A phase 3 trial shows that the oral drug enlicitide reduces LDL cholesterol by 60% compared to placebo, according to results published in the New England Journal of Medicine. Sponsored by Merck & Co., the trial involved 2,909 participants with atherosclerosis or at risk. If approved, enlicitide could help lower heart attack and stroke risk.
Regeneron announced FDA and EMA review acceptance for cemdisiran in generalized myasthenia gravis and FDA priority review acceptance for garetosmab in fibrodysplasia ossificans progressiva. The garetosmab BLA is supported by Phase 3 OPTIMA trial data showing 94% and 90% reductions in new bone lesions.
A French cohort study found nirsevimab at birth reduces RSV-related hospitalizations in infants by 22% compared to maternal vaccination. UK data shows the maternal RSV vaccine provides over 80% protection when given at least four weeks before birth. Both strategies aim to protect vulnerable infants during their first months of life.
Biotech stocks Ocugen, Kodiak Sciences, and CytoDyn are experiencing market movements driven by clinical data and regulatory milestones, particularly Biologics License Application (BLA) filings. Ocugen saw a surge in short interest, Kodiak reached a 52-week high on positive trial results, and CytoDyn's stock remains volatile as it advances its monoclonal antibody pipeline.
A Cleveland Clinic study found no racial survival disparities in multiple myeloma when patients have equal access to modern therapies. Clinical cases demonstrate long-term remission with second stem cell transplants and targeted agents like daratumumab.
The phase III frontMIND trial showed that adding tafasitamab and lenalidomide to R-CHOP chemotherapy reduced the risk of progression by 25% in patients with high-risk B-cell lymphomas. The 3-year progression-free survival was 67.3% with the combination versus 60.7% with R-CHOP alone. A dual-targeted CD19/CD20 immunotherapy regimen has also been approved in Australia for relapsed follicular lymphoma.
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's Enflonsia (clesrovimab) receives EU approval for RSV prevention in infants. Separately, researchers identify a monoclonal antibody cocktail from pediatricians' immune cells that shows potent protection against RSV and hMPV in animal studies.
Phase 3 trial data show daratumumab reduced relapse risk by 74% in NMOSD. Separately, the FDA accepted an NDA for iberdomide plus daratumumab/dexamethasone in relapsed/refractory multiple myeloma, with a PDUFA date of August 17, 2026.
MIT chemical engineers used a large language model to optimize protein production in industrial yeast. The AI model improved yields for five of six tested proteins, including a cancer monoclonal antibody, potentially reducing drug development costs.
