$EW

Edwards Lifesciences (EW) announced positive one-year results from the CLASP II TR trial, showing 80% of patients treated with the PASCAL system had moderate or less valve leakage, compared to 30% on medication alone. The data, presented at TCT, demonstrated reduced tricuspid regurgitation and improved health status. The PASCAL system received FDA approval in October 2026 and CE Mark in 2020, with thousands of patients treated worldwide.

Edwards Lifesciences' PROGRESS Trial showed TAVR reduced heart failure hospitalizations by 50% vs. monitoring. TAVR also improved quality of life and safety. The trial involved 744 patients with moderate aortic stenosis. Edwards' SAPIEN 3 valve was used. Results published in NEJM.

Edwards Lifesciences (EW) received FDA approval for its PASCAL Precision System to treat tricuspid valve disease, expanding its heart valve therapy portfolio. The system offers a minimally invasive option for patients with severe tricuspid regurgitation. EW stock is up 0.73%, trading at $88.90.

The FDA issued a safety alert for Edwards Lifesciences' Sapien M3 valve delivery systems after three balloon bursts, including one death. Edwards advised customers to return affected devices. Shares (NYSE: EW) fell 1.3% to $86.94 since the Oct. 15 alert.

HHS staff concerns over 6,000-word self-assessment; former FDA chiefs criticized Trump admin's RIF efforts. FDA nominee Heidi Overton influenced CDC vaccine reduction. FDA finalized blood donation guidances, added opioid use disorder videos. Altor BioScience's Anktiva got expanded approval; Alcon's Brytly eye drops approved. Par Health recalled argatroban injection. FDA issued recalls/alerts for Medline, Edwards Lifesciences products.

The FDA issued a high-risk alert for Edwards Lifesciences' SAPIEN M3 mitral valve delivery system, linked to one death and one injury due to balloon bursts. The agency advised removing affected lots. Edwards' system, approved in December 2025, treats mitral regurgitation in high-risk patients. The company previously faced a 2019 recall for a similar issue.

UBS reiterated a Buy rating on Edwards Lifesciences (NYSE:EW) with a $110.00 price target, citing endpoint expectations. The stock trades at a P/E of 49.59, but is considered undervalued. Recent Q2 results showed $1.74B in sales, up 12.5%, and EPS of $0.78. Analysts have mixed views on the stock's outlook.

The FDA approved Edwards Lifesciences' Autus Size-Adjustable Valve, the first heart valve designed to expand with a child's growth, for pediatric patients with congenital pulmonary valve disease. The valve can be implanted at 13 mm and expanded to 22 mm, potentially reducing repeat open-heart surgeries. The approval was based on a pivotal trial with 62 patients, showing acceptable hemodynamic performance and no major complications at 6 months.

FDA nominee Heidi Overton's confirmation vote delayed until after midterms. FDA reinstated advisory committees and updated safety monitoring. Two individuals charged in counterfeit Ozempic scheme. Egetis' Emcitate and BMS's Camzyos received approvals. PhRMA to welcome new CEO Eric Cantor. FDA adopted new data standards and updated forms. CDRH met MDUFA V commitments. Autus Valve approved for pediatric use.

Edwards Lifesciences (EW) received FDA approval for a pediatric heart valve. Ceribell (CBLL) and SI-BONE (SIBN) cleared new software and spinal fusion systems. Teva (TEVA) added a biosimilar to its portfolio. AbbVie (ABBV) and Mirum (MIRM) gained FDA approvals for Parkinson's and rare disease treatments. Merck (MRK) withdrew a lung cancer drug filing. Sanofi (SNY) and Regeneron (REGN) expanded their immunology alliance.