Myovant and Pfizer’s path to securing a second nod for Myfembree gets hazy — and investors react quickly
Myovant was on tap for a May 6 decision on a supplemental NDA for its three-in-one pill Myfembree, aiming to treat moderate to severe pain associated with endometriosis. With an FDA nod, Myovant would get a $100 million regulatory milestone from partner Pfizer.
But the path for Myfembree’s second approval became a little clouded Tuesday, as the Roivant descendant said the FDA “identified deficiencies that preclude discussion of labeling and/or post-marketing requirements and commitment at this time.”
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