NervGen Pharma (NASDAQ: NGEN) has announced the completion of a successful end-of-Phase 2 (EOP2) meeting with the FDA and alignment on RESTORE, the company’s Phase 3 registrational study designed to evaluate NVG-291 for chronic tetraplegia.
According to NervGen, the RESTORE registrational study remains on-track for initiation in mid-2026.
In a statement, Adam Rogers, MD, president and CEO of NervGen, commented, “We are grateful for the continued and collaborative partnership with the FDA. RESTORE’s design, anchored by the strength and totality of the CONNECT SCI data, was shaped in close collaboration with the FDA, the SCI community, key opinion leaders, and advocates, to ensure the clinical data and outcomes generated reflect what matters most to the individuals it’s designed to serve. We are working tirelessly and advancing with urgency to continue developing a potentially life-changing therapy for individuals with chronic tetraplegia.”
