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An announcement from NervGen Pharma ( (NGEN) ) is now available.
NervGen Pharma has secured alignment with the U.S. Food and Drug Administration on RESTORE, a Phase 3 registrational trial of its lead drug candidate NVG-291 in individuals with chronic tetraplegia, following a successful End-of-Phase 2 meeting. The 16-week, randomized, double-blind, placebo-controlled study will enroll about 150 adults with traumatic spinal cord injury at up to 60 sites in the U.S. and Canada, with initiation targeted for mid-2026.
The trial’s primary endpoint will measure change at Week 12 in GRASSP Quantitative Prehension, a validated functional assessment of fine-motor hand use, reflecting the highest priority for tetraplegic patients, while key secondary endpoints will capture broader functional independence and global impressions of change. Backed by encouraging Phase 1b/2a CONNECT SCI data that showed clinically meaningful gains in hand function, the RESTORE design is being hailed by experts as a potential new standard for spinal cord injury trials and a pivotal step toward the first pharmacologic treatment for chronic tetraplegia, with an open-label extension offering further access to NVG-291 for participants.
The most recent analyst rating on (NGEN) stock is a Buy with a $5.50 price target. To see the full list of analyst forecasts on NervGen Pharma stock, see the NGEN Stock Forecast page.
More about NervGen Pharma
NervGen Pharma is a clinical-stage biopharmaceutical company focused on developing first-in-class neuroreparative therapeutics for spinal cord injury and other neurotraumatic and neurologic conditions. Its lead candidate, NVG-291, targets chronic spinal cord injury, with a particular emphasis on improving function in individuals living with chronic tetraplegia in the U.S. and Canada.
Average Trading Volume: 152,378
Technical Sentiment Signal: Buy
Current Market Cap: $294.3M
Learn more about NGEN stock on TipRanks’ Stock Analysis page.