enVVeno Medical shares fall 34.03% after-hours after FDA upholds not-approvable decision for VenoValve device.

enVVeno Medical (NASDAQ:NVNO) fell 34.03% in after-hours trading following the FDA’s decision to uphold its not-approvable stance on the VenoValve device for treating severe chronic venous insufficiency. The agency maintained that the surgical valve failed to meet safety and effectiveness standards, despite the company’s appeal. This regulatory setback prompted enVVeno to pivot to its next-generation transcatheter valve, enVVe, which is now ready for human testing. The stock’s sharp decline aligned with the FDA’s reaffirmed rejection, overshadowing the company’s $31.5 million cash reserves and projected operational runway through 2027. Technical analyses and liquidity factors cited in some reports were secondary to the core regulatory adverse event driving the sell-off.