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

One fast-rising biotech is gearing up for pivotal trials just as a major specialist fund walks away—here’s what long-term investors should take from that divergence.

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

A brutal 90% single-day crash and a shareholder’s full exit raise the stakes for MoonLake’s upcoming FDA meeting.

A brutal 90% single-day crash and a shareholder’s full exit raise the stakes for MoonLake’s upcoming FDA meeting.

One fast-rising biotech is gearing up for pivotal trials just as a major specialist fund walks away—here’s what long-term investors should take from that divergence.

Here’s what a complete fund exit reveals about sentiment toward one of biotech’s endocrine drug developers.

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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.

Cullinan Therapeutics (CGEM) beat Q3 2025 EPS estimates, announced a strategic pipeline focus, and has cash into 2029.

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

Zipalertinib shows 31% intracranial response and good tolerability in CNS-involved EGFR-mutated lung cancer, data presented at ESMO 2025.