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 Oncology Inc (CGEM) delivers innovative therapies for cancer and autoimmune diseases through a unique, cost-efficient development model. This page provides comprehensive access to official announcements, clinical trial updates, and strategic partnership news directly impacting the company's trajectory.
Investors and researchers will find timely updates on pipeline advancements, regulatory milestones, and financial disclosures. Our curated collection includes:
• Clinical development progress across multiple oncology targets
• Collaborative research announcements with academic institutions
• Financial performance updates and capital allocation strategies
• Therapeutic modality innovations in immuno-oncology
Bookmark this page for verified updates from Cullinan Oncology's leadership team and partners, ensuring you stay informed about developments in precision medicine frontier.
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.
Cullinan Therapeutics (NASDAQ: CGEM) reported Q3 2024 financial results and corporate updates. The company received regulatory clearances to initiate a global Phase 1 study of CLN-978 in systemic lupus erythematosus, with initial data expected in Q4 2025. Their oncology pipeline is advancing with CLN-619's expansion cohort data in endometrial and cervical cancers expected in Q2 2025, and zipalertinib's pivotal Phase 2b study completed enrollment ahead of schedule. Financial highlights include cash position of $639.0 million, R&D expenses of $35.5 million, and a net loss of $40.6 million ($0.69 per share) for Q3 2024.
Cullinan Therapeutics (Nasdaq: CGEM) announced its participation in the Stifel 2024 Healthcare Conference in New York. The company's CEO Nadim Ahmed and CMO Jeffrey Jones will engage in a fireside chat on Tuesday, November 19, 2024, at 1:50 p.m. ET. The event will be accessible via webcast through the company's investor relations website under the Events and Presentations section. Cullinan is a biopharmaceutical company that specializes in developing modality-agnostic targeted therapies.
Cullinan Therapeutics announced upcoming presentation of preclinical data for CLN-978, a CD19xCD3 bispecific T cell engager, at ACR Convergence 2024 in Washington, D.C. The data demonstrates CLN-978's high potency in B cell depletion, supporting its development for autoimmune diseases. The company recently received FDA clearance for its Phase 1 clinical trial investigating CLN-978 for systemic lupus erythematosus (SLE) in the U.S., following previous HREC approval in Australia. An investor event featuring management discussions and clinical thought leaders will be held on November 16, 2024.
