Acadia Pharmaceuticals has announced U.S. Food and Drug Administration approval for DAYBUE STIX (trofinetide) for oral solution, a new powder-based formulation of its existing drug DAYBUE used in the treatment of Rett syndrome. The approval covers use in adult and pediatric patients two years and older and is based on bioequivalence data, not new clinical […]
Merck has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an expanded indication for WINREVAIR (sotatercept) in combination with other therapies for the treatment of pulmonary arterial hypertension (PAH) in adults across WHO Functional Classes II, III, and IV. The update follows pivotal […]
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 […]
Lynk Pharmaceuticals and Formation Bio have entered an exclusive licensing and development agreement for LNK01006, a next-generation, central nervous system (CNS)-penetrant TYK2 inhibitor. The deal gives Formation Bio global rights to the asset outside Greater China, with plans to initiate a Phase 1 clinical trial in the United States during the first half of 2026. […]
Privo Technologies has officially initiated dosing in a Phase 1/2 trial evaluating PRV131, its nanoengineered intratumoral cisplatin injectable, for the treatment of T1–T3 oral squamous cell carcinoma (OSCC). The trial, designated Arm 3 of the CLN-004 study, will explore PRV131 as a neoadjuvant therapy aimed at shrinking tumors before surgery. The announcement marks a pivotal […]
Senhwa Biosciences Inc. and BeOne Medicines have signed a clinical supply agreement to explore a novel drug combination aimed at treating hard-to-reach cancers. The collaboration will test Senhwa’s lead compound Pidnarulex (CX-5461), a G-quadruplex stabilizer, in combination with BeOne’s PD-1 inhibitor tislelizumab. The Phase 1b/2a clinical trial will enroll patients with advanced solid tumors, including […]
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, […]
Lee’s Pharmaceutical Holdings Limited has acquired the Staccato One Breath Technology platform and related assets from Alexza Pharmaceuticals, gaining exclusive rights to manufacture and license Staccato alprazolam under its global agreement with UCB. The transaction expands Lee’s Pharmaceutical’s inhalation drug delivery pipeline, deepens its foothold in central nervous system therapies, and positions the company to […]
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. […]
Bio-Techne Corporation has announced a strategic partnership with the Wyss Center for Bio and Neuroengineering in Geneva to develop an automated platform for simultaneous RNA and protein detection in 3D tissue samples. The collaboration aims to reduce technical complexity and accelerate adoption of spatial biology tools by enabling high-resolution multiomic analysis in intact three-dimensional specimens. […]