NASDAQ — Healthcare: Manufacturing, Biotechnology: Pharmaceutical Preparations
www.regeneron.comRegeneron will present 18 studies on oncology and hematology, including updates on Libtayo and linvoseltamab, from May 30 to June 3, 2025, in Chicago, IL.
conference talkResults from the Phase 3 C-POST trial evaluating Libtayo in high-risk cutaneous squamous cell carcinoma will be presented on May 31, 2025.
clinical readoutRegeneron will present results from the LINKER-MM2 trial on June 2, 2025, focusing on linvoseltamab combinations in relapsed/refractory multiple myeloma.
clinical readoutResults from a Phase 2 trial of vidutolimod in stage 3 resectable melanoma will be presented on June 3, 2025.
clinical readoutA phase Ib clinical trial evaluating ASP8374 (an anti-TIGIT antibody, investigational, Astellas) in combination with cemiplimab (PD-1 inhibitor, Regeneron) for recurrent malignant glioma is expected to complete on June 30, 2025. The multicenter, randomized, open-label study, sponsored by Dana-Farber Cancer Institute, aims to determine the maximum tolerated dose and assess safety and preliminary efficacy. ASP8374 is not FDA-approved for any indication; cemiplimab is approved for other cancers but not glioma. The trial involves up to 24 participants and is supported by Astellas and Regeneron.
trial completionThe FDA has accepted the Biologics License Application for linvoseltamab in adults with relapsed/refractory multiple myeloma, with a target action date set for July 10, 2025.
fda decisionThe FDA has set target action dates for linvoseltamab and odronextamab on July 10, 2025, and July 30, 2025, respectively.
fda decisionThe FDA will decide on the application for odronextamab on July 30, 2025, following its review.
fda decisionA Phase 1/2 clinical trial evaluating Cemiplimab, an anti-PD-1 antibody marketed as Libtayo by Regeneron, alone and in combination with RP1, an oncolytic HSV-1 therapy from Replimune, for advanced squamous skin cancer is expected to complete by September 1, 2025. The study, sponsored by Replimune, is assessing safety and efficacy in patients with advanced malignancies. The trial is currently active but not recruiting.
trial completionVyriad is expected to complete a Phase 2 clinical trial of Voyager V1 in combination with Regeneron's anti-PD-1 antibody cemiplimab for cancer treatment on December 1, 2025. The study, enrolling 87 patients, evaluates the efficacy and safety of intratumoral Voyager V1 with intravenous cemiplimab across three cancer cohorts. Cemiplimab (Libtayo) is an FDA-approved immunotherapy for certain cancers, and Voyager V1 is an investigational oncolytic virus therapy. The trial uses a Simon's two-stage design to assess clinical benefit and toxicity.
trial completion