Kingdon group disclosed a passive holding in enVVeno Medical Corporation (NVNO). The filing reports that Kingdon Capital Management, L.L.C. and affiliated entities and individual Mark Kingdon together hold shared voting and dispositive power over 1,359,261 shares, representing 7.1% of the outstanding common stock. M. Kingdon Offshore Master Fund, L.P. and Kingdon GP, LLC each report 1,265,845 shares (6.6%). The filing states the securities are owned by advisory clients and were not acquired to change or influence control of the issuer. Signatures from authorized representatives and exhibits (Joint Filing Agreement and Control Person Identification) are attached.
enVVeno Medical Corporation reported that it received a not approvable letter from the U.S. Food & Drug Administration regarding its Premarket Approval application for VenoValve, a surgical replacement venous valve intended to treat severe deep chronic venous insufficiency. This means the FDA has determined the application cannot be approved in its current form. The company disclosed this development through a press release attached to the report.
enVVeno also reminded readers that statements about future events, including those related to its clinical trials, are forward-looking and subject to significant risks and uncertainties described in its other SEC reports.