pdufa.bio

CRL for

Updated ยทnext FDA decision on the calendar

CRL for 3 FDA decisions on record below. Every date links its source.

ACHV catalyst hub · LNTH catalyst hub · UNCY catalyst hub

About this program

We track 3 catalyst events for this program: 0 upcoming and 3 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 · Jun 20, 2026 CRLACHVPDUFA · Jun 29, 2026 CRLLNTHPDUFA · Jun 29, 2026 CRLUNCY

Questions

When is CRL for's next FDA decision or readout?

No upcoming catalyst is on our calendar for CRL for; 3 FDA decisions are on record below.

What happened at CRL for's most recent FDA decision?

On Jun 29, 2026 the FDA issued a Complete Response Letter. The decision page carries the source document and the measured share-price reaction.