NervGen NVG-291 RESTORE Registrational Phase 3 in Chronic Tetraplegia Targets Mid-2026 Initiation After FDA End-of-Phase 2 Alignment; Blinded Biomechanical Gait Analysis Expected Q2 2026 From CONNECT SCI Chronic Cohort
NervGen Pharma (Nasdaq: NGEN) confirmed in its Q1 2026 results (early May) that the RESTORE registrational Phase 3 study of NVG-291 in chronic tetraplegia (cervical chronic spinal cord injury, SCI) remains on track for mid-2026 initiation after a successful FDA End-of-Phase 2 meeting. NVG-291 is a subcutaneous peptide mimetic of the intracellular signaling domain of intracellular sigma peptide (ISP), designed to plasticize neural pathways and enable functional recovery in chronic SCI — a first-in-class mechanism where no pharmacological intervention has shown durable motor recovery before. The expanded chronic CONNECT SCI Phase 1b/2a data (n=10 active vs n=10 placebo) showed a three-fold increase in motor connectivity to the first dorsal interosseus hand muscle. Biomechanical gait analysis from an independent movement-intelligence firm is expected Q2 2026 to disentangle genuine neural recovery from compensatory mechanics. Cash was $16.6M as of March 31, 2026 (listed Nasdaq Jan 8, 2026).