enVVeno Crashes 70% After FDA Rejects VenoValve® PMA
enVVeno Medical Corp. (NVNO) plunged 70.21% to lead declines in the PRISM Emerging Healthcare Index, after the FDA issued a “not-approvable” letter for its VenoValve® Premarket Approval application. While clinical data showed improvements in pain scores, venous quality-of-life measures, and the revised Venous Clinical Severity Score (rVCSS), regulators cited the absence of a hemodynamic measurement to confirm benefit and raised safety concerns tied to the open surgical procedure.
The company said it will review all options, including a potential resubmission or appeal, while advancing enVVe®, its non-surgical replacement venous valve, which is preparing for a pivotal trial.
enCore Energy Slides 17% on $100M Convertible Notes Offering
Shares of enCore Energy Corp. (EU) fell 16.67%, dragging the PRISM Emerging New Energy Index lower, after the company priced an upsized $100 million offering of 5.5% Convertible Senior Notes due 2030. The offering, increased from $75M, includes a capped call structure designed to limit dilution, but concerns over shareholder impact outweighed optimism around the financing.
Other PRISM Mid-Day Movers:
- Trinity Biotech plc (TRIB) up 24.09%
- Gaxos.ai Inc. (GXAI) down 17.23%
- ETHZilla Corporation (ETHZ) down 16.19%
The post PRISM Mid-Day Movers: FDA Setbacks and Convertible Note Pressure appeared first on PRISM MarketView.
