What Caused EnVVeno Medical Stock (NVNO) to Drop 70% Today?
FDA Rejection: EnVVeno Medical's VenoValve for treating severe chronic venous insufficiency was rejected by the FDA, which issued a non-approvable letter regarding its Premarket Approval application.
Clinical Data Insufficient: The FDA stated that the clinical data provided, including revised Venous Clinical Severity Score and pain improvement metrics, were not adequate to establish a favorable benefit-risk profile for the device.
Stock Impact: Following the FDA's decision, EnVVeno Medical's stock plummeted 71.84% in pre-market trading, after already dropping 16.12% the previous day, although it remains up 38.74% year-to-date.
Future Plans: The company expressed disappointment and is considering options such as resubmission or appeal, while also planning to develop a non-surgical replacement valve called enVVe.
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enVVeno Medical Approves 1-for-35 Reverse Stock Split, Reducing Shares to 655K
- Reverse Stock Split Decision: enVVeno Medical's board approved a 1-for-35 reverse stock split effective January 20, 2026, reducing outstanding shares from approximately 22.9 million to about 655,000, aiming to enhance share price and attract investor interest.
- Exchange Arrangement: Post-split, the company's common stock will resume trading on the Nasdaq Capital Market under the existing ticker symbol 'NVNO', indicating a strategic move to improve market perception and liquidity.
- Market Reaction: Following the reverse split announcement, enVVeno Medical's stock price fell 19.69% in premarket trading to $0.2761, reflecting negative market sentiment that could impact investor confidence.
- Shareholder Impact: The reverse split will consolidate every 35 shares into one, which may reduce the number of shares held by shareholders in the short term, but the company aims to improve long-term investment appeal through a higher share price.
Gold Drops More Than 2%; Cidara Therapeutics Stock Soars
U.S. Stock Market Performance: U.S. stocks showed mixed results, with the Dow Jones falling 0.44%, while the NASDAQ and S&P 500 rose by 0.59% and 0.27%, respectively. Utilities shares increased slightly, but communication services stocks dropped by 1%.
Notable Company Performances: Spire Inc's shares fell over 2% after reporting larger-than-expected quarterly losses, while Cidara Therapeutics saw a 105% surge in shares following Merck's acquisition announcement.
Commodities Update: Oil prices rose by 1.9% to $59.81, while gold and silver prices fell by 2.2% and 5%, respectively. Copper also saw a decline of 1.1%.
Global Market Trends: European shares declined, with the STOXX 600 down 1.54%, and Asian markets mostly closed lower, highlighted by Japan's Nikkei 225 dropping 1.77%.
