enVVeno Medical Plunges 76.63% After FDA Rejection

On August 20, 2025, enVVeno Medical experienced a significant drop of 76.63% in pre-market trading, marking a dramatic shift in its stock performance.

The primary catalyst for this dramatic decline was the receipt of a not-approvable letter from the U.S. Food and Drug Administration (FDA) for its Premarket Approval application for VenoValve®. The FDA cited insufficient hemodynamic data and safety concerns as the reasons for the rejection, which has raised significant doubts about the future prospects of the VenoValve product.

This setback from the FDA has had a profound impact on investor confidence, leading to a sharp sell-off in enVVeno Medical's stock. The company's ability to address the FDA's concerns and resubmit a satisfactory application will be crucial in determining its future trajectory. Investors will be closely monitoring enVVeno Medical's next steps and any updates on its regulatory strategy.