Welcome to our dedicated page for Cullinan Oncology news (Ticker: CGEM), a resource for investors and traders seeking the latest updates and insights on Cullinan Oncology stock.
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a clinical-stage biopharmaceutical company developing potential first- or best-in-class therapies for autoimmune diseases and cancer. The CGEM news feed highlights the company’s ongoing clinical progress, regulatory interactions, and scientific presentations across its portfolio of T cell engagers and targeted therapies.
News updates frequently cover clinical trial data for key assets such as CLN-049, an FLT3xCD3 bispecific T cell engager in relapsed/refractory acute myeloid leukemia and myelodysplastic syndrome, and CLN-978, a CD19xCD3 bispecific T cell engager being studied in systemic lupus erythematosus, rheumatoid arthritis, and Sjögren’s disease. Releases detail efficacy signals, safety profiles, B cell depletion data, and outcomes in high-risk patient subsets, often presented at major medical meetings like ASH, ASCO, ESMO, ACR, and WCLC.
The CGEM news section also features updates on zipalertinib (CLN-081/TAS6417), an EGFR tyrosine kinase inhibitor for non-small cell lung cancer with EGFR exon 20 insertion and other uncommon mutations, developed in collaboration with Taiho Oncology and Taiho Pharmaceutical. These stories include information on Breakthrough Therapy Designation, rolling New Drug Application submissions, and data from REZILIENT trials, including cohorts with active brain metastases.
Investors and followers of Cullinan Therapeutics can use this page to review corporate updates, SEC-related announcements furnished via press release, and portfolio decisions such as program prioritizations or discontinuations. For anyone tracking CGEM, the news feed provides a consolidated view of the company’s disclosed milestones, scientific progress, and regulatory steps across its autoimmune and oncology programs.
Cullinan Therapeutics is expanding its clinical development program for CLN-978, a novel bispecific CD19 T cell engager, to include Sjögren's disease patients in the United States. This marks CLN-978 as the first CD19 T cell engager to receive FDA IND clearance for autoimmune diseases.
The study will focus on patients with active, moderate to severe Sjögren's disease who meet specific clinical criteria. The trial's primary goal is to assess safety and tolerability, with secondary objectives including pharmacokinetics and disease activity effects.
CLN-978 is already being studied for systemic lupus erythematosus in the U.S., Australia, and Europe, and for rheumatoid arthritis at European sites. The treatment offers a differentiated approach through deep B cell depletion and convenient subcutaneous administration. With approximately 4 million Americans affected by Sjögren's disease and no currently approved comprehensive treatments, this development addresses a significant unmet medical need.
Cullinan Therapeutics (NASDAQ: CGEM) announced that results from their REZILIENT1 study of zipalertinib in non-small cell lung cancer (NSCLC) patients will be presented at the 2025 ASCO Annual Meeting. The Phase 2b trial, which met its primary endpoint of overall response rate, evaluated zipalertinib monotherapy in patients with advanced or metastatic EGFR exon 20 insertion mutations who progressed after prior platinum-based chemotherapy.
The study demonstrated clinically meaningful efficacy and a manageable safety profile in patients previously treated with platinum-based chemotherapy, including those treated with amivantamab. Dr. Helena A. Yu from Memorial Sloan Kettering Cancer Center will present the findings on June 1, 2025. The company will also host an investor event featuring Dr. Danny Nguyen from City of Hope National Medical Center to discuss the data.
Cullinan Therapeutics (Nasdaq: CGEM) has received European Medicines Agency (EMA) approval for a Phase 1 clinical trial of CLN-978, a bispecific CD19 T cell engager, in rheumatoid arthritis patients. The trial will commence in Q2 2025 at research institutions in Germany and Rome.
The open-label study will evaluate CLN-978's safety, pharmacokinetics, pharmacodynamics, and effects on disease activity in patients with active, difficult-to-treat rheumatoid arthritis. The drug is administered subcutaneously and is currently being studied for systemic lupus erythematosus across the U.S., Europe, and Australia.
CLN-978 is notable as the only CD19-targeting T cell engager with a global regulatory development plan including FDA-cleared IND. The therapy aims to provide off-the-shelf access and convenient subcutaneous dosing for autoimmune disease patients.
Cullinan Therapeutics (NASDAQ: CGEM) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical pipeline. The company's lead candidate CLN-978, the first CD19 T cell engager in autoimmune disease trials in the U.S., expects initial clinical data for Systemic Lupus Erythematosus in Q4 2025. Zipalertinib's pivotal Phase 2b study met its primary endpoint, with NDA submission planned for H2 2025.
Financial highlights include cash position of $606.9 million providing runway into 2028. Q4 2024 showed R&D expenses of $40.5 million and G&A expenses of $14.6 million. The company reported a net loss of $47.6 million for Q4 2024 and $167.4 million for the full year.
Cullinan Therapeutics (Nasdaq: CGEM) has announced its participation in two major upcoming investor conferences in March 2025. The company's leadership team, including Chief Executive Officer Nadim Ahmed and Chief Medical Officer Jeffrey Jones, will engage in fireside chats at both events.
The first appearance will be at the TD Cowen 45th Annual Health Care Conference in Boston on March 4, 2025, at 11:10 a.m. ET. The second presentation is scheduled for the Leerink Partners Global Healthcare Conference in Miami Beach on March 11, 2025, at 11:20 a.m. ET.
Investors and interested parties can access webcasts of both fireside chats through the Events and Presentations section of Cullinan's investor relations website.
Cullinan Therapeutics (Nasdaq: CGEM), a biopharmaceutical company specializing in modality-agnostic targeted therapies, has announced its participation in the upcoming Guggenheim Securities SMID Cap Biotech Conference in New York.
The company's CEO Nadim Ahmed and Chief Medical Officer Jeffrey Jones, M.D., M.B.A., will engage in a fireside chat scheduled for Wednesday, February 5, 2025, at 9:30 a.m. ET. Investors and interested parties can access the webcast through the Events and Presentations section of Cullinan's investor relations website.
Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics announced successful results from their REZILIENT1 trial, a Phase 1/2 clinical study of zipalertinib (CLN-081/TAS6417). The trial met its primary endpoint of overall response rate in patients with non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations who received prior therapy.
The safety profile aligned with previous data presentations. The companies plan to present complete results at an upcoming international medical conference and intend to submit for FDA regulatory approval in the second half of 2025, pending discussions with the agency.
Cullinan Therapeutics (NASDAQ: CGEM) will present new preclinical data for CLN-978, its CD19xCD3 T cell engager, at ACR Convergence 2024. The in vitro data shows CLN-978 induced similar T cell activation and B cell depletion in samples from SLE and RA patients compared to healthy volunteers. The company received FDA clearance and Australian approval for a global Phase 1b trial in moderate to severe systemic lupus erythematosus patients. The trial will evaluate doses between 10-45 mcg, with initial clinical data expected in Q4 2025. The study aims to assess safety, pharmacokinetics, B cell kinetics, immunogenicity, and clinical activity.