Cullinan Therapeutics: Heading Toward Paydirt

Cullinan Therapeutics remains a compelling buy as zipalertinib approaches a key FDA decision for EGFR exon 20 insertion NSCLC. Zipalertinib demonstrates promising efficacy, including CNS activity and responses post-amivantamab, with pivotal phase 3 REZILIENT3 data expected later this year. CGEM's diversified pipeline in oncology and immunology, strong cash reserves, and operational runway into 2029 support continued optimism.

Seeking Alpha • Jun 11, 2026

Cullinan Therapeutics, Inc. (CGEM) Discusses Promising Clinical Data for CLN-978 and Velinotamig in Autoimmune Diseases Transcript

Cullinan Therapeutics, Inc. (CGEM) Discusses Promising Clinical Data for CLN-978 and Velinotamig in Autoimmune Diseases Transcript

Seeking Alpha • Jun 10, 2026

Cullinan Therapeutics Shares New Clinical Data Across Its Portfolio of T Cell Engager Programs Targeting CD19 and BCMA in Autoimmune Diseases

CLN-978 (CD19 TCE) EULAR data demonstrated potential for immune reset, including remissions, in both systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA)

GlobeNewsWire • Jun 10, 2026

Cullinan Therapeutics to Host Immunology Day to Showcase Promising Initial Clinical Data in Autoimmune Diseases for CLN-978, a CD19 T Cell Engager, and Velinotamig, a BCMA T Cell Engager

New and updated clinical data to be presented from over 30 patients across systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) studies  Initial data from the first multi-dose cohort of RA study to be presented Initial data from the first multi-dose cohort of velinotamig study also to be shared Leading key opinion leaders Dr. Ricardo Grieshaber-Bouyer and Dr. John Tesser to share clinical perspectives The Company will host the in-person event for analysts and institutional investors on Wednesday, June 10, starting at 8:30 a.m. ET in New York City CAMBRIDGE, Mass.

GlobeNewsWire • May 26, 2026

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

Orphan Drug Designation underscores the potential of CLN-049, a novel FLT3xCD3 T cell engager, to address significant unmet need in AML

GlobeNewsWire • May 19, 2026

Cullinan Therapeutics to Present Initial Clinical Data for CLN-978 in Treatment-Refractory Rheumatoid Arthritis and Systemic Lupus Erythematosus at EULAR 2026 Congress

CAMBRIDGE, Mass., May 18, 2026 (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 initial clinical data from two ongoing Phase 1 studies evaluating CLN-978, a subcutaneously administered CD19xCD3 T cell engager, will be presented at the European Alliance of Associations for Rheumatology (EULAR) European Congress of Rheumatology being held June 3-6, 2026 in London, United Kingdom.

GlobeNewsWire • May 18, 2026

Cullinan Therapeutics Provides Corporate Update and Reports First Quarter 2026 Financial Results

Initial clinical data in SLE and RA for CLN-978, a CD19 T cell engager, to be presented at the EULAR 2026 Congress in June; multi-dose regimen data in RA expected in Q3 2026  Zipalertinib NDA for relapsed EGFR ex20ins NSCLC accepted by U.S. FDA; PDUFA target action date of February 27, 2027 Cash and investments of $393.3 million as of March 31, 2026; runway into 2029 CAMBRIDGE, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, 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 first quarter ended March 31, 2026.

GlobeNewsWire • May 7, 2026

Cullinan Therapeutics: Cash-Rich With A Major 2027 FDA Catalyst

Cullinan Therapeutics's Zipalertinib NDA has been accepted, making its February 27, 2027, PDUFA date their clearest near-term catalyst. Zipalertinib targets EGFR exon 20 insertion NSCLC, a niche but still meaningful demographic that could expand over time with more trials for new indications. CGEM's CLN-978, Velinotamig, and CLN-049 add other interesting assets in their pipeline across autoimmune disease and AML.

Seeking Alpha • Apr 30, 2026

U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

PRINCETON, N.J. & TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for zipalertinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations whose disease has progressed.

Business Wire • Apr 28, 2026

Cullinan Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full Year 2025 Financial Results

Initial clinical data for CLN-978 in SLE and RA confirmed for Q2 2026; repeat dosing data in RA confirmed for Q3 2026 Zipalertinib rolling NDA submission completed; enrollment of REZILIENT3 frontline study completed with top-line results available by year-end 2026 Cash and investments of $439.0 million as of December 31, 2025; runway into 2029 CAMBRIDGE, Mass., March 10, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, 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 fourth quarter and full year ended December 31, 2025.

GlobeNewsWire • Mar 10, 2026