Zipalertinib (CLN-081) is a Cullinan Therapeutics, Inc. program in relapsed EGFR exon 20 insertion non-small cell lung cancer. Its PDUFA date is Feb 27, 2027, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: Relapsed EGFR exon 20 insertion non-small cell lung cancer. Sponsor: Cullinan Therapeutics, Inc. (CGEM). Market-cap tier at the time we tracked it: Small. We track 1 catalyst event for this program: 1 upcoming and 0 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| BVF Inc. | 5,750,683 | $104.7 million | filed August 14, 2026 |
| RTW Investments | 2,364,347 | $43.1 million | filed August 14, 2026 |
| Perceptive Advisors | 426,478 | $7.8 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
Zipalertinib (CLN-081)'s PDUFA date is Feb 27, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for Zipalertinib (CLN-081) is in our archive yet.
In our records Zipalertinib (CLN-081) is under review or in development for Relapsed EGFR exon 20 insertion non-small cell lung cancer.
Cullinan Therapeutics, Inc. (CGEM).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.