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pdufa.bio

CLN-081

Updated ยทnext FDA decision on the calendar

CLN-081 is a Cullinan Therapeutics, Inc. program in Non Small Cell Lung Cancer. Its next catalyst is a Readout in Nov 2026. Every date links its source.

CGEM catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Indication under review: Non Small Cell Lung Cancer. Sponsor: Cullinan Therapeutics, Inc. (CGEM). Market-cap tier at the time we tracked it: Small. We track 3 catalyst events for this program: 2 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

Readout · Sep 2026CGEMReadout · Nov 2026CGEMPDUFA · Feb 27, 2027CGEM

Questions

When is CLN-081's next FDA decision or readout?

The next tracked catalyst for CLN-081 is a Readout in Nov 2026.

What happened at CLN-081's most recent FDA decision?

No FDA decision for CLN-081 is in our archive yet.

What is CLN-081 used for?

In our records CLN-081 is under review or in development for Non Small Cell Lung Cancer.

Who makes CLN-081?

Cullinan Therapeutics, Inc. (CGEM).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.