NervGen Says FDA Grants NVG-291 Breakthrough Therapy Designation For Treatment Of Chronic Traumatic Cervical Motor-Incomplete SCI

• Breakthrough Therapy designation granted based on FDA’s review of safety and efficacy data from the chronic cohort of the Phase 1b/2a CONNECT SCI study
• Phase 3 RESTORE registrational study enrolling participants, with site activation continuing in the United States and Canada

MIAMI, Nov. 12, 2026 (GLOBE NEWSWIRE) -- NervGen (NASDAQ:NGEN), a late-stage clinical biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today announced that the U.S. Food and Drug Administration (FDA) has granted NVG-291 Breakthrough Therapy designation for the treatment of chronic traumatic cervical motor-incomplete SCI. NVG-291 is being developed as potentially the first therapy to promote nerve regeneration in individuals living with chronic SCI.

Preliminary clinical evidence from the Phase 1b/2a CONNECT SCI study demonstrated substantial improvements on a clinically significant endpoint assessing functional hand use in individuals with chronic traumatic cervical motor-incomplete SCI. These findings were supported by Patient Global Impression of Change (PGIC) and blinded qualitative interviews documenting participant-reported gains in everyday function and independence compared to placebo. NVG-291 was generally well tolerated, with no serious adverse events or treatment discontinuations.