EnVVeno Medical (NVNO) stock took a beating after the medical device company’s VenoValve surgical replacement venous valve for severe deep chronic venous insufficiency was rejected by the U.S. Food and Drug Administration (FDA). The FDA sent a non-approvable letter to EnVVeno Medical, stating it couldn’t approve the Premarket Approval application for the product in its current form.
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According to EnVVeno Medical, the FDA wouldn’t approve the medical device because “the favorable revised Venous Clinical Severity Score (rVCSS) data generated by the study to show clinical improvement, together with the improvements in pain scores and venous specific quality of life indicators was not sufficient on its own to determine favorability of the benefit risk profile for the VenoValve.”
EnVVeno Medical noted its disappointment with the FDA’s decision and is weighing options, including a potential resubmission or appeal. The company also said that it will take into account what it has learned from this letter in its development of enVVe a non-surgical replacement venous valve that it plans to submit an IDE application for.
EnVVeno Medical Stock Movement Today
EnVVeno Medical stock was down 71.84% in pre-market trading, following a 16.12% drop yesterday. The shares were still up 38.74% year-to-date but were down 20.94% over the past 12 months. Today’s news came with heavy trading, as some 3.6 million shares changed hands, compared to a three-month daily average of about 148,000 units.
Is EnVVeno Medical Stock a Buy, Sell, or Hold?
Turning to Wall Street, coverage of EnVVeno Medical is thin. Fortunately, TipRanks’ AI analyst Spark has it covered. Spark rates NVNO stock a Neutral (58) with no price target. It cites “robust technical performance, which is somewhat overshadowed by challenging financial metrics” as reasons for this stance.
