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Zipalertinib shows 30% intracranial response rate in lung cancer trial

Mon, 19 Oct 2026 07:03:44 -0400

Taiho Oncology and Cullinan Therapeutics (Nasdaq: CGEM) announced results from Cohort C of the Phase 2 REZILIENT2 trial evaluating zipalertinib monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations or other uncommon EGFR mutations and active central nervous system (CNS) metastases.

Among 43 evaluable patients, zipalertinib achieved an intracranial objective response rate of 30.2%, an intracranial disease control rate of 72.1%, and a median intracranial duration of response of 9.7 months. Among 24 patients without prior EGFR tyrosine kinase inhibitor exposure, the intracranial objective response rate was 37.5%.

The trial enrolled 59

Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases

Mon, 19 Oct 2026 07:00:00 -0400

Intracranial Objective Response Rate of 30.2% was observed in 43 evaluable patients

Results to be shared in poster presentation at ESMO Congress 2026

PRINCETON, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Taiho Oncology, Inc. and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced results from Cohort C of the Phase 2 REZILIENT2 trial evaluating zipalertinib monotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations or other uncommon EGFR mutations and active central nervous system (CNS) metastases. The data will be presented

Zipalertinib Demonstrates Clinically Meaningful Intracranial Antitumor Activity in Patients with NSCLC with EGFR Exon 20 Insertion or Uncommon EGFR Mutations and Active CNS Metastases

Mon, 19 Oct 2026 07:00:00 -0400

Intracranial Objective Response Rate of 30.2% was observed in 43 evaluable patients

Results to be shared in poster presentation at ESMO Congress 2026

Cullinan Therapeutics doses first patient in phase 2 AML study

Thu, 08 Oct 2026 07:00:17 -0400

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) announced that the first patient has been dosed in a pivotal Phase 2 study of CLN-049, an investigational FLT3xCD3 T cell engager, in patients with relapsed or refractory acute myeloid leukemia (AML).

The study is designed to evaluate CLN-049 in AML patients who have received up to two prior lines of therapy. Following an End-of-Phase 1 meeting with the U.S. Food and Drug Administration, the potentially registrational study includes a dose-optimization phase evaluating two target dose levels, followed by advancement to a single-arm expansion cohort at the recommended Phase 2 dose. The study also includes an

Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia

Thu, 08 Oct 2026 07:00:00 -0400

CAMBRIDGE, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that the first patient has been dosed in its pivotal Phase 2 study of CLN-049, a novel, investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia (AML).

“Patients with relapsed or refractory AML continue to face poor outcomes and limited treatment options, underscoring the urgent need for new treatment approaches that can benefit a broad range of patients,”

Cullinan Therapeutics Announces First Patient Dosed in Planned Registrational Phase 2 Study of CLN-049 in Relapsed/Refractory Acute Myeloid Leukemia

Thu, 08 Oct 2026 07:00:00 -0400

H.C. Wainwright Reiterates Buy Rating on Cullinan Oncology Inc. (CGEM)

Fri, 02 Oct 2026 06:57:39 -0400

H.C. Wainwright analyst Robert Burns reiterated a Buy rating and $35.00 price target on Cullinan Oncology Inc. (NASDAQ: CGEM).

The analyst commented: "Last night, Cullinan and its partner, Taiho Oncology, announced the initiation of a rolling NDA submission under the FDA’s RTOR pathway for zipalertinib + platinum-based chemo in 1L EGFR Ex20Ins+ NSCLC, with completion expected by YE26. The filing is supported by results from the Phase 3 REZILIENT3 trial, in which zipalertinib + chemo (n=140; 40% Asian; 31.4% baseline brain mets) demonstrated a 65% ORR (6.4% CR), 14.2-month mDOR, and 14.5-month mPFS vs a 40.3% ORR (2.2% CR), 9.9-month mDOR,

Form 8-K Cullinan Therapeutics, For: Oct 01

Fri, 02 Oct 2026 06:03:00 -0400

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Cullinan files NDA for zipalertinib combo in first-line lung cancer

Thu, 01 Oct 2026 19:30:16 -0400

Cullinan Therapeutics, Inc. (NASDAQ: CGEM) announced the initiation of a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for zipalertinib in combination with platinum-based chemotherapy for the treatment of previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.

The submission is being made under the FDA's Real-Time Oncology Review (RTOR) program, which allows sponsors to submit clinical data ahead of a complete application to facilitate earlier review. Cullinan expects to complete the full NDA submission by year-end 2026.

The NDA is supported by data from the Phase 3 REZILIENT3

New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

Thu, 01 Oct 2026 19:30:00 -0400

In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival observed to date in first-line EGFR exon20ins NSCLC

After agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission expected by year-end 2026

CAMBRIDGE, Mass., Oct. 01, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced the initiation of a New Drug Application (NDA) submission to the U.S. Food and Drug

New Drug Application Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA Real-Time Oncology Review Program

Thu, 01 Oct 2026 19:30:00 -0400

In the Phase 3 REZILIENT3 study, zipalertinib combination therapy demonstrated longest median progression-free survival observed to date in first-line EGFR exon20ins NSCLC

After agreement with the U.S. FDA, Real-Time Oncology Review program submission process initiated; completion of NDA submission expected by year-end 2026

Cullinan Therapeutics plans Q4 2026 data readouts for three pipeline drugs

Thu, 24 Sep 2026 07:02:09 -0400

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) announced plans to release clinical data across three of its T cell engager programs during the fourth quarter of 2026, according to a press release from the Cambridge, Mass.-based biopharmaceutical company.

The company said it will present multi-dose regimen data from the ongoing Phase 1 dose escalation study of velinotamig, a BCMAxCD3 T cell engager, in systemic lupus erythematosus (SLE) at the ACR Convergence 2026 conference on November 8, 2026.

In December, Cullinan plans to share multi-dose and single target dose regimen data for CLN-978, a CD19xCD3 T cell engager, across three indications: treatment-refractory moderate to severe

Cullinan Therapeutics plans Q4 2026 data readouts for three pipeline drugs

Thu, 24 Sep 2026 07:02:09 -0400

In December, Cullinan plans to share multi-dose and single target dose regimen data for CLN-978, a CD19xCD3 T cell engager, across three indications: treatment-refractory moderate to severe

Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio

Thu, 24 Sep 2026 07:00:00 -0400

Velinotamig (BCMA TCE) multi-dose regimen data in SLE at ACR Convergence 2026 in November

CLN-978 (CD19 TCE) multi-dose regimen data in SLE, RA and Sjögren’s disease in December

CLN-049 (FLT3 TCE) updated data from the Phase 1 dose escalation study in December

CAMBRIDGE, Mass., Sept. 24, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today outlined fourth quarter 2026 milestones across its immunology and oncology pipeline.

“We look

Cullinan Therapeutics Highlights Fourth Quarter 2026 Milestones Across Immunology and Oncology T Cell Engager Portfolio

Thu, 24 Sep 2026 07:00:00 -0400

Velinotamig (BCMA TCE) multi-dose regimen data in SLE at ACR Convergence 2026 in November

CLN-978 (CD19 TCE) multi-dose regimen data in SLE, RA and Sjögren’s disease in December

CLN-049 (FLT3 TCE) updated data from the Phase 1 dose escalation study in December

“We look

Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum

Mon, 21 Sep 2026 12:00:00 -0400

CAMBRIDGE, Mass., Sept. 21, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, M.D., M.B.A., Chief Medical Officer, will participate in a fireside chat at the Stifel 2026 Virtual Immunology and Inflammation Forum on Thursday, September 24, 2026, at 1:30 p.m. ET.

A webcast of the fireside chat will be available under the Events and Presentations section of the Company’s investor relations website at

Cullinan Therapeutics to Participate in the Stifel 2026 Virtual Immunology and Inflammation Forum

Mon, 21 Sep 2026 12:00:00 -0400

A webcast of the fireside chat will be available under the Events and Presentations section of the Company’s investor relations website at

Cullinan Oncology Inc. (CGEM) PT Raised to $40 at BTIG

Mon, 14 Sep 2026 12:45:18 -0400

BTIG analyst Julian Harrison raised the price target on Cullinan Oncology Inc. (NASDAQ: CGEM) to $40.00 (from $39.00) while maintaining a Buy rating.

The analyst comments "CGEM presented positive Phase 3 REZILIENT3 data during a Presidential Symposium at the IASLC 2026 WCLC, demonstrating a statistically significant improvement in PFS for zipalertinib + chemo vs chemo alone in 1L EGFR exon20ins NSCLC. The combination reduced the risk of disease progression by 50% (HR=0.50; p=0.00015) and improved mPFS to 14.5 months vs 8.5 months for chemo alone, while also improving objective response rate (65.0% vs. 40.3%) and extending median duration of response (14.2

Cullinan Oncology Inc. (CGEM) PT Raised to $40 at BTIG

Mon, 14 Sep 2026 12:45:18 -0400

BTIG analyst Julian Harrison raised the price target on Cullinan Oncology Inc. (NASDAQ: CGEM) to $40.00 (from $39.00) while maintaining a Buy rating.

Stifel Reiterates Buy Rating on Cullinan Oncology Inc. (CGEM)

Mon, 14 Sep 2026 11:05:59 -0400

Stifel analyst Alex Thompson reiterated a Buy rating and $28.00 price target on Cullinan Oncology Inc. (NASDAQ: CGEM).

The analyst comments "We reiterate our Buy Rating on CGEM following presentation of the REZILIENT3 Ph3 data of Zipalertinib in 1L EGFR ex20mut NSCLC. On the primary endpoint PFS, Zipalertinib+chemo demonstrated a 14.5- vs. 8.5-month benefit (p=0.00015) at the interim with early trends on overall survival. Bottom line, these data look competitive/better on a cross-trial basis vs. amivantamab (efficacy and safety) and could support meaningful share accrual over time. CGEM has a 50/50 profit share with Taiho and is also eligible for $130MM

TD Cowen Reiterates Buy Rating on Cullinan Oncology Inc. (CGEM)

Mon, 14 Sep 2026 11:05:30 -0400

TD Cowen analyst Phil Nadeau reiterated a Buy rating on Cullinan Oncology Inc. (NASDAQ: CGEM).

The analyst comments "We currently model peak sales of $225MM based on 25% penetrance of the 4.5K U.S. population and 12 months average duration, based mainly on use in 2L. The REZILIENT3 results suggest there is much potential upside to both penetration and average duration relative to our initial estimates, implying peak sales potential of $1B. Zipa's NDA is currently under review for approval in the 2L setting with a Feb. 27 PDUFA. While regulatory filing is ultimately controlled by Taiho, management notes that the REZILIENT3

Cullinan Therapeutics to host investor event on Phase 3 lung cancer trial

Mon, 14 Sep 2026 07:00:27 -0400

Cullinan Therapeutics, Inc. (Nasdaq: CGEM) announced it will host a virtual event for analysts and institutional investors to discuss interim analysis results from its Phase 3 REZILIENT3 trial, which evaluated zipalertinib in combination with chemotherapy.

The data were presented at the International Association for the Study of Lung Cancer's 2026 World Conference on Lung Cancer, in a Presidential Symposium session.

The virtual event is scheduled for 8:00 a.m. ET on Sept. 14, 2026. Participants from Cullinan Therapeutics include Nadim Ahmed, Chief Executive Officer, and Jeffrey Jones, MD, MBA, Chief Medical Officer.

The Cambridge, Mass.-based company said a live webcast and subsequent replay will

Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer

Mon, 14 Sep 2026 07:00:00 -0400

Company to host a virtual event today at 8:00 a.m. ET

CAMBRIDGE, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, disease-modifying T cell engagers in autoimmune diseases and cancer, today announced that it will host a virtual event for analysts and institutional investors today at 8:00 a.m. ET to discuss the results from the planned interim analysis of the Phase 3 REZILIENT3 trial of zipalertinib plus chemotherapy presented in Presidential Symposium 2 at the International Association for the Study of Lung Cancer’s (IASLC)

Cullinan Therapeutics to Host Virtual Analyst and Investor Event Today to Feature Zipalertinib Plus Chemotherapy Phase 3 REZILIENT3 Data Presented at the IASLC 2026 World Conference on Lung Cancer

Mon, 14 Sep 2026 07:00:00 -0400

Company to host a virtual event today at 8:00 a.m. ET

Zipalertinib combo shows 6-month PFS gain in lung cancer trial

Sun, 13 Sep 2026 19:15:22 -0400

Taiho Oncology, Taiho Pharmaceutical, and Cullinan Therapeutics (Nasdaq: CGEM) announced results from the Phase 3 REZILIENT3 trial showing that zipalertinib combined with platinum-based chemotherapy produced a statistically significant improvement in progression-free survival (PFS) for patients with EGFR exon 20 insertion mutation-positive non-small cell lung cancer (NSCLC).

The data, presented at the International Association for the Study of Lung Cancer's 2026 World Conference on Lung Cancer in Seoul, South Korea, showed a median PFS of 14.5 months for the combination arm versus 8.5 months for chemotherapy alone, a difference of 6.0 months (HR=0.50; 95% CI, 0.34-0.73; P=0.00015).

The trial enrolled 279 patients with