By Colin Kellaher

 

Shares of Myovant Sciences Ltd. rose more than 15% in premarket trading Monday after the biopharmaceutical company and partner Pfizer Inc. won U.S. Food and Drug Administration expanded approval of Myfembree for the management of moderate to severe pain associated with endometriosis in premenopausal women.

The FDA had been slated to act on the application for expanded approval in early May but extended its review after the companies submitted more information regarding bone mineral density at the agency's request.

The agency last year approved Myfembree for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Myovant and Pfizer are jointly developing and commercializing Myfembree.

Myovant shares, which closed Friday at $15.12, were recently up at $17.50 in premarket trading.

 

Write to Colin Kellaher at colin.kellaher@wsj.com

 

(END) Dow Jones Newswires

August 08, 2022 06:38 ET (10:38 GMT)

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