enVVeno Medical faces setback as FDA issues negative ruling on VenoValve
FDA Decision: enVVeno Medical received an unfavorable decision from the U.S. FDA regarding its appeal of a not-approvable letter for the VenoValve, which was deemed not to meet safety and effectiveness standards.
Focus on enVVe: CEO Robert Berman indicated that the company will shift its focus to the enVVe, a next-generation transcatheter venous valve, which is ready for human testing and aims to have a different safety profile.
Future Interactions with FDA: The company plans to continue discussions with the FDA regarding enVVe and will provide updates on its progress as it seeks alignment on achievable endpoints.
Financial Status: enVVeno Medical reported $31.5 million in cash and investments, sufficient to fund operations into 2027, despite a quarterly cash burn of $4 million to $5 million.
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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%.
