My­ovan­t's Myfem­bree sN­DA gets new PDU­FA af­ter CRL spec­u­la­tion; In­xMed bags more funds for piv­otal stud­ies

Last month, an­a­lysts spec­u­lat­ed the sN­DA for My­ovant Sci­ences and Pfiz­er’s Myfem­bree could be hit by a CRL af­ter the FDA iden­ti­fied “de­fi­cien­cies.” Now, the com­pa­nies are say­ing the drug de­ci­sion da­ta has been pushed back.

The Swiss biotech said Fri­day that the PDU­FA date was pushed from May 6 to Aug. 6, and Cowen an­a­lysts re­act­ed pos­i­tive­ly.

“This is an en­cour­ag­ing de­vel­op­ment. Fol­low­ing the dis­clo­sure of de­fi­cien­cies, we had ex­pect­ed a CRL to­day, but the ex­ten­sion sug­gests a path to ap­proval this sum­mer. We con­tin­ue to be­lieve MY­OV is un­der­val­ued for the re­l­u­golix fran­chise,” Cowen an­a­lysts wrote in a note.

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