NervGen Secures FDA Alignment for Mid-2026 NVG-291 RESTORE Trial
NervGen completed an FDA End-of-Phase 2 meeting, obtaining alignment on RESTORE registrational study parameters for NVG-291 in chronic tetraplegia and activating sites for a mid-2026 trial start. Independent, blinded biomechanical gait analyses from the Phase 1b/2a CONNECT SCI study are ongoing, with results expected in Q2 2026.
1. FDA Alignment and RESTORE Trial Progress
NervGen completed an FDA End-of-Phase 2 meeting for NVG-291 in chronic tetraplegia, securing agreement on RESTORE registrational study parameters. Site activation is underway and the trial is on track to initiate in mid-2026.
2. Ongoing CONNECT SCI Biomechanical Gait Analyses
Independent, blinded biomechanical gait analyses in the Phase 1b/2a CONNECT SCI study remain ongoing, using coordination, mechanical effort and postural stability measures to distinguish genuine neural recovery from compensatory movement. Results are anticipated in the second quarter of 2026.
3. Nasdaq Listing and Leadership Strengthening
Since listing on Nasdaq on January 8, 2026, NervGen has bolstered its leadership team with three senior hires: Dr. Keith Vendola as CFO, Shamim Ruff as Chief Regulatory Affairs Officer and Christine McSherry as SVP of Patient Advocacy & Clinical Affairs to support late-stage development efforts.