U.S. stocks traded lower this morning, with the Nasdaq Composite falling more than 200 points on Friday.Following the market opening Friday, the Dow traded down 1.21% to 46,882.86 while the NASDAQ fell 1.51% to 22,525.90. The S&P 500 also fell, dropping, 1.17% to 6,658.51.Check This Out: Top 2 Financial Stocks That May Plunge This QuarterLeading and Lagging SectorsReal estate shares jumped by 0.3% on Friday.In trading on Friday, information technology stocks fell by 1.2%.Top HeadlineApplied Materials Inc (N ...

- Cash and investments are sufficient to fund current operations through Q2 2027, not including VenoValve commercialization and the enVVe IDE study - Cash burn of $4.2 million in Q3 remains in line with projected quarterly range - Ongoing engagement with FDA for supervisory appeal of the VenoValve PMA decision with feedback expected by the end of 2025 IRVINE, CA / ACCESS Newswire / October 31, 2025 / enVVeno Medical Corporation (Nasdaq:NVNO) ("enVVeno Medical" or the "Company"), a company setting new standa ...

股价表现 - enVVeno Medical股价自8月19日以来暴跌76.1% 主要由于FDA对VenoValve的上市前批准申请发出不可批准信函[1] - 公司股价年初至今下跌66.9% 远逊于行业6.7%的跌幅和标普500指数9.8%的涨幅[4] - 股价压力可能持续至公司解决FDA提出的问题[5] FDA审批决定 - FDA认为SAVVE研究数据不足以证明VenoValve手术置换静脉瓣膜的获益风险比优势[2][9] - 尽管SAVVE研究显示高比例既往标准治疗失败患者接受VenoValve后出现显著临床改善[6] - FDA指出临床改善可能源于患者参与研究本身 并关注开放式手术安全性问题导致再住院风险[10] 财务影响 - 公司季度现金消耗为400-500万美元 现有资金预计可支撑运营至2026年第三季度[5] - FDA不可批准决定可能延迟VenoValve商业化进程 影响公司收入生成能力[5] 产品管线进展 - VenoValve是公司最先进的管线候选产品 用于治疗严重深静脉慢性功能不全[3] - 公司正在开发非手术经导管置换静脉瓣膜enVVe 已完成6个月临床前GLP研究[12] - 计划未来数月提交enVVe关键研究的试验用器械豁免申请[8][12] 后续行动 - 公司正在审阅FDA反馈 可能要求会讨论VenoValve重新提交或申诉事宜[11] - enVVe的试验用器械豁免申请若获FDA批准可能成为股价复苏催化剂[12]