News & Events zu Cullinan Therapeutics Inc (CGEM)CGEMCullinan Therapeutics Inc

Cullinan Therapeutics Doses First Patient in Phase 2 Study of CLN-049

Cullinan Therapeutics announced that the first patient has been dosed in its Phase 2 study of CLN-049, an investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia, or AML. In parallel, the company is initiating a Phase 1/2 study evaluating the combination of CLN-049, azacitidine, and venetoclax in patients with newly diagnosed AML.

Cullinan Therapeutics Submits NDA for Non-Small Cell Lung Cancer Treatment

The company stated: "Cullinan Therapeutics announced the initiation of a New Drug Application submission to the U.S. Food and Drug Administration for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion (ex20ins) mutations under the FDA's Real-Time Oncology Review program. The RTOR program allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. Completion of the NDA submission is expected by year-end 2026. The NDA submission is based on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone. These results were recently presented at the International Association for the Study of Lung Cancer's 2026 World Conference on Lung Cancer during a Presidential Symposium, where potentially practice-changing clinical data are highlighted."

Cullinan Therapeutics Enters Q4 with Catalyst-Rich Roadmap

Cullinan Therapeutics enters Q4 with a catalyst-rich roadmap across its autoimmune and AML programs, as longer follow-up and multi-dose data for '978 in SLE, RA, and SjD could help shape Phase 2 plans, while durability updates for '049 in r/r AML could strengthen its competitive profile and support pivotal development, TD Cowen tells investors in a research note. The firm, which has a Buy rating on the shares, sees a buying opportunity following recent weakness ahead of the Q4 events.