NervGen Pharma Corp. Common stock

NervGen Announces First Participant Dosed in RESTORE, a Phase 3 Registrational Study Evaluating NVG-291 in Chronic Spinal Cord Injury

NervGen dosed the first participant in RESTORE, a Phase 3 registrational study of NVG-291 in chronic cervical motor-incomplete spinal cord injury. The trial plans to enroll roughly 150 participants across the US and Canada, with enrollment completion targeted for the second half of 2027 and topline data expected in the first half of 2028. The design follows FDA alignment at End-of-Phase 2 and builds on positive Phase 1b/2a CONNECT SCI results; NVG-291 holds FDA Fast Track and EMA Orphan Drug designations.

•20d ago

NervGen Reports Second Quarter 2026 Financial Results and Provides Business Updates

NervGen reported a Q2 net loss of C$0.32 per share, with R&D expenses rising to C$7.9 million due to Phase 3 RESTORE study start-up costs. The company ended the quarter with C$86.8 million in cash, which is expected to fund operations through the anticipated topline data readout from RESTORE in the first half of 2028. Site activation and screening for the Phase 3 RESTORE study are expected to begin in September 2026, alongside leadership appointments including Keith Vendola as CFO.

•2mo ago

NervGen Announces Positive Independent, Blinded Biomechanical Gait Analyses Demonstrating Genuine Neural Recovery with NVG-291 in Phase 1b/2a CONNECT SCI Study

NervGen announced positive independent, blinded biomechanical gait analyses for its lead asset NVG-291 in the Phase 1b/2a CONNECT SCI study. The Global Statistical Test showed a significant treatment effect favoring NVG-291 (p=0.0197), with 100% of treated subjects classified as responders versus 10% of placebo subjects (p=0.0001). These findings provide objective evidence of genuine neural recovery rather than compensation, reinforcing the rationale for the upcoming Phase 3 RESTORE registrational study, which is on track to initiate in mid-2026.

•5mo ago

NervGen Reports First Quarter 2026 Financial Results and Provides Business Updates

NervGen reported Q1 2026 financial results with a net loss of $1.7 million, significantly improved from $3.9 million in the prior year, aided by a $5.7 million non-cash gain on warrant derivatives. The company highlighted successful FDA alignment on the RESTORE registrational study for NVG-291 in chronic tetraplegia, with site activation underway and initiation targeted for mid-2026. Independent biomechanical gait analyses from the CONNECT SCI study are ongoing, with results expected in 2Q 2026 to differentiate neural recovery from compensatory movement. NervGen also announced three senior leadership appointments, including a new CFO, CRAO, and SVP of Patient Advocacy, to support late-stage clinical development and its Nasdaq listing.

•5mo ago

NervGen Pharma Strengthens Leadership Team with Appointment of Keith Vendola as Chief Financial Officer

NervGen Pharma appointed Keith Vendola, MD, MBA, as Chief Financial Officer, effective immediately, adding over two decades of experience in biopharma finance and strategy. The company is accelerating clinical development of NVG-291 toward the RESTORE registrational study in chronic tetraplegia, where Dr. Vendola's capital markets expertise will be instrumental. NVG-291 is a first-in-class neuroreparative peptide that received Fast Track designation from the FDA and Orphan Drug designation from the EMA.

•6mo ago