Cullinan Oncology Inc Stock Price, News & Analysis

Cullinan Therapeutics (Nasdaq: CGEM) announced that the U.S. FDA granted Fast Track designation to CLN-049, a FLT3xCD3 T cell engager, for treatment of relapsed/refractory acute myeloid leukemia (R/R AML) on December 1, 2025. The company said Phase 1 data in heavily pre-treated patients showed promising efficacy and favorable safety, including complete responses. CLN-049 Phase 1 results will be presented in an oral presentation at the 67th ASH Annual Meeting on December 8, 2025. Cullinan stated the Fast Track designation is intended to accelerate development and facilitate collaboration with the FDA to advance CLN-049 for patients with limited treatment options.

Cullinan Therapeutics (Nasdaq: CGEM) and partners Taiho Oncology and Taiho Pharmaceutical announced a rolling submission of a New Drug Application to the U.S. FDA for zipalertinib to seek accelerated approval for treatment of locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion (ex20ins) mutations in patients previously treated with platinum chemotherapy.

The companies said zipalertinib previously received Breakthrough Therapy Designation in 2021. The NDA is based on primary efficacy data from the Phase 1/2 REZILIENT1 trial, with positive results presented at ASCO 2025 and published in the Journal of Clinical Oncology. The firms anticipate completing the NDA submission in Q1 2026 and will request priority review.

Cullinan Therapeutics (Nasdaq: CGEM) announced management participation in two investor conferences and an analyst/investor event at the 2025 ASH Annual Meeting.

CEO Nadim Ahmed and CMO Jeffrey Jones will appear in fireside chats at the Stifel Healthcare Conference in New York on Nov 11, 2025 at 3:20 p.m. ET and at the Guggenheim Healthcare Innovation Conference in Boston on Nov 12, 2025 at 8:00 a.m. ET. The company will host an in-person analyst and institutional investor event on Dec 8, 2025 at 8:00 p.m. ET in Orlando following the oral presentation of Phase 1 CLN-049 results in AML/MDS (Presentation ID 768).

Investors may register by emailing nsmith@cullinantx.com. Webcasts will be available on the company investor relations Events and Presentations page.

Cullinan Therapeutics (Nasdaq: CGEM) reported third-quarter 2025 results and a corporate update focused on T cell engager programs in immunology and oncology. Key clinical highlights include ~30% CRc for CLN-049 at clinically active doses in relapsed/refractory AML and planned oral data presentation at ASH 2025 (Dec 8, 2025). CLN-978 (CD19xCD3) will share initial SLE and RA safety and B‑cell depletion data in 1H 2026 and received a U.S. composition‑of‑matter patent extending protection to at least 2042. The company discontinued CLN-619 and CLN-617 and said partner Taiho will begin a rolling NDA for zipalertinib by year‑end, with pivotal enrollment completing in 1H 2026. Cash, cash equivalents and investments totaled $475.5M as of Sept 30, 2025, supporting a runway into 2029.

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.