Cullinan Therapeutics (CGEM) Stock News

Cullinan Therapeutics (CGEM) and Taiho reported positive Phase 3 REZILIENT3 results for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion NSCLC.

In 279 previously untreated advanced patients, zipalertinib 100 mg BID plus platinum chemotherapy achieved median progression-free survival of 14.5 vs. 8.5 months for chemotherapy alone, a 6.0‑month improvement (HR=0.50; 95% CI 0.34‑0.73; P=0.00015). Objective response rate was 65.0% vs. 40.3% with longer median duration of response (14.2 vs. 9.9 months). A prespecified interim overall survival analysis (30% maturity) showed an HR for death of 0.72 (95% CI 0.42‑1.23), with follow‑up ongoing.

The safety profile was consistent with known toxicities, though grade ≥3 adverse events were more frequent with the combination (87.1% vs. 54.4%), mainly hematologic. Zipalertinib remains investigational and is not yet approved.

Cullinan Therapeutics (CGEM) will host a virtual analyst and institutional investor event on September 14, 2026, at 8:00 a.m. ET to discuss Phase 3 REZILIENT3 data for zipalertinib plus chemotherapy in first-line EGFR exon 20 insertion mutation-positive NSCLC.

The event follows presentation of the planned interim analysis results in Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer in Seoul, South Korea. The REZILIENT3 trial previously met its primary endpoint of progression-free survival at this interim analysis. The webcast will feature CEO Nadim Ahmed and Chief Medical Officer Jeffrey Jones and will be accessible live and as an archived replay via the events page of Cullinan Therapeutics’ investor relations website.

Cullinan Therapeutics (Nasdaq: CGEM) and Taiho Oncology announced that interim results from the multicenter, randomized Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy versus chemotherapy alone in first-line EGFR exon 20 insertion-positive non-small cell lung cancer have been selected for presentation in the Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer in Seoul.

The planned interim analysis met the trial’s primary endpoint of progression-free survival in previously untreated, locally advanced or metastatic non-squamous NSCLC. REZILIENT3 enrolled 285 adults globally. Zipalertinib (CLN-081/TAS6417) is an oral, next‑generation, irreversible EGFR inhibitor targeting exon 20 insertion mutations and remains investigational, not approved by any health authority. Full abstract details will be released per IASLC embargo policy.

Cullinan Therapeutics (Nasdaq: CGEM), together with Taiho Oncology and Taiho Pharmaceutical, reported that the global Phase 3 REZILIENT3 trial in first-line EGFR exon 20 insertion mutation non-small cell lung cancer met its primary endpoint of progression-free survival at a planned interim analysis. Zipalertinib plus platinum-based chemotherapy showed a statistically significant and clinically meaningful improvement in progression-free survival versus chemotherapy alone, with manageable safety, leading the Independent Data Monitoring Committee to recommend unblinding. The open-label trial enrolled 285 previously untreated adults with locally advanced or metastatic non-squamous NSCLC. The companies plan to present full data at a future medical conference and, following discussions with the FDA, pursue U.S. regulatory approval for zipalertinib plus chemotherapy in this first-line setting. Zipalertinib remains an investigational, oral, next-generation irreversible EGFR inhibitor and is not approved by any health authority.

Cullinan Therapeutics (Nasdaq: CGEM) reported second quarter 2026 results and detailed clinical and regulatory milestones across its immunology and oncology T cell engager pipeline. CLN-978 in SLE and RA will deliver additional multi-dose data in Q3–Q4 2026, with Phase 2 expansions planned for early 2027, and initial Sjögren’s disease data expected in Q4 2026. Velinotamig multi-dose data in SLE are also expected in Q4 2026, ahead of a planned global Phase 1/2 basket study in autoimmune cytopenias in early 2027.

In oncology, a potentially registrational Phase 2 CLN-049 study in relapsed/refractory AML is set to begin in Q3 2026, with a combination Phase 1/2 trial planned in Q4 2026. The FDA has accepted the NDA for zipalertinib in EGFR ex20ins NSCLC, with a PDUFA date of February 27, 2027. According to Cullinan, cash and investments totaled $356 million as of June 30, 2026, providing runway into 2029, while Q2 2026 R&D expenses were $44.4 million, G&A $12.8 million, and net loss $53.7 million.

Cullinan Therapeutics (Nasdaq: CGEM) reported positive feedback from the U.S. FDA following an End-of-Phase 1 meeting for CLN-049, a FLT3xCD3 T cell engager in acute myeloid leukemia (AML). Based on this interaction, Cullinan plans to start a potentially registrational Phase 2 study in relapsed/refractory AML in Q3 2026, using a design that includes a short dose-optimization phase and seamless transition to a single-arm cohort at the recommended Phase 2 dose.

CLN-049 has shown promising clinical activity and a favorable safety profile in relapsed/refractory AML and holds Orphan Drug and Fast Track designations for this indication. Cullinan expects an update from the dose-escalation portion of the ongoing Phase 1 trial in Q4 2026 and plans a Phase 1/2 combination study with venetoclax and azacitidine in previously untreated AML. CLN-049 targets FLT3-expressing leukemia cells, including both mutated and non-mutated FLT3, and is also being evaluated in AML with measurable residual disease and in myelodysplastic syndrome.

Cullinan Therapeutics (Nasdaq: CGEM) reported new clinical data for its T cell engagers CLN-978 (CD19xCD3) and velinotamig (BCMAxCD3) in autoimmune diseases.

Results included clinical remissions and deep B cell depletion in refractory SLE and RA, complete renal responses in lupus nephritis, favorable safety, and defined timelines for further data and Phase 2a expansions through 2027.

Cullinan Therapeutics (Nasdaq: CGEM) reported initial Phase 1 data for CLN-978, a CD19xCD3 T cell engager, in refractory SLE and difficult-to-treat RA at EULAR 2026.

Among 29 patients, single-dose treatment showed clinical activity, deep B cell depletion in blood and tissue, and a generally manageable safety profile up to 30 µg. Further multi-dose data are expected at Immunology Day on June 10.

Cullinan Therapeutics (Nasdaq: CGEM) will host an in-person Immunology Day for analysts and institutional investors on June 10, 2026, at 8:30 a.m. ET in New York City.

The event will showcase new and updated clinical data for CLN-978 in systemic lupus erythematosus and rheumatoid arthritis, and velinotamig in treatment‑refractory autoimmune diseases driven by long‑lived plasma cells, including first multi‑dose cohort results and global development plans.