Dave Marek, Myovant CEO

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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