Axsome CEO Herriot Tabuteau (Photo by Owen Hoffmann/Patrick McMullan via Getty Images)

Ax­some ex­pects mi­graine drug to be re­ject­ed as man­u­fac­tur­ing is­sues arise

A New York-based bio­phar­ma com­pa­ny now ex­pects a re­jec­tion from the FDA for its po­ten­tial mi­graine drug as it’s fac­ing man­u­fac­tur­ing ques­tions.

Ax­some Ther­a­peu­tics, ac­cord­ing to an SEC fil­ing on Mon­day, was in­formed by the FDA that chem­istry, man­u­fac­tur­ing and con­trols (CMC) is­sues were iden­ti­fied dur­ing the FDA’s re­view of NDA for its mi­graine can­di­date known as AXS-07, set­ting up the an­tic­i­pat­ed CRL.

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