pdufa.bio

AUVELITY

Updated ยทnext FDA decision on the calendar

AUVELITY 1 FDA decision on record below. Every date links its source.

AXSM catalyst hub

About this program

We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Apr 30, 2026 ✓ ApprovedAXSM

Questions

When is AUVELITY's next FDA decision or readout?

No upcoming catalyst is on our calendar for AUVELITY; 1 FDA decision is on record below.

What happened at AUVELITY's most recent FDA decision?

On Apr 30, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.