CGEM PDUFA Date: Zipalertinib Page updated November 5, 2026 · next FDA decision on the calendar · Data as of Nov 5, 2026 5:03 AM ET FDA decision (PDUFA) target Feb 27, 2027 · Cullinan Therapeutics, Inc. · Relapsed EGFR exon 20 insertion non-small cell lung cancer
Key facts FDA PDUFA target date 2027-02-27
Drug / candidate Zipalertinib (CLN-081)
Indication Relapsed EGFR exon 20 insertion non-small cell lung cancer
Company Cullinan Therapeutics, Inc.
Market-cap tier Small
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See every 2027 PDUFA date → All February 2027 PDUFA dates → FAQ When is the CGEM PDUFA date? The FDA PDUFA target date for CGEM (Cullinan Therapeutics, Inc.) is 2027-02-27 for Zipalertinib (CLN-081). Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is CGEM's drug Zipalertinib? Zipalertinib (CLN-081) is Cullinan Therapeutics, Inc.'s candidate under FDA review for Relapsed EGFR exon 20 insertion non-small cell lung cancer.
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