NewAmsterdam Pharma said regulatory decisions on obicetrapib in Europe, the UK and Switzerland remain expected in 2H26. PREVAIL interim analysis is planned for 4Q2026, with a result expected in 1Q2027.
BrightGene Bio-Medical reported Phase III data for BGM0504 showing 19.3% mean weight reduction and improvements in blood pressure, lipids and uric acid. The data highlighted GIP as a key variable in broader metabolic management.
LIB Therapeutics launched Lerochol in the United States after FDA approval for lowering LDL-C in adults with hypercholesterolemia, including HeFH. The once-monthly PCSK9 inhibitor is available with a $199-per-month cash-pay option.
Merck will present late-breaking clinical data from its cardio-pulmonary pipeline at ACC.26, including positive Phase 3 results for enlicitide, an investigational oral PCSK9 inhibitor, and Phase 2 data for WINREVAIR in heart failure patients.
Three new CRISPR-based therapies show promise for treating heart failure through mitochondrial enhancement, cystic fibrosis via lipid nanoparticle gene insertion, and elevated cholesterol with single-dose gene editing targeting ANGPTL3.
Enlicitide decanoate demonstrated efficacy in reducing LDL cholesterol levels compared to placebo in patients with atherosclerotic cardiovascular disease history or risk, according to phase 3 CORALreef Lipids trial data.
The global CRISPR and prime editing market is forecast to grow at 24.1% CAGR through 2031, driven by therapeutic advances and regulatory progress. Scribe Therapeutics achieved a second milestone with Eli Lilly, while new RNA production and gene editing technologies accelerate research.
The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.
