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CAMBRIDGE, Mass. - Cullinan Therapeutics, Inc. (NASDAQ: CGEM), a biopharmaceutical company with a market capitalization of $456 million, announced today that the European Medicines Agency (EMA) has approved its Clinical Trial Application (CTA) for the drug candidate CLN-978. The Phase 1 clinical trial, slated to begin in Q2 2025, will evaluate the safety and efficacy of CLN-978 in patients with active, difficult-to-treat rheumatoid arthritis. According to InvestingPro data, the company maintains a strong financial position with more cash than debt and a healthy current ratio of 13.5.
The trial will take place at leading research institutions including FAU Erlangen-Nuremberg in Germany and Università Cattolica del Sacro Cuore in Rome. It aims to assess the drug’s safety profile, pharmacokinetics, pharmacodynamics, and its impact on disease activity in patients who meet the 2010 American College of Rheumatology/European Alliance of Associations for Rheumatology Classification Criteria. The announcement comes as Cullinan’s stock trades near $7.80, significantly below its 52-week high of $30.19, potentially presenting an opportunity as InvestingPro analysis suggests the stock is currently undervalued.
CLN-978 is a novel CD19xCD3 bispecific T cell engager, designed to target B cells, including those with low CD19 expression levels. The drug is also being studied globally for systemic lupus erythematosus, with trials ongoing in the U.S., Europe, and Australia. According to Jeffrey Jones, MD, MBA, Chief Medical Officer at Cullinan Therapeutics, CLN-978 is the only CD19-targeting T cell engager advancing a global regulatory development plan that includes a U.S. FDA-cleared IND.
Rheumatoid arthritis affects millions worldwide and presents a significant treatment challenge. Despite the availability of disease-modifying antirheumatic drugs (DMARDs), many patients do not achieve remission or become refractory to treatment. Ricardo Grieshaber-Bouyer, MD, PhD, MHBA, Professor of Clinical Systems Immunology and Head of the Clinical Trials Unit at FAU Erlangen-Nuremberg, and global Principal Investigator for the trial, underscored the need for novel treatments like CLN-978 that could potentially offer deeper B cell depletion than existing therapies.
Cullinan Therapeutics focuses on creating new standards of care for patients, with a diversified portfolio of clinical-stage assets aimed at both autoimmune diseases and cancer. The company emphasizes the fast-tracking of promising molecules to the clinic and ultimately commercialization. While analysts maintain a bullish outlook with price targets ranging from $29 to $36, investors should note that InvestingPro subscribers have access to over 8 additional key insights about Cullinan’s financial health and market position.
The information presented in this article is based on a press release statement from Cullinan Therapeutics.
In other recent news, Cullinan Oncology has seen significant developments following the announcement that its Phase 2b REZILIENT1 trial met its primary endpoint. This trial focuses on the effectiveness of zipalertinib as a monotherapy for patients with non-small cell lung cancer who have specific genetic mutations. The successful results demonstrated that the primary endpoint of overall response rate was achieved, with the safety profile aligning with previous data. As a result, H.C. Wainwright raised its price target for Cullinan Oncology to $33.00 from $28.00, maintaining a Buy rating on the company’s shares. The firm’s analysts anticipate zipalertinib could potentially be launched in 2026 with an initial sales projection of $41 million. Cullinan Oncology, in collaboration with Taiho Pharmaceutical, plans to discuss regulatory approval with the FDA in the second half of 2025. Additionally, the company is conducting further studies, including the pivotal REZILIENT3 study and the parallel cohort study REZILIENT2, both of which are ongoing. Full results from the REZILIENT1 trial are expected to be presented at a medical conference in mid-2025.
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