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%.
Nasdaq Falls by More Than 300 Points; Applied Materials Reports Positive Q4 Earnings
Market Performance: U.S. stocks opened lower, with the Dow down 1.21%, Nasdaq falling 1.51%, and S&P 500 decreasing by 1.17%. European and Asian markets also experienced declines.
Sector Movements: Real estate shares rose by 0.3%, while information technology stocks fell by 1.2%. Notable stock movements included Cidara Therapeutics surging 106% after a Merck acquisition announcement.
Company Earnings: Applied Materials reported better-than-expected fourth-quarter results and projected first-quarter revenue above estimates, while several companies, including Gauzy Ltd and enVVeno Medical Corp, faced significant stock declines.
Commodity Updates: Oil prices increased by 1.9% to $59.82, while gold and silver prices fell by 3.4% and 5%, respectively. Economic data on oil rig counts is expected to be released today.
RLX Technology Shares Rise 6%; Check Out 20 Stocks Making Moves in Premarket Trading
RLX Technology Inc Performance: RLX Technology's shares rose 6% to $2.47 in pre-market trading after reporting third-quarter earnings of 3 cents per share and $158.6 million in sales.
Notable Gainers: Cidara Therapeutics surged 92% to $203.50 following a significant ownership disclosure, while other companies like Binah Capital Group and Expion360 also saw substantial pre-market gains.
Significant Losers: TSS Inc experienced a 40.2% drop to $9.10 after reporting a year-over-year decline in financial results, with enVVeno Medical Corp and Nuvve Holding Corp also facing significant losses.
Market Overview: The pre-market trading session showed a mix of gains and losses among various stocks, reflecting varied financial performances and investor reactions to earnings reports.
Nasdaq Declines 1%; Lowe's Reports Positive Earnings
U.S. Stock Market Performance: U.S. stocks declined mid-session, with the Nasdaq Composite dropping over 200 points and the S&P 500 and Dow also experiencing losses.
Lowe's Earnings Report: Lowe's Companies reported better-than-expected second-quarter earnings, with adjusted EPS rising to $4.33 and quarterly sales reaching $23.96 billion, prompting an update in fiscal guidance.
Equities Movement: NovaBay Pharmaceuticals saw a significant stock increase of 68% after a securities purchase agreement, while enVVeno Medical Corporation shares plummeted 72% following FDA news.
Global Market Trends: European shares showed mixed results, Asian markets closed mixed with Japan's Nikkei falling, and U.S. mortgage applications decreased by 1.4% from the previous week.
Wednesday's Major Stock Market Highlights: Morning News Summary!
Stock Market Highlights: The article discusses the major stock market stories from Wednesday, emphasizing significant news that investors should pay attention to.
TipRanks Coverage: TipRanks has curated a selection of the most relevant and impactful stock market news for readers.
Market Trends: The content suggests that there are various trends and developments in the stock market worth exploring further.
Disclaimer: A disclaimer is included, indicating the information is based on data available up to October 2023.
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%.
Nasdaq Falls by More Than 300 Points; Applied Materials Reports Positive Q4 Earnings
Market Performance: U.S. stocks opened lower, with the Dow down 1.21%, Nasdaq falling 1.51%, and S&P 500 decreasing by 1.17%. European and Asian markets also experienced declines.
Sector Movements: Real estate shares rose by 0.3%, while information technology stocks fell by 1.2%. Notable stock movements included Cidara Therapeutics surging 106% after a Merck acquisition announcement.
Company Earnings: Applied Materials reported better-than-expected fourth-quarter results and projected first-quarter revenue above estimates, while several companies, including Gauzy Ltd and enVVeno Medical Corp, faced significant stock declines.
Commodity Updates: Oil prices increased by 1.9% to $59.82, while gold and silver prices fell by 3.4% and 5%, respectively. Economic data on oil rig counts is expected to be released today.
RLX Technology Shares Rise 6%; Check Out 20 Stocks Making Moves in Premarket Trading
RLX Technology Inc Performance: RLX Technology's shares rose 6% to $2.47 in pre-market trading after reporting third-quarter earnings of 3 cents per share and $158.6 million in sales.
Notable Gainers: Cidara Therapeutics surged 92% to $203.50 following a significant ownership disclosure, while other companies like Binah Capital Group and Expion360 also saw substantial pre-market gains.
Significant Losers: TSS Inc experienced a 40.2% drop to $9.10 after reporting a year-over-year decline in financial results, with enVVeno Medical Corp and Nuvve Holding Corp also facing significant losses.
Market Overview: The pre-market trading session showed a mix of gains and losses among various stocks, reflecting varied financial performances and investor reactions to earnings reports.
Nasdaq Declines 1%; Lowe's Reports Positive Earnings
U.S. Stock Market Performance: U.S. stocks declined mid-session, with the Nasdaq Composite dropping over 200 points and the S&P 500 and Dow also experiencing losses.
Lowe's Earnings Report: Lowe's Companies reported better-than-expected second-quarter earnings, with adjusted EPS rising to $4.33 and quarterly sales reaching $23.96 billion, prompting an update in fiscal guidance.
Equities Movement: NovaBay Pharmaceuticals saw a significant stock increase of 68% after a securities purchase agreement, while enVVeno Medical Corporation shares plummeted 72% following FDA news.
Global Market Trends: European shares showed mixed results, Asian markets closed mixed with Japan's Nikkei falling, and U.S. mortgage applications decreased by 1.4% from the previous week.
Wednesday's Major Stock Market Highlights: Morning News Summary!
Stock Market Highlights: The article discusses the major stock market stories from Wednesday, emphasizing significant news that investors should pay attention to.
TipRanks Coverage: TipRanks has curated a selection of the most relevant and impactful stock market news for readers.
Market Trends: The content suggests that there are various trends and developments in the stock market worth exploring further.
Disclaimer: A disclaimer is included, indicating the information is based on data available up to October 2023.
