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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