pdufa.bio

Source-verified

Updated ยทnext FDA decision on the calendar

Source-verified 20 FDA decisions on record below. Every date links its source.

ALDX catalyst hub · ALLO catalyst hub · ATRA catalyst hub · CAPR catalyst hub · ENGN catalyst hub · EQ catalyst hub · ESLA catalyst hub · IBRX catalyst hub · JSPR catalyst hub · LSTA catalyst hub · MIST catalyst hub · OTLK catalyst hub · PHAR catalyst hub · PHIO catalyst hub · REPL catalyst hub · SNSE catalyst hub · SVRA catalyst hub · TRAW catalyst hub · UNCY catalyst hub

About this program

We track 20 catalyst events for this program: 0 upcoming and 20 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 · Jan 8, 2025 CRLJSPRPDUFA · Jan 13, 2025 CRLPHIOPDUFA · Jan 16, 2025 CRLATRAPDUFA · Jan 22, 2025 CRLLSTAPDUFA · Feb 14, 2025 CRLALLOPDUFA · Mar 27, 2025 CRLEQPDUFA · Mar 28, 2025 CRLMISTPDUFA · Apr 3, 2025 CRLALDXPDUFA · May 27, 2025 CRLSVRAPDUFA · Jun 3, 2025 CRLTRAWPDUFA · Jun 30, 2025 CRLUNCYPDUFA · Jul 7, 2025 CRLJSPRPDUFA · Jul 11, 2025 CRLCAPRPDUFA · Jul 22, 2025 CRLREPLPDUFA · Aug 28, 2025 CRLOTLKPDUFA · Oct 17, 2025 CRLSNSEPDUFA · Nov 3, 2025 CRLESLAPDUFA · Nov 11, 2025 CRLENGNPDUFA · Jan 16, 2026 CRLIBRXPDUFA · Feb 1, 2026 CRLPHAR

Questions

When is Source-verified's next FDA decision or readout?

No upcoming catalyst is on our calendar for Source-verified; 20 FDA decisions are on record below.

What happened at Source-verified's most recent FDA decision?

On Feb 1, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.