Cullinan Therapeutics, Inc. - Common Stock (CGEM)

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

CAMBRIDGE, Mass., May 18, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that initial clinical data from two ongoing Phase 1 studies evaluating CLN-978, a subcutaneously administered CD19xCD3 T cell engager, will be presented at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology being held June 3-6, 2026 in London, United Kingdom.

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 

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 on or after platinum-based chemotherapy, with or without amivantamab. The Prescription Drug User Fee Act (PDUFA) target action date is February 27, 2027.

Initial clinical data for CLN-978 in SLE and RA confirmed for Q2 2026; repeat dosing data in RA confirmed for Q3 2026

CAMBRIDGE, Mass., Feb. 24, 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 announced its participation in the following upcoming investor conferences:

CAMBRIDGE, Mass., Feb. 18, 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 announced that Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Citi 2026 Virtual Oncology Leadership Summit on Thursday, February 19, 2026, at 10:00 a.m. ET.

CAMBRIDGE, Mass., Feb. 05, 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 announced that Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Thursday, February 12, 2026, at 11:00 a.m. ET.

Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data

CLN-049 monotherapy demonstrates promising efficacy, including multiple complete responses and encouraging response durability, in a heavily pretreated all-comer population of patients with R/R AML

Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients

CAMBRIDGE, Mass., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company accelerating potential high-impact therapies in autoimmune diseases and cancer, today announced its management team will participate in two upcoming investor conferences and will host a company event at the 2025 American Society of Hematology (“ASH”) Annual Meeting in Orlando, FL.

Promising Phase 1 clinical data for CLN-049, a FLT3xCD3 bispecific T cell engager, demonstrating ~30% CRc rate in heavily pretreated, all-comer population of patients with relapsed/refractory AML to be presented in oral presentation at ASH 2025

CLN-049 demonstrated anti-leukemic activity, including multiple complete responses, in a heavily pretreated population of patients with r/r AML, regardless of FLT3 mutational status

CLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases

CAMBRIDGE, Mass., Sept. 12, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Stifel 2025 Virtual Immunology and Inflammation Forum on Tuesday, September 16, 2025, at 9:30 a.m. ET.

CAMBRIDGE, Mass., Aug. 21, 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:

CLN-978 program now actively enrolling across Phase 1 studies in systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) and Sjögren’s disease

Advances Cullinan’s leadership in T cell engager (TCE) development for autoimmune diseases with both a CD19 TCE and BCMA TCE in its pipeline

CAMBRIDGE, Mass., May 29, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced its management team will host a company event at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL and will participate in the Jefferies 2025 Global Healthcare Conference, being held June 3-5, 2025 in New York, NY.

CAMBRIDGE, Mass. and TOKYO, Japan and PRINCETON, N.J., May 22, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), Taiho Pharmaceutical Co., Ltd., and Taiho Oncology, Inc. today announced new positive results from the pivotal Phase 2b cohorts of the REZILIENT1 trial, a Phase 1/2 clinical trial of zipalertinib monotherapy in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who have received prior therapy. These data will be presented on Sunday, June 1 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting as an oral presentation during the “Lung Cancer – Non-Small Cell Metastatic” session from 9:00 AM-9:12 AM CDT (Abstract #8503).

Company received approval from European Medicines Agency (EMA) for CLN-978; Phase 1 study in active, difficult-to-treat rheumatoid arthritis to initiate in Q2 2025

CLN-978 is the first and only development-stage CD19 T cell engager to receive U.S. FDA IND clearance in autoimmune diseases

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