Cullinan Therapeutics, Inc.
CGEMNext catalyst
CLN-081
patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy
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Plus 2 more upcoming events in our data (conference, Phase 3 readout).See the timeline
3 upcoming, 1 past
Conference Presentation - CLN-049
For relapsed/refractory acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS); newly diagnosed AML (in combination with azacitidine and venetoclax). Cullinan Therapeutics announced four poster presentations at the 68th ASH Annual Meeting (Dec 12-15, 2026), including updated Phase 1 dose escalation data for CLN-049 in R/R AML/MDS and trials-in-progress and preclinical posters for CLN-049 and velinotamig. The abstract reports anti-leukemic activity at the selected Phase 2 doses and a favorable safety profile.
SourceFDA PDUFA Date CLN-081 (breakthrough)
For patients with locally advanced or metastatic EGFR ex20ins NSCLC who have previously received platinum-based chemotherapy. nda filing. Extracted from SEC filing: EX-99.1
SourcePhase 3 — zipalertinib
For cancer. Taiho Pharmaceutical and Cullinan Therapeutics' zipalertinib successfully completed a Phase 3 trial and is currently under FDA review with a decision expected by February 2027, positioning the asset for first-line cancer competition.
SourceUpcoming FDA decisions
Market Overview
Stock performance and key metrics
Frequently asked questions
What is in Cullinan Therapeutics, Inc.'s drug pipeline?→
CatalystAlert tracks 2 drug candidates in Cullinan Therapeutics, Inc.'s (CGEM) pipeline across Phase 2. Its lead program is CLN-081 (Phase 2). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Cullinan Therapeutics, Inc.'s next FDA catalyst?→
Cullinan Therapeutics, Inc.'s (CGEM) next tracked catalyst is a PDUFA date expected Feb 27, 2027. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track CGEM biotech catalysts?→
Add CGEM to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Cullinan Therapeutics, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.