Cullinan Oncology

CGEM

Market cap $642M

Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026 Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026 Preliminary cash and investments of $439.0 million as of December 31, 2025; Runway into 2029 CAMBRIDGE, Mass., Jan. 08, 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 a corporate update and shared anticipated business highlights for 2026.

Cullinan Therapeutics, Inc. (CGEM) Discusses Initial CLN-049 Results and Development Strategy for AML Applications Transcript

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 31% CR/CRh rate observed at the highest target dose tested to date; initial dose escalation results in 45 patients demonstrate a favorable safety profile across all doses assessed CLN-049 recently granted Fast Track designation by the U.S. FDA Company to host in-person event on Monday, December 8, at 8:00 p.m. ET CAMBRIDGE, Mass.

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., Dec. 01, 2025 (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 the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CLN-049 for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML).

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

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 Company to share initial data for CLN-978, a CD19xCD3 bispecific T cell engager, in both SLE and RA in first half of 2026 Based on review of emerging clinical data, CLN-619 and CLN-617 programs discontinued Cash and investments of $475.5 million as of September 30, 2025; Runway into 2029 CAMBRIDGE, Mass., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a biopharmaceutical company accelerating potential 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 third quarter ended September 30, 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 ~30% CRc rate observed at clinically active target doses; initial dose escalation results in 40 patients indicate a manageable safety profile across all doses assessed Company to host in-person event on Monday, December 8, 2025, at 8:00 p.m. ET CAMBRIDGE, Mass.

CLN-978 led to rapid and deep B cell depletion in vitro and in vivo in multiple autoimmune diseases CAMBRIDGE, Mass., Oct. 25, 2025 (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, will present new preclinical data for CLN-978, its novel investigational CD19xCD3 bispecific T cell engager.

Cullinan Therapeutics is down some 70% since May 2024, mainly due to lack of data from its autoimmune candidate CLN-978. CLN-978, an off-the-shelf CD19xCD3 T-cell engager, targets autoimmune diseases like SLE, with initial data expected in late 2025. Zipalertinib, Cullinan's lead asset for NSCLC, faces stiff competition and limited market potential despite ongoing pivotal trials and a planned NDA in 2H25.