The future looked cloudy for Myovant Sciences and Pfizer's partnered endometriosis treatment on Tuesday, leading MYOV stock to collapse.
According to a news release, the Food and Drug Administration identified deficiencies in the companies' application for the drug, Myfembree, as a treatment for pain associated with endometriosis. Endometriosis is a painful complication in which tissue that normally lines the inside of the uterus grows outside it.
Myfembree is already approved to treat heavy menstrual bleeding tied to uterine fibroids. Myovant and Pfizer are angling for another approval for the once-daily pill.
On the stock market today, MYOV stock tumbled 25.1% to 10.39. Pfizer stock dipped 1.5% to 53.11.
MYOV Stock: Myfembree, A Sales Driver?
Myovant and Pfizer note the application is still under FDA review. But the issues prevent the agency and companies from discussing labeling and/or post-marketing requirements, the firms said.
"The FDA did not provide additional detail," they said. "The FDA noted that the letter does not reflect a final decision on the pending (application) and that the application is still under review."
The news sent Myovant shares below their 50-day moving average, according to MarketSmith.com. MYOV stock had retaken that key line in mid-March.
A second Myfembree approval would be a boon for Myovant, which has just one other marketed drug in the U.S. According to the National Institutes of Health, uterine fibroids occur in 20%-25% of reproductive-age women. Endometriosis occurs in 10%-15% of the same group.
MYOV stock analysts currently call for bullish sales growth over the next several years. This year, analysts surveyed by FactSet expect sales to surge more than 292%. By 2025, Myfembree is expected to account for nearly three-quarters of Myovant's sales.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
