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

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

Seeking Alpha • Dec 9, 2025

Cullinan Therapeutics Showcases Compelling Clinical Data in AML for CLN-049, Novel FLT3xCD3 T Cell Engager, in Oral Presentation at the 67th ASH Meeting

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.

GlobeNewsWire • Dec 8, 2025

Cullinan Therapeutics Receives FDA Fast Track Designation for CLN-049, a Novel FLT3xCD3 T Cell Engager, in Relapsed/Refractory Acute Myeloid Leukemia

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).

GlobeNewsWire • Dec 1, 2025

Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics Initiate Rolling Submission of New Drug Application to U.S. Food and Drug Administration for Zipalertinib for Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

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

PRNewsWire • Nov 20, 2025

Cullinan Therapeutics to Participate in Upcoming Investor Conferences and Host Analyst and Investor Event at 2025 ASH Annual Meeting

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.

GlobeNewsWire • Nov 10, 2025

Cullinan Therapeutics Provides Corporate Update and Reports Third Quarter 2025 Financial Results

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.

GlobeNewsWire • Nov 6, 2025

Cullinan Therapeutics to Showcase New Data Demonstrating Compelling Clinical Activity for CLN-049, a Novel FLT3xCD3 T Cell Engager, in AML Patients in an Oral Presentation at the 67th ASH Annual Meeting

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.

GlobeNewsWire • Nov 3, 2025

Cullinan Therapeutics Shares Additional Preclinical B Cell Depletion Data for CLN-978, Supporting Clinical Development Across Multiple Autoimmune Diseases, at ACR Convergence 2025

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.

GlobeNewsWire • Oct 25, 2025

Cullinan Therapeutics: Worthy Of A Small Position

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.

Seeking Alpha • Oct 17, 2025

Cullinan Therapeutics Cancer Drug Shows Efficacy In Brain Metastases Among Lung Cancer Patients With Certain Mutations

Taiho Oncology Inc. and Cullinan Therapeutics Inc. (NASDAQ:CGEM) shared new data on Sunday from the central nervous system (CNS) involvement cohort of the REZILIENT2 study of zipalertinib for advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations (ex20ins) or uncommon non-ex20ins EGFR mutations.

Benzinga • Oct 13, 2025