Cullinan Therapeutics, Inc.
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- Cullinan Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing modality-agnostic targeted therapies for autoimmune diseases and cancer. The company’s product portfolio includes clinical-stage molecules such as CLN-619, CLN-978, zipalertinib (CLN-081/TAS6417), CLN-049, CLN-418, and CLN-617, which are designed to inhibit key drivers of disease or leverage the immune system to eliminate diseased cells. Zipalertinib, developed in collaboration with Taiho Oncology, Inc., targets genetically defined subsets of non-small cell lung cancer; CLN-049 is a novel FLT3xCD3 bispecific T cell engager for relapsed/refractory acute myeloid leukemia and recently received FDA Fast Track designation. Cullinan therapeutics also pursues CLN-978 specifically for autoimmune diseases, with systemic lupus erythematosus as a primary indication, reflecting a strategic expansion from oncology into immunology. The company operates primarily in the United States and through partnerships internationally, including Taiho Pharmaceutical in Greater China for commercialization outside the U.S. and China. Founded in 2016 and headquartered in Cambridge, Massachusetts, Cullinan recently changed its name from Cullinan Oncology to reflect its broadened autoimmune disease focus. Recent major developments include the initiation of a rolling submission for zipalertinib’s New Drug Application to the U.S. FDA, discontinuation of enrollment in its B-NHL study to focus on autoimmune diseases, a strategic partnership with Taiho Pharmaceutical for global commercialization rights of CLN-081/TAS6417, and financial positioning with cash resources supporting operations into 2029. The company emphasizes advancing first- or best-in-class therapies through clinical trials for high unmet medical needs in both autoimmune and oncologic therapeutic areas.
Company News
New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program
Cullinan Therapeutics: Compelling Pullback For CLN-978's Potential In Autoimmune Diseases
Cullinan Therapeutics Eyes December Data Catalyst for CLN-978 and CLN-049
Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio
Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum
Engineers Gate Manager LP Increases Stock Position in Cullinan Therapeutics, Inc. $CGEM
Cullinan Therapeutics, Inc. (CGEM) Shareholder/Analyst Call Transcript
Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer
Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median Progression-Free Survival Benefit in REZILIENT3 Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation Non-Small Cell Lung Cancer
Cullinan Therapeutics to Host Virtual Analyst and Investor Event to Showcase Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer
Cullinan Therapeutics: A Self-Funding Bridge To Immune Reset
Bank of America Corp DE Acquires 170,417 Shares of Cullinan Therapeutics, Inc. $CGEM
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 Zipalertinib Combo Clears Key Phase 3 Hurdle As First-Line Lung Cancer Treatment Option Takes Shape
Cullinan Therapeutics Provides Corporate Update and Reports Second Quarter 2026 Financial Results
Cullinan Therapeutics Announces Positive End-of-Phase 1 Meeting with FDA for CLN-049 and Advances Program to a Potentially Registrational Phase 2 Study in AML
Cullinan Therapeutics: Heading Toward Paydirt
Cullinan Therapeutics, Inc. (CGEM) Discusses Promising Clinical Data for CLN-978 and Velinotamig in Autoimmune Diseases Transcript
Cullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune Diseases