Edwards Lifesciences stock gets FDA approval for AUTUS valve

Published on 10/04/2026 at 21:37 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

Edwards Lifesciences stock gets FDA approval for AUTUS on October 1, 2026. Q2 revenue reached USD 1.74 billion, up 13.6 percent year over year.

Architektonisches CGI-Render eines modernen Medizintechnik-Produktionsgebäudes bei Dämmerung — Edwards Lifesciences US28176E1082 Architektur-Render des modernen Medizintechnik-Fertigungsgebäudes bei Dämmerung mit Spiegelteich und Glasfassade, Illustration mit AI erstellt.

Edwards Lifesciences stock (ISIN US28176E1082) closed at USD 85.15 on the NYSE on October 2, 2026, down 0.05 percent from USD 85.19. The company received FDA approval for its AUTUS pediatric pulmonary valve on October 1, 2026, a product event that expands its structural heart portfolio.

AUTUS wins FDA approval

According to Edwards Lifesciences on October 1, 2026, the FDA approved AUTUS as a surgical pulmonary valve for pediatric patients with congenital heart disease.

The valve can be expanded through a minimally invasive transcatheter procedure as a child grows. The pivotal study reported 100 percent of patients free from device-related complications through 30 days, while patients will continue to receive follow-up for 10 years.

Second-quarter growth sets the base

MarketBeat reported that Edwards posted USD 1.74 billion in second-quarter 2026 revenue, up 13.6 percent from the prior-year quarter, while adjusted EPS reached USD 0.78 versus a USD 0.74 consensus estimate.

The same report listed third-quarter 2026 adjusted EPS guidance of USD 0.71-0.77 and full-year 2026 guidance of USD 2.95-3.05. That combination puts the AUTUS approval against a business already delivering double-digit quarterly sales growth.

Analysts see upside to USD 100.27

MarketBeat said 17 of 23 covering analysts rated the stock Buy, while six recommended Hold, producing a Moderate Buy consensus and an average 12-month target of USD 100.27.

Against the October 2 closing price of USD 85.15, that consensus target lies 17.8 percent above the price. The market is therefore weighing a fresh pediatric product approval against a valuation that already assumes continued execution in structural heart therapies.

Stock closed near the middle of its range

Edwards Lifesciences closed at USD 85.15 on the NYSE on October 2, 2026. The session range was USD 84.66-86.48, the 52-week range was USD 72.30-96.29, volume was 2,401,080 shares and market capitalization was USD 49.1 billion.