Ax­some agrees to post-mar­ket­ing com­mit­ments with FDA, sig­nal­ing po­ten­tial OK for long-de­layed de­pres­sion drug

Ax­some Ther­a­peu­tics is like­ly on the cusp of its first drug ap­proval, send­ing shares of its stock up more than 40% pre-mar­ket on Tues­day.

The com­pa­ny said in an SEC fil­ing Tues­day that it has agreed to cer­tain post­mar­ket­ing re­quire­ments/com­mit­ments pro­posed by the FDA with re­spect to the com­pa­ny’s ap­pli­ca­tion for AXS-05 for the treat­ment of ma­jor de­pres­sive dis­or­der.

That ap­pli­ca­tion has been de­layed since Au­gust, with the com­pa­ny re­ceiv­ing a let­ter out­lin­ing how FDA-iden­ti­fied de­fi­cien­cies pre­clude la­bel­ing dis­cus­sions with Ax­some.

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