a Phase 3 trial evaluating the safety and efficacy of Elahere mirvetuximab soravtansine-gynx.

The company said the trial compared patients who received Elahere, with chemotherapy in patients with folate receptor alpha-positive platinum-resistant ovarian cancer who have received one to three prior lines of therapy.

Based on this data, the company said it plans to submit a Marketing Authorization Application in Europe and a supplemental Biologics License Application in the U.S. for the conversion to a regular approval of Elahere.

ImmunoGen said the safety profile of Elahere consists predominantly of low-grade ocular and gastrointestinal events.

In November 2022, the U.S. Food and Drug Administration granted accelerated approval for Elahere for the treatment of adult patients with receptor alpha-positive platinum-resistant ovarian cancer, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

ImmunoGen plans to submit an MAA to the European Medicines Agency and an sBLA to the FDA in the second half of this year.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

May 03, 2023 08:46 ET (12:46 GMT)

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