Cullinan Therapeutics, Inc. (CGEM) Starts NDA for Zipalertinib Combo Under FDA RTOR

Cullinan Therapeutics (CGEM) submitted a New Drug Application to the FDA for zipalertinib in combination with chemotherapy to treat a specific type of lung cancer. The submission is under the FDA's Real-Time Oncology Review program and is supported by positive Phase 3 trial data showing improved progression-free survival. The company expects to complete the submission by the end of 2026. CGEM's stock closed at $14.53, down 5.34%.

Cullinan Therapeutics (CGEM) initiated an FDA filing for zipalertinib, a lung cancer drug, in combination with chemotherapy. The Phase 3 trial met its primary endpoint, showing improved progression-free survival. The company expects to complete the NDA submission by year-end 2026 and could receive $130 million in milestones upon approvals. Zipalertinib is being developed with Taiho Oncology and Taiho Pharmaceutical.

Cullinan Therapeutics (CGEM) initiated NDA submission for zipalertinib plus chemotherapy in first-line EGFR exon20ins NSCLC under FDA's RTOR program, with completion expected by year-end 2026. The submission follows positive Phase 3 REZILIENT3 trial results, showing significant improvement in progression-free survival. Zipalertinib has FDA Breakthrough Therapy designation, and Cullinan may receive $100M in milestone payments upon approval.

Cullinan Therapeutics (CGEM) shares fell 5% after delaying rheumatoid arthritis data to December, later than expected. The company also faces safety concerns about zipalertinib. Cullinan plans to present data on other drugs at upcoming conferences. TD Cowen maintains a Buy rating, citing potential catalysts. CGEM stock is up 55% year-to-date.

Cullinan Therapeutics (CGEM) reported Phase 3 REZILIENT3 results, showing zipalertinib plus chemotherapy achieved 14.5 months median PFS vs. 8.5 months for chemotherapy alone in NSCLC patients. While efficacy is promising, high adverse event rates raise toxicity concerns. The company shares U.S. profits with Taiho Pharmaceutical.

Cullinan Therapeutics (CGEM) shares fell 6.3% despite positive Phase 3 trial results for zipalertinib in lung cancer treatment. The REZILIENT3 trial met its primary endpoint, showing a 6.0-month improvement in median progression-free survival compared to chemotherapy alone. The company plans to discuss the results with health authorities. According to Cullinan, the trial enrolled 279 patients with advanced NSCLC.