enVVeno Medical Plunges 71.6% After FDA Rejection

On August 20, 2025, enVVeno Medical experienced a significant drop of 71.6% in pre-market trading.

enVVeno Medical Corporation received a not-approvable letter from the U.S. Food and Drug Administration for its VenoValve surgical device. The FDA cited insufficient hemodynamic data and safety concerns as the primary reasons for the rejection. This decision has had a substantial impact on the company's stock performance, leading to a sharp decline in investor confidence.

The not-approvable letter from the FDA is a major setback for enVVeno Medical, as it indicates that the regulatory body has significant reservations about the safety and efficacy of the VenoValve device. This news has raised concerns among investors about the company's ability to navigate the regulatory landscape and bring its products to market successfully.