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Recent Updates — CGEM

September 14, 2026View Source ↗

Cullinan Therapeutics, Inc., in collaboration with Taiho Oncology and Taiho Pharmaceutical, announced positive Phase 3 REZILIENT3 trial results for zipalertinib plus chemotherapy versus chemotherapy alone in first-line EGFR exon 20 insertion mutation-positive non-small cell lung cancer. The combination therapy demonstrated a statistically significant progression-free survival benefit of 14.5 months compared to 8.5 months (hazard ratio 0.50; P=0.00015). Objective response rates were higher for the combination arm at 65.0% versus 40.3%. The filing does not contain a stock split or dividend announcement. Cullinan Therapeutics operates in the biopharmaceutical industry, developing T cell engagers for autoimmune diseases and cancer.

August 12, 2026View Source ↗

Cullinan Therapeutics, Inc., in collaboration with Taiho Oncology and Taiho Pharmaceutical, announced that its global Phase 3 REZILIENT3 clinical trial met its primary endpoint of progression-free survival (PFS) at a planned interim analysis. The study evaluated the combination of zipalertinib and platinum-based chemotherapy versus chemotherapy alone for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR exon 20 insertion mutations. The trial enrolled 285 adults and demonstrated statistically significant and clinically meaningful improvement in PFS with a manageable safety profile, prompting the Independent Data Monitoring Committee to recommend unblinding. Cullinan and Taiho plan to pursue U.S. regulatory approval for this combination regimen pending discussions with the FDA. Cullinan Therapeutics is a biopharmaceutical company developing potential first- or best-in-class disease-modifying T cell engagers for autoimmune diseases and cancer.

August 6, 2026View Source ↗

Cullinan Therapeutics reported financial results for the second quarter ended June 30, 2026, posting a net loss of $53.7 million compared to $70.1 million in the prior year period. Research and development expenses decreased to $44.4 million from $61.0 million, while general and administrative expenses fell to $12.8 million from $14.8 million. The company held cash and investments of $356 million as of June 30, 2026, providing a runway into 2029 under its current operating plan. Clinically, the company plans to share multi-dose regimen data for CLN-978 in rheumatoid arthritis (Q3 2026) and systemic lupus erythematosus (Q4 2026), with Phase 2 expansion studies beginning early 2027. Velinotamig multi-dose data is expected in Q4 2026, followed by a Phase 1/2 basket study in autoimmune cytopenias starting early 2027. Additionally, Cullinan will initiate a potentially registrational Phase 2 study for CLN-049 in relapsed or refractory acute myeloid leukemia in Q3 2026 following a positive FDA End-of-Phase 1 meeting. The company operates as a clinical-stage biopharmaceutical firm developing T cell engagers for autoimmune diseases and cancer.

June 10, 2026View Source ↗

Cullinan Therapeutics, Inc. announced updated Phase 1 OUTRACE clinical trial data for CLN-978 in patients with rheumatoid arthritis and systemic lupus erythematosus. In the rheumatoid arthritis cohort, a patient achieved DAS28-ESR remission at week eight. The company also shared initial Phase 1b/2a data for velinotamig in China, where two patients achieved complete renal response and significant reductions in SLEDAI-2K scores. Cullinan Therapeutics, Inc. is a biotechnology company focused on developing immunology-related therapies.

June 8, 2026View Source ↗

Cullinan Therapeutics, Inc. announced initial Phase 1 OUTRACE clinical trial data for CLN-978 in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The data showed significant B cell depletion and improvements in disease activity markers for both conditions, though a single case of Grade 3 cytokine release syndrome (CRS) was reported in the 45 <mu>g target dose cohort.