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CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases Sjögren's disease represents the third indication under development for CLN-978, and is a disease with high unmet need and no currently approved therapies CAMBRIDGE, Mass., April 29, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the Company is initiating a study of CLN-978 in patients with Sjögren's disease (SjD) in the U.S. The Company previously received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) Application clearance to study the CD19 T cell engager in patients with moderate to severe systemic lupus erythematosus (SLE) and European Medicines Agency (EMA) approval to study CLN-978 in active, difficult-to-treat rheumatoid arthritis.

Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate Cullinan and Taiho previously announced the Phase 2b portion of the study met the primary endpoint of overall response rate

Company-sponsored clinical trial will be initiated at FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore, Rome in Q2 2025

Initial clinical data from global Phase 1 study of CLN-978 in Systemic Lupus Erythematosus (SLE) expected in Q4 2025; CLN-978 remains the first and only development-stage CD19 T cell engager in an autoimmune disease clinical trial in the U.S. Zipalertinib pivotal Phase 2b study met primary endpoint; full results mid-year 2025 and NDA submission planned H2 2025, pending regulatory discussions Cash and investments of $606.9 million as of December 31, 2024, continues to provide runway into 2028 CAMBRIDGE, Mass., Feb. 27, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today reported recent and anticipated business highlights and announced its financial results for the fourth quarter and full year ended December 31, 2024.

CAMBRIDGE, Mass., Feb. 24, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its participation in the following upcoming investor conferences: Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D.

TOKYO, PRINCETON, N.J. and CAMBRIDGE, Mass.

Cullinan Therapeutics focuses on unaddressed or unmet needs in oncology and autoimmune conditions. In particular, Zipalertinib and CLN-978 stand out as its most promising product candidates. Zipalertinib targets a tiny niche in the large NSCLC market. Management expects to report its Phase 2b results by mid-2025. Similarly, CLN-978 is a first-in-class T-cell engager targeting SLE and RA. It can also potentially be expanded into other B-cell-mediated indications eventually.

Cullinan Therapeutics is a multifocal biotech with promising programs in precision medicine and immunotherapy, despite recent market sentiment declines. Zipalertinib shows potential in treating exon 20 insertion mutation-positive NSCLC, with a 40% objective response rate in early phase trials. CGEM has a strong financial position with cash reserves projected to fund operations into 2028, reducing the need for immediate equity raises.

CLN-978 is the first development stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases CAMBRIDGE, Mass., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) Application for CLN-978 and its global Phase 1 clinical trial may proceed in the U.S. to assess CLN-978 in patients with moderate to severe systemic lupus erythematosus (SLE).

Phase 1 clinical trial is designed to assess the safety, pharmacokinetics and initial clinical activity of CLN-978 for patients with systemic lupus erythematosus