Cullinan Oncology Inc Stock Price, News & Analysis

Cullinan Therapeutics (Nasdaq: CGEM) reported Phase 1 CLN-049 data in relapsed/refractory AML and MDS showing anti-leukemic activity and a manageable safety profile as of a June 2025 cutoff.

Key data: across target doses ≥6 μg/kg (n=23 AML) CRc 30% and ORR 57%; at 12 μg/kg (n=13) CRc 31% and ORR 69%. Responses occurred regardless of FLT3 mutational status, including 4 responses in 5 TP53‑mutated AML patients. CRS occurred in 40% (all Grade 1–2); Grade ≥3 febrile neutropenia and WBC decrease were 17.5% each. Dose escalation is ongoing and updated results will be presented at ASH 2025 on December 8.

Cullinan Therapeutics (Nasdaq: CGEM) will present new preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at ACR Convergence 2025 (poster session Oct 28, Poster 2293; Booth #1074).

Preclinical results showed rapid, dose-dependent B cell depletion in human PBMCs from RA, Sjögren's, and SLE patients and in nonhuman primates after subcutaneous dosing, with sustained depletion in blood, bone marrow, and lymph nodes. In an SLE mouse model, CLN-978 reduced circulating B cells, anti-dsDNA IgG, and kidney IgG deposition. The company is advancing OUTRACE clinical programs in RA (NCT06994143), SjD (NCT07041099), and SLE (NCT06613360).

Taiho Oncology and Cullinan Therapeutics (NASDAQ:CGEM) will present preliminary Phase 2b REZILIENT2 CNS cohort data for oral EGFR inhibitor zipalertinib at ESMO Congress on October 19, 2025 (mini oral, NSCLC metastatic session).

As of the Feb 2025 cutoff, 32 patients received zipalertinib 100 mg twice daily (median 2 prior therapies). In 16 RANO-BM evaluable patients with measurable CNS disease, intracranial ORR was 31.3% (including 1 CR), iDCR 68.8%, and median intracranial DOR 8.1 months. Systemic ORR measured in 29 patients was 27.6% with median DOR 7.6 months.

Safety at 100 mg BID showed treatment-related grade ≥3 AEs in 25% (8 patients); notable events included anemia (n=3), interstitial lung disease (n=2) and one death attributed to interstitial lung disease.

Cullinan Therapeutics (Nasdaq: CGEM), a biopharmaceutical company specializing in modality-agnostic targeted therapies, has announced its participation in the upcoming Stifel 2025 Virtual Immunology and Inflammation Forum.

The company's Chief Medical Officer, Jeffrey Jones, M.D., M.B.A., will engage in a fireside chat on Tuesday, September 16, 2025, at 9:30 a.m. ET. Investors can access the webcast through Cullinan's investor relations website under the Events and Presentations section.

Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology presented new data from two clinical trials of zipalertinib at the IASLC 2025 World Conference on Lung Cancer. The REZILIENT1 trial showed promising results in NSCLC patients with EGFR ex20ins mutations who previously received amivantamab, achieving a 27.4% confirmed objective response rate with 8.5 months median duration of response.

In the REZILIENT2 trial, zipalertinib demonstrated efficacy in patients with uncommon non-ex20ins EGFR mutations, with a 30% confirmed objective response rate and 7.75 months median duration of response. Notably, treatment-naïve patients showed a significantly higher response rate of 62.5% compared to 21.9% in previously treated patients.

Both trials demonstrated a manageable safety profile for zipalertinib, with most adverse events being grade 1 or 2.

Cullinan Therapeutics (Nasdaq: CGEM), a biopharmaceutical company specializing in modality-agnostic targeted therapies, has announced its participation in two upcoming investor conferences. CEO Nadim Ahmed and CMO Jeffrey Jones will present at the Cantor Global Healthcare Conference on September 4, 2025, at 2:10 p.m. ET, and at the Morgan Stanley 23rd Annual Global Healthcare Conference on September 10, 2025, at 8:30 a.m. ET.

Both presentations will be available as webcasts through Cullinan's investor relations website.

Cullinan Therapeutics (NASDAQ:CGEM) provided a comprehensive Q2 2025 corporate update, highlighting significant progress across its immunology and oncology portfolios. The company reported $510.9 million in cash and investments, providing runway into 2028. Key developments include active enrollment in Phase 1 studies for CLN-978 across multiple autoimmune conditions, the in-licensing of velinotamig from Genrix Bio for $20 million upfront, and advancement of zipalertinib's pivotal trials.

Financial results show R&D expenses of $61.0 million (up from $36.3M in Q2 2024) and a net loss of $70.1 million (increased from $42.0M). The company strengthened its board with the appointments of Drs. Mittie Doyle and Andrew Allen, while announcing upcoming data presentations across multiple programs at major medical conferences.

Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology announced the acceptance of two abstracts for presentation at the IASLC 2025 World Conference on Lung Cancer in Barcelona, featuring new data for zipalertinib in non-small cell lung cancer (NSCLC).

The presentations will include updated efficacy data from the Phase 2b REZILIENT1 trial studying zipalertinib in patients with EGFR exon 20 insertion mutations who previously received amivantamab treatment. Additionally, preliminary findings from the Phase 2 REZILIENT2 trial will be presented, focusing on patients with uncommon non-ex20ins EGFR mutations.

Both abstracts will be presented on September 9, 2025, during the mini oral session "Common and Uncommon EGFR Mutations, New Treatments in the Horizon." Full abstract details will be available on August 13, 2025.

Cullinan Therapeutics (NASDAQ: CGEM) has secured exclusive global rights (excluding Greater China) to velinotamig, a BCMAxCD3 bispecific T cell engager, from Genrix Bio. The deal includes a $20 million upfront payment, potential milestone payments up to $692 million, and tiered royalties ranging from mid-single digits to mid-teens. Velinotamig has shown promising Phase 2 results in multiple myeloma patients and will be developed for autoimmune diseases. Genrix Bio will initiate a Phase 1 study in China for autoimmune diseases by year-end, with data to be used by Cullinan for global development. The acquisition complements Cullinan's existing CLN-978 program and maintains their cash runway into 2028.