FDA pushes back review date for Myovant and Pfizer's Myfembree sNDA

9 May 2022

Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) on Friday announced today that the US Food and Drug Administration has extended the review period for the supplemental New Drug Application (sNDA) for Myfembree (relugolix 40mg, estradiol 1mg, and norethindrone acetate 0.5mg) for the management of moderate to severe pain associated with endometriosis.

The FDA requires extended time to review additional information the Agency requested from the companies regarding bone mineral density. The extended Prescription Drug User Fee Act (PDUFA) goal date is August 6, 2022.

Switzerland-based Myovant saw its shares close down 3.6% at $8.68, having dropped as low as $8.40, on Friday.

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