Myovant Sciences Ltd (NYSE:MYOV) shares are trading significantly lower Tuesday after the company and Pfizer Inc (NYSE:PFE) announced an update on the Supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis.
In accordance with the ongoing review of the application, on April 6, the FDA provided notice to the companies that it identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitments.
The FDA did not provide additional details, but the administration noted that the letter does not reflect a final decision on the pending sNDA and that the application is still under review.
Myovant and Pfizer said they plan to continue to work with the FDA to determine the next steps in the application process.
MYFEMBREE is an oral treatment for heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
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MYOV Price Action: Myovant has traded as high as $27.43 over a 52-week period. It's making new 52-week lows Tuesday.
According to Benzinga Pro data, the stock was down 20.8% at $10.98 at press time.
Photo: AhmadArdity from Pixabay.
