NVG-291 enters registrational RESTORE study in chronic tetraplegia; thesis resolves on whether Phase 2 neural recovery signals replicate at scale

NervGen is a clinical-stage company developing a targeted neural regeneration therapy for chronic spinal cord injury with tetraplegia that is not yet approved.

NVG-291, a PTPσ inhibitor targeting neural regeneration, is entering the RESTORE registrational study in chronic tetraplegia patients with established spinal cord injury. The thesis turns on whether RESTORE replicates the statistically significant biomechanical gait improvements seen in CONNECT SCI at registrational scale and satisfies FDA's endpoint requirements. The primary risks are competitive pressure from rehabilitation-focused approaches and the absence of any approved disease-modifying SCI therapy as a regulatory comparator, which cuts both ways on approvability standards.