Zipalertinib Plus Chemotherapy First-Line Phase 3 REZILIENT3 Trial Data Selected for Presidential Symposium Presentation at the IASLC 2026 World Conference on Lung Cancer

Cullinan Therapeutics (CGEM) shares rose 6.6% after positive Phase 3 trial results for zipalertinib in lung cancer. The trial met its primary endpoint, showing significant progression-free survival benefits. This positions zipalertinib as a potential first-line treatment for a specific subset of non-small cell lung cancer patients, supporting planned U.S. regulatory filings. Cullinan Therapeutics has no revenue but holds a high-risk pipeline with potential in oncology and autoimmune diseases.

Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics (CGEM) reported positive Phase 3 trial results for zipalertinib in lung cancer. The trial met its primary endpoint, showing significant improvement in progression-free survival for patients with EGFR exon 20 insertion mutations. The companies plan to submit full results for presentation at an upcoming medical conference and pursue U.S. regulatory approval. Zipalertinib would compete with Johnson & Johnson's amivantamab (Rybrevant) i

Cullinan Oncology (CGEM) shares rose about 6.4% pre-open after the company and partners reported REZILIENT3 Phase 3 results for zipalertinib plus platinum chemo in previously untreated EGFR exon 20 insertion NSCLC. The interim analysis met the primary endpoint with improved progression-free survival. The data supports U.S. first-line approval efforts, with up to $130M in milestones under the Cullinan-Taiho deal and a ~$334.5M cash balance.

Cullinan Therapeutics (Nasdaq: CGEM) reported Q2 2026 results and a corporate update. It said CLN-978 multi-dose data are planned for Q3 2026 (RA) and Q4 2026 (SLE), with Phase 2 expansions starting early 2027. CLN-049 Phase 2 in relapsed/refractory AML is planned for Q3 2026. Cash was $356.0M at June 30, 2026; net loss was $53.7M.

Cullinan Therapeutics, Inc. (CGEM) filed an SEC Form 8-K — Results of Operations and Financial Condition. Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results CLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027 Velinotamig (BCMA TCE) multi-dose regimen data in SLE in

Cullinan Therapeutics (NASDAQ:CGEM) shares rose 1.6% after the company reported positive FDA feedback from an End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 T cell engager for acute myeloid leukemia. The FDA discussed a Phase 2 plan, with a potentially registrational Phase 2 study starting in Q3 2026 and an update on dose escalation in Q4 2026.