Fol­low­ing an al­most year­long wait, FDA ap­proves Ax­some's rapid-act­ing de­pres­sion drug

Af­ter a near­ly 365-day de­lay, Ax­some Ther­a­peu­tics has se­cured its first drug ap­proval with an FDA green light for Au­veli­ty as a treat­ment for adults with ma­jor de­pres­sive dis­or­der.

The biotech is keep­ing shy on the pric­ing for now and, on an in­vestor call, CEO Her­riot Tabuteau at­trib­uted the FDA’s year­long de­lay main­ly to the Covid-19 pan­dem­ic. The rapid-act­ing NM­DA re­cep­tor an­tag­o­nist is not a sched­uled drug un­der the DEA, the CEO con­firmed on the call.

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