Cullinan Therapeutics, Inc.

0 products tracked · names used in filings: Cullinan Therapeutics, Inc.

Upcoming milestones

Sat 27 Feb 2027🇺🇸 PDUFA datecompany-announcedin 105 days

Zipalertinib: PDUFA target action date (EGFR exon 20 insertion NSCLC previously treated with platinum-based chemotherapy (accelerated approval, monotherapy))

Cullinan Therapeutics, Inc. (CGEM); zipalertinib; NDA; status: set; "An NDA seeking accelerated approval for zipalertinib monotherapy in this indication remains under FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date of February 27, 2027."; filed 2026-10-02 · source

Recent milestones

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Products

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.