Caliway's Fat Reduction Drug Candidate CBL-514 Completes U.S. FDA IND Submission for Phase 2 Clinical Study in Weight Management, Expanding Development Combined with GLP-1RA-Based Weight-Loss Therapies
Caliway has completed submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 2 clinical study of CBL-514 for weight management (CBL-0201WR Phase 2). The study will evaluate CBL-514 in...
Rona Therapeutics Unveils the Global First Bi-valent PCSK9-LPA siRNA into Clinical Development for Cardiovascular Risk Reduction
SHANGHAI and SANTA BARBARA, Calif., Dec. 17, 2025 /PRNewswire/ -- Rona Therapeutics, a global leader in next-generation RNAi medicines, today announced the submission of RN5681 to the Australian Human Research Ethics Committee (HREC), advancing the...
Lunit Submits 510(k) Application for Image-Based Breast Cancer Risk Prediction Model
Submission marks a key regulatory milestone toward bringing SEER-calibrated, imaging-based risk assessment to U.S. screening programs SEOUL, South Korea, Dec. 8, 2025 /PRNewswire/ -- Lunit (KRX:328130), a leading provider of AI for cancer...
Ascletis Selects a Best-in-Class Once-Monthly Subcutaneously Administered Amylin Receptor Agonist, ASC36, for Clinical Development
-In head-to-head non-human primate (NHP) studies, average observed half-life of ASC36 was approximately 15 days, 3 -fold longer than petrelintide, which supports once-monthly subcutaneous (SQ) dosing in humans. -ASC36 demonstrated approximately 91 %...
CStone Announces Submission of Clinical Trial Application in Australia for CS2009, an Innovative PD-1/VEGF/CTLA-4 Trispecific Antibody
SHANGHAI, Dec. 23, 2024 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, announced today the submission of clinical trial...