De­lay­ing the in­evitable? Ax­some says FDA re­view go­ing be­yond PDU­FA date

The FDA was sup­posed to wrap up its re­view of Ax­some’s lead and po­ten­tial block­buster drug to treat ma­jor de­pres­sive dis­or­der on Sun­day.

In­stead, in a con­fer­ence call with the com­pa­ny on Sun­day, the reg­u­la­tor said that the re­view of AXS-05 would not be com­plet­ed by that ini­tial­ly agreed-to date.

“The FDA did not re­quest ad­di­tion­al in­for­ma­tion from the Com­pa­ny, and the re­view of the ap­pli­ca­tion is on­go­ing,” Ax­some said in a state­ment. The com­pa­ny did not im­me­di­ate­ly re­spond to a re­quest for com­ment on whether a CRL is com­ing. Ax­some shares $AXSM were up rough­ly 30% pre-mar­ket on Mon­day.

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