Why Myovant Sciences Stock Is Crashing Today

Shares of Myovant Sciences (NYSE: MYOV) had crashed by 23.4% as of 11 a.m. ET on Tuesday. The steep decline came after the company and its partner, Pfizer (NYSE: PFE), announced that the Food and Drug Administration (FDA) had identified deficiencies in the Supplemental New Drug Application (sNDA) for Myfembree in managing moderate-to-severe endometriosis pain.

The FDA had previously established a PDUFA date of May 6 to complete its review of the sNDA for Myfembree. This issue may set the schedule back, but the regulator stated in its letter to Myovant and Pfizer that it hasn't made a final decision on the supplemental approval.

Investors reacted so negatively to the news because Myovant was counting on a May U.S. launch of Myfembree in the endometriosis indication. The FDA approved the drug as a treatment for heavy menstrual bleeding associated with uterine fibroids in May 2021.

Source Fool.com