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Cullinan Advances Zipalertinib NDA for EGFR Exon 20 NSCLC Under RTOR

Oct 1, 2026, 7:41 PM EDT1 sourcesAI-analyzed

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Positive regulatory trajectory, milestone upside, and supportive trial data could lift CGEM shares ahead of 2027 milestones.

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Cullinan Therapeutics announced an NDA submission for zipalertinib with platinum chemotherapy under the FDA RTOR program for EGFR ex20ins NSCLC, targeting completion by year-end 2026. Phase 3 REZILIENT3 showed a meaningful PFS improvement, supporting potential first-line use and ongoing monotherapy review with a February 2027 PDUFA target.

NDA submission for zipalertinib with platinum chemo under RTOR; completion by 12/31/2026.
REZILIENT3 met primary endpoint; median PFS improved versus chemo.
WCLC 2026 Presidential Symposium data presented for zipalertinib.
Milestones: $30M second-line, $100M first-line U.S. approvals.

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Cullinan Advances Zipalertinib NDA for EGFR Exon 20 NSCLC Under RTOR

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