enVVeno (NVNO) Plunges 3.75% to Record Low Following FDA Rejection of VenoValve

enVVeno Medical (NVNO) shares plunged to a record low on August 28, 2025, with an intraday decline of 5.56%, marking a continuation of its steep sell-off following regulatory setbacks. The stock closed the day down 3.75%, reflecting persistent investor pessimism after a series of challenges to its core product pipeline.

The FDA’s rejection of enVVeno’s VenoValve, its flagship device for treating chronic venous insufficiency, remains the primary catalyst for the selloff. The agency’s “Not Approvable” letter in late August 2025 highlighted unresolved regulatory concerns, effectively stalling the product’s commercialization. The VenoValve had been the company’s sole path to revenue, and the setback has left enVVeno with no near-term alternatives, exacerbating doubts about its long-term viability.

Financial metrics underscore the company’s fragility. Quarterly earnings of ($0.33) per share missed estimates, and projected losses remain stubbornly high. A negative P/E ratio and a P/B ratio of 0.54 signal deep undervaluation and limited profitability prospects. With no dividend history and a lack of diversified product development, enVVeno’s growth is entirely tied to overcoming FDA hurdles—a scenario that appears distant given its current trajectory.

Short interest has surged by 18% in the past month, with a days-to-cover ratio of 4.5, indicating mounting bearish sentiment. Institutional ownership at 34.71% remains low, reflecting a lack of confidence from large investors. Meanwhile, insider inactivity over the past three months suggests no internal efforts to stabilize the stock, compounding volatility. Negative news sentiment, driven by the FDA rejection and weak earnings, has further eroded market trust.

Despite a 700% spike in search interest for NVNO, the stock’s inclusion in “Top Stock Losers” and its 12th percentile ranking in the medical sector highlight its struggling position. For enVVeno to regain traction, it must address regulatory concerns, demonstrate progress in clinical trials, and rebuild credibility. Until then, the stock remains highly susceptible to further declines amid a lack of catalysts and a bleak near-term outlook.