Cullinan Therapeutics (CGEM) Stock News

Cullinan Therapeutics (Nasdaq: CGEM) reported early velinotamig results showing reduced disease activity in patients with refractory systemic lupus erythematosus (SLE). Genrix Bio’s ongoing, open-label Phase 1b/2a study had treated 12 patients as of September 8, 2026. Among nine evaluable patients with at least four weeks of follow-up, eight achieved a reduction of at least four points on SLEDAI-2K, a disease-activity measure.

Among seven evaluable patients with baseline urine protein above 500 mg/24 hours, five had reduced proteinuria; four achieved complete renal responses, with urine protein below 500 mg/24 hours within 24 weeks. No dose-limiting toxicities, immune effector cell-associated neurotoxicity or Grade 3 or higher cytokine release syndrome occurred. Two patients had Grade 1 or 2 cytokine release syndrome, which resolved with standard management. Cullinan also has an ongoing global study in autoimmune blood disorders.

Cullinan Therapeutics (Nasdaq: CGEM) will present CLN-049 and velinotamig research at the ASH Annual Meeting on December 12–15, 2026. Four posters will cover clinical and preclinical work.

The CLN-049 Phase 1 abstract reports anti-leukemic activity at selected Phase 2 target doses of 6 µg/kg and 12 µg/kg in relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome. Cullinan describes a favorable safety profile with double step-up dosing; updated dose-escalation results will be presented. Other posters cover an ongoing CLN-049 combination trial in newly diagnosed leukemia, a velinotamig trial in two autoimmune blood disorders, and preclinical findings on targeting cells involved in those disorders.

Cullinan Therapeutics (Nasdaq: CGEM) received U.S. and Australian regulatory clearance to initiate a global Phase 1b/2a trial of velinotamig.

The open-label, multicenter study covers adults with relapsing and refractory immune thrombocytopenia (ITP) or warm autoimmune hemolytic anemia (wAIHA), disorders involving destruction of platelets or red blood cells. It will evaluate four doses injected under the skin. Part A tests ascending doses; Part B evaluates selected regimens in separate disease groups. Primary objectives assess safety, tolerability and effects on disease activity.

Velinotamig is designed to direct T cells against BCMA-expressing cells, including antibody-producing plasma cells. Genrix Bio will present autoimmune-disease clinical data on November 8, 2026; Cullinan expects updated results from the ongoing refractory systemic lupus erythematosus study to further inform this approach.

Cullinan Therapeutics (CGEM) and Taiho Oncology reported a 30.2% intracranial response rate with zipalertinib in the Phase 2 REZILIENT2 trial.

Cohort C studied advanced non-small cell lung cancer with EGFR exon 20 insertion or other uncommon EGFR mutations and active central nervous system metastases. Of 59 enrolled patients, 43 were evaluable for brain responses, including nine with disease involving the brain and spinal cord membranes. Median follow-up was 9.2 months. Intracranial disease control was 72.1%, and median brain-response duration was 9.7 months. Among 24 patients without prior EGFR inhibitor exposure, the intracranial response rate was 37.5%.

Grade 3 or higher treatment-related adverse events occurred in 20.9% of evaluable patients. Results will be presented at ESMO on October 26, 2026. Zipalertinib remains investigational and is not approved by any health authority.

Cullinan Therapeutics (CGEM) has dosed the first patient in its potentially registrational Phase 2 study of CLN-049 for relapsed/refractory acute myeloid leukemia.

The study evaluates the investigational treatment in patients whose leukemia has returned or resisted treatment after up to two prior therapy lines. Following an End-of-Phase 1 meeting with the U.S. FDA, it begins with dose optimization at two target dose levels, then advances to an expansion cohort without a comparison arm at the recommended Phase 2 dose. An exploratory cohort will evaluate patients with newly diagnosed TP53-mutated acute myeloid leukemia.

Cullinan expects a December update from the Phase 1 dose-escalation study in relapsed/refractory disease. In parallel, it is initiating a Phase 1/2 study of CLN-049 combined with azacitidine and venetoclax in newly diagnosed acute myeloid leukemia.

Cullinan Therapeutics (CGEM) initiated an FDA application submission for zipalertinib plus chemotherapy as a first-line treatment for a mutation-defined lung cancer. The application covers previously untreated, locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. Under Real-Time Oncology Review, clinical data can be reviewed before the complete application; Cullinan expects submission completion by year-end 2026.

The Phase 3 REZILIENT3 trial met its primary endpoint, showing a statistically significant improvement in median progression-free survival—time without disease worsening—versus chemotherapy alone. A separate application for zipalertinib monotherapy after platinum-based chemotherapy remains under FDA review, with a February 27, 2027 target action date. Cullinan is eligible for $30 million upon second-line U.S. approval and $100 million upon first-line U.S. approval.

Cullinan Therapeutics (CGEM) outlined fourth-quarter 2026 data updates for three investigational T cell engager programs on September 24, 2026.

In December, Cullinan plans to report multi-dose and single target dose regimen data for CLN-978 in systemic lupus erythematosus, rheumatoid arthritis and Sjögren’s disease. Multi-dose regimen data for velinotamig in lupus, from an ongoing Genrix Bio Phase 1 dose escalation study, are scheduled for a November 8 poster session at ACR Convergence 2026. Updated data from the dose escalation portion of the Phase 1 CLN-049 study in relapsed or refractory acute myeloid leukemia are planned for December. Cullinan also plans to initiate a potentially registrational Phase 2 study of CLN-049 following a recent FDA meeting.

Cullinan Therapeutics (CGEM) will participate in a fireside chat at the Stifel 2026 Virtual Immunology and Inflammation Forum on September 24, 2026, at 1:30 p.m. ET.

Chief Executive Officer Nadim Ahmed and Chief Medical Officer Jeffrey Jones will represent the company. A live webcast of the session will be accessible via the Events and Presentations section of Cullinan’s investor relations website. Cullinan is a clinical-stage biopharmaceutical company focused on developing potential first- or best-in-class, disease-modifying T cell engagers for autoimmune diseases and cancer, leveraging its expertise in T cell engagers that are established in oncology and extending them into autoimmune indications.

Cullinan Therapeutics (CGEM) will host a virtual event on Sept. 14, 2026 at 8:00 a.m. ET for analysts and institutional investors to discuss results from the planned interim analysis of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy, which were presented at the IASLC 2026 World Conference on Lung Cancer.

A live webcast and subsequent replay will be available via the events page of Cullinan Therapeutics’ investor relations website.