Pfizer and Myovant Obtain FDA Approval for MYFEMBREE

Pfizer Inc. (PFE) and Myovant Sciences (MYOV) announced that they have received the U.S. Food and Drug Administration’s (FDA) approval for MYFEMBREE. This is a first-of-its-kind daily treatment of up to 24 months, designed to manage heavy menstrual bleeding related to uterine fibroids in premenopausal women.

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The companies indicated that the U.S. regulator’s decision was based on data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies, which demonstrated the efficacy and safety of the treatment.

Per the terms of the prior collaboration agreement, Pfizer and Myovant will jointly commercialize MYFEMBREE in the U.S. The product is likely to be available this June.

Pfizer’s Internal Medicine Global President Nick Lagunowich said, “MYFEMBREE’s approval is a testament to the shared commitment between Myovant and Pfizer to support women living with uterine fibroids. We are excited to offer this new treatment option which will help provide much needed symptom relief with the convenience of an oral, once-daily tablet.” (See Pfizer stock analysis on TipRanks)

On May 12, Mizuho Securities analyst Vamil Divan downgraded Pfizer to Hold from Buy and maintained a price target of $42 (7.9% upside potential).

Currently, Divan believes that the company’s risk/reward is more balanced.

The analyst said, “Investor reaction has been mixed, with some agreeing it is difficult to find clear upside drivers after the stock’s recent run, while others believe the success Pfizer has seen with the COVID-19 vaccine (BNT162b2) bodes well for the company’s ability to improve R&D productivity and overcome upcoming patent losses, either directly through longer-term COVID-19 vaccine revenues, or by translating learnings from that remarkable success to other pipeline opportunities.”

Overall, the stock has a Hold consensus rating based on 10 Holds versus 1 Buy. The average analyst price target of $43.09 implies 10.7% upside potential from current levels. Shares have increased 9.8% over the past year.