American Heart Association

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Cytokinetics announced FDA acceptance of aficamten's NDA for obstructive hypertrophic cardiomyopathy, with a PDUFA date set for Sept. 26, 2025. Aficamten, a cardiac myosin inhibitor, showed improvements in exercise capacity and safety in the SEQUOIA-HCM trial.

Esperion Therapeutics Inc. submitted an NDA for bempedoic acid to Japan's Pharmaceuticals and Medical Devices Agency, with H.C. Wainwright maintaining a $16 per share price target, implying a 523% return potential. The drug, part of a multipronged expansion strategy, showed significant LDL-C reduction in Phase 3 trials and additional cardiovascular benefits, supporting its adoption by the physician community.

The FDA's block on flavored e-cigarettes sparked controversy, leading to lawsuits from manufacturers who argue the agency unfairly changed approval requirements. Despite health risks, e-cigarette use among adolescents is rising, prompting FDA concerns over public health. The Supreme Court supports the FDA's decision, emphasizing the need to balance benefits for smokers against risks to youth.

Zerlasiran, an siRNA therapy, demonstrated >80% reductions in Lp(a) levels in ASCVD patients in the ALPACAR-360 trial, supporting its phase 3 development. The therapy targets the LPA gene to reduce Lp(a) production, thereby lowering ASCVD risk.

Cytokinetics announced FDA acceptance of its NDA for aficamten, a cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (HCM), with a PDUFA target date of September 26, 2025. The NDA is supported by SEQUOIA-HCM Phase 3 trial results showing significant exercise capacity improvement with aficamten versus placebo, and positive impacts on clinical outcomes and cardiac biomarkers.

November 2024 saw significant advancements in endocrinology, including phase 2 trial results for MariTide, a bispecific GLP-1 and GIPR agonist showing up to 20% weight loss; a study suggesting over half of US adults qualify for semaglutide treatment; BPROAD trial findings emphasizing cardiovascular benefits of intensive blood pressure control in type 2 diabetes; an FDA advisory committee vote against sotagliflozin in type 1 diabetes; and new data on semaglutide reducing knee osteoarthritis pain in obese patients. Additionally, five new episodes of 'Diabetes Dialogue' provided expert insights into technology, trial data, and real-world perspectives in diabetes care.

Rocket Pharmaceuticals' RP-A501 gene therapy for Danon disease showed sustained LAMP2 protein expression and reduced LV mass index in patients up to 60 months post-treatment, with generally well-tolerated safety profile.

HeartLung Technologies presents AI-CAC™, AutoBMD™, and AI-CVD™ research at RSNA 2024, aiming for early detection of heart disease, lung cancer, and other fatal conditions.