Arcus Biosciences, Inc. has terminated its global Phase 3 STAR-221 study evaluating domvanalimab, an investigational anti-TIGIT antibody, in combination with zimberelimab and chemotherapy for advanced upper gastrointestinal cancers. The discontinuation, announced in partnership with Gilead Sciences, Inc., followed a pre-specified interim overall survival analysis that found no benefit compared to the nivolumab-based control arm. Arcus […]
Nitinotes Ltd. has begun patient enrollment in its pivotal U.S. Investigational Device Exemption study evaluating the EndoZip Automated Suturing System for endoscopic sleeve gastroplasty (ESG). The first procedure in the EASE Clinical Trial was completed at Lenox Hill Hospital | Northwell Health in New York, marking the U.S. debut of the device. This study pits […]
Zealand Pharma A/S and OTR Therapeutics have entered a multi-program strategic collaboration and licensing agreement to develop novel oral small-molecule therapies for metabolic diseases. The deal includes an initial payment of USD 20 million to OTR Therapeutics, which could increase to USD 30 million under predefined conditions. Total consideration may reach approximately USD 2.5 billion, […]
IDEAYA Biosciences has completed targeted full enrollment in its Phase 2/3 OptimUM-02 trial evaluating darovasertib in combination with crizotinib as a first-line treatment for HLA*A2-negative metastatic uveal melanoma. The company aims to support a potential accelerated approval filing in the United States based on median progression-free survival data expected in the first quarter of 2026. […]
Eli Lilly and Company has announced successful topline results from its Phase 3 TRIUMPH-4 clinical trial evaluating retatrutide, a triple hormone receptor agonist, in adults with obesity and knee osteoarthritis. The once-weekly investigational therapy delivered significant dual benefits: an average weight loss of 28.7 percent and a 75.8 percent reduction in joint pain, measured by […]
Biohaven Ltd. presented updated Phase 1 clinical data on BHV-1510, its next-generation Trop2-targeting antibody-drug conjugate, at the 2025 European Society for Medical Oncology (ESMO) Immuno-Oncology Congress in London. The results, derived from a heavily pretreated population with advanced or metastatic solid tumors, showed encouraging response rates across non-small cell lung cancer, endometrial cancer, and urothelial […]
When Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration had approved UPLIZNA (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG), the industry’s attention snapped not just to the therapy’s mechanism but to its twice-yearly maintenance schedule. For patients, this marks a seismic shift away from the exhausting cycle of daily oral immunosuppressants […]
Xtant Medical Holdings, Inc. has launched its next-generation synthetic bone graft, nanOss Strata, in the United States. The graft, built from hydroxycarbonapatite (HCA), is designed to enhance bioactivity and integration in orthopedic and spinal surgeries. This launch follows the company’s strategic exit from non-core spinal implant assets, signaling a renewed focus on its biologics portfolio. […]
TransCode Therapeutics, Inc. and Quantum Leap Healthcare Collaborative have launched a Phase 2a dose-expansion trial of TTX-MC138, an RNA-targeting therapeutic aimed at preventing metastatic recurrence in colorectal cancer patients who are ctDNA-positive after standard curative treatment. The trial is part of the PRE-I-SPY platform and will enroll up to 45 patients in early 2026, led […]
Geneva Private Equity has launched NXXIM, a new AI-powered enterprise medical imaging platform designed to unify radiology, pathology, genomics, and electronic health record data into a single, real-time diagnostic environment. The investment-backed venture will pilot its platform in clinical settings in 2026, aiming to streamline fragmented workflows and reduce time-to-diagnosis for large health systems. What […]
