Cullinan Therapeutics announced the initiation of a New Drug Application (NDA) submission to the FDA for zipalertinib in combination with platinum-based chemotherapy for treating previously untreated EGFR exon 20 insertion NSCLC. The Phase 3 REZILIENT3 trial met its primary endpoint, demonstrating statistically significant improvement in median progression-free survival. The NDA submission is expected to be completed by year-end 2026 under the FDA's Real-Time Oncology Review program.

Cullinan Therapeutics announced that its CEO Nadim Ahmed and Chief Medical Officer Jeffrey Jones will participate in a fireside chat at the Stifel 2026 Virtual Immunology and Inflammation Forum on September 24, 2026. The company is a clinical-stage biopharmaceutical firm developing disease-modifying T cell engagers for autoimmune diseases and cancer.

Cullinan Therapeutics announced it will host a virtual event on September 14, 2026, to discuss Phase 3 REZILIENT3 trial results for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion mutation NSCLC. The trial met its primary endpoint of progression-free survival at the planned interim analysis, with results to be presented at the IASLC 2026 World Conference on Lung Cancer.

Cullinan Therapeutics announced positive Phase 1 clinical data for CLN-978, a CD19xCD3 T cell engager, showing clinical benefit including remissions in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients following single target doses. The drug demonstrated deep, dose-dependent B cell depletion with a favorable safety profile. The company will present additional data and host an Immunology Day on June 10 to discuss CLN-978 and initial data for velinotamig, a BCMAxCD3 T cell engager.

Cullinan Therapeutics announced that initial clinical data from Phase 1 studies of CLN-978, a CD19xCD3 T cell engager, will be presented at EULAR 2026 Congress in June. The data shows favorable safety profiles, robust B cell depletion, and early promising clinical activity in patients with treatment-refractory rheumatoid arthritis and systemic lupus erythematosus.

Cullinan Therapeutics presented preclinical data for CLN-978, a novel CD19xCD3 bispecific T cell engager, demonstrating potential for B cell depletion across multiple autoimmune diseases like rheumatoid arthritis, Sjögren's disease, and systemic lupus erythematosus.

Cullinan Therapeutics will participate in a fireside chat at the Stifel 2025 Virtual Immunology and Inflammation Forum, presenting insights into their clinical-stage therapeutic assets targeting autoimmune diseases and cancer.

Cullinan Therapeutics announced ongoing clinical trials for CLN-978 and velinotamig in autoimmune diseases, shared zipalertinib oncology results, and appointed two new board members while maintaining a strong cash position of $510.9 million.

Cullinan Therapeutics received approval from the European Medicines Agency to initiate a Phase 1 trial of its bispecific CD19 T cell engager CLN-978 in patients with rheumatoid arthritis. The trial will be conducted at research institutions in Germany and Italy, and CLN-978 is also being studied for systemic lupus erythematosus.

Cullinan Therapeutics reported progress in its pipeline, including initial clinical data for CLN-978 in Systemic Lupus Erythematosus expected in Q4 2025 and positive results from the pivotal Phase 2b study of zipalertinib. The company ended 2024 with $606.9 million in cash, providing runway into 2028.

Cullinan Therapeutics will present new preclinical data for its CD19-directed T cell engager CLN-978 at the ACR Convergence 2024 conference. The data show CLN-978 induced similar T cell activation, target B cell depletion, and cytokine production in cells from patients with SLE or RA as compared to healthy volunteers, suggesting a broad therapeutic potential. Cullinan plans to initiate a global Phase 1b study of CLN-978 in patients with moderate to severe SLE.

Amgen's rocatinlimab outperformed placebo in an atopic dermatitis trial, but the data fell short of market leader Dupixent's results, raising concerns about its competitiveness. Uplizna, Amgen's treatment for myasthenia gravis, showed promising results in a Phase 3 trial, with potential advantages like less frequent dosing.