Myovant Sciences Stock Hits 52-Week Low After FDA Notice for Myfembree

By Chris Wack

Myovant Sciences Ltd. shares slumped 25% to $10.45 after the company said it received a notice of deficiency for its supplemental New Drug Application with Pfizer Inc. for Myfembree for the management of moderate to severe pain associated with endometriosis.

The stock hit its 52-week low of $10.30 earlier in the session. The stock is down 33% year to date.

In accordance with the ongoing review of the application, the U.S. Food and Drug Administration provided notice to the companies that the agency identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments at this time.

The FDA didn't provide additional details, but noted that the letter doesn't reflect a final decision on the pending sNDA and that the application is still under review.

Myovant and Pfizer will continue to work with the FDA to determine next steps with the application.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

04-12-22 1316ET