CGEM

CLN-978 (CD19 TCE) multi-dose regimen data in RA in Q3 2026 and SLE in Q4 2026; Phase 2 expansion studies to begin early 2027

CAMBRIDGE, Mass., July 28, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced positive feedback from the U.S. Food and Drug Administration (FDA) following an End-of-Phase 1 (EOP1) meeting for CLN-049, a FLT3xCD3 T cell engager being evaluated in patients with acute myeloid leukemia (AML).

Cullinan Therapeutics remains a compelling buy as zipalertinib approaches a key FDA decision for EGFR exon 20 insertion NSCLC. Zipalertinib demonstrates promising efficacy, including CNS activity and responses post-amivantamab, with pivotal phase 3 REZILIENT3 data expected later this year. CGEM's diversified pipeline in oncology and immunology, strong cash reserves, and operational runway into 2029 support continued optimism.

Cullinan Therapeutics, Inc. (CGEM) Discusses Promising Clinical Data for CLN-978 and Velinotamig in Autoimmune Diseases Transcript

New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies  Initial data from the first multi-dose cohort of RA study to be presented Initial data from the first multi-dose cohort of velinotamig study also to be shared Leading key opinion leaders Dr. Ricardo Grieshaber-Bouyer and Dr. John Tesser to share clinical perspectives The Company will host the in-person event for analysts and institutional investors on Wednesday, June 10, starting at 8:30 a.m. ET in New York City CAMBRIDGE, Mass.

Orphan Drug Designation underscores the potential of CLN-049, a novel FLT3xCD3 T cell engager, to address significant unmet need in AML

Initial clinical data in SLE and RA for CLN-978, a CD19 T cell engager, to be presented at the EULAR 2026 Congress in June; multi-dose regimen data in RA expected in Q3 2026  Zipalertinib NDA for relapsed EGFR ex20ins NSCLC accepted by U.S. FDA; PDUFA target action date of February 27, 2027 Cash and investments of $393.3 million as of March 31, 2026; runway into 2029 CAMBRIDGE, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today provided an update on recent and anticipated business highlights and announced its financial results for the first quarter ended March 31, 2026.

Cullinan Therapeutics's Zipalertinib NDA has been accepted, making its February 27, 2027, PDUFA date their clearest near-term catalyst. Zipalertinib targets EGFR exon 20 insertion NSCLC, a niche but still meaningful demographic that could expand over time with more trials for new indications. CGEM's CLN-978, Velinotamig, and CLN-049 add other interesting assets in their pipeline across autoimmune disease and AML.

PRINCETON, N.J. & TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed.