NervGen’s NVG-291 receives FDA breakthrough therapy designation for chronic spinal cord injury
NGEN•NervGen said the FDA granted NVG-291 Breakthrough Therapy designation for chronic traumatic cervical motor-incomplete spinal cord injury. Its Phase 3 RESTORE study is enrolling participants in the United States and Canada.
1. FDA designation
NervGen received FDA Breakthrough Therapy designation for NVG-291 to treat chronic traumatic cervical motor-incomplete spinal cord injury. The designation could accelerate development and regulatory review, including eligibility for Priority Review.
2. Study progress
Previously reported Phase 1b/2a CONNECT SCI results showed improved functional hand use and patient-reported gains in everyday function versus placebo. NVG-291 was generally well tolerated, with no serious adverse events or treatment discontinuations. The Phase 3 RESTORE registrational study is enrolling participants, with site activation continuing in the United States and Canada.
