NervGen Advances Chronic Tetraplegia Trial After FDA Alignment

Event summary

  • NervGen completed an FDA End-of-Phase 2 meeting, aligning on RESTORE study parameters for NVG-291 in chronic tetraplegia, with site activation underway and study initiation on track for mid-2026.
  • Independent, blinded biomechanical gait analyses from the CONNECT SCI study are ongoing, with results anticipated in 2Q 2026.
  • NervGen listed on Nasdaq under the symbol 'NGEN' on January 8, 2026, and voluntarily delisted from the TSX Venture Exchange.
  • Strengthened leadership team with three senior appointments to support late-stage clinical development and Nasdaq listing.
  • Reported cash and investments of $16.6 million as of March 31, 2026, with R&D expenses of $4.9 million for Q1 2026.

The big picture

NervGen's strategic shift towards late-stage clinical development and Nasdaq listing reflects its ambition to become a key player in neuroreparative therapeutics. The company's focus on chronic tetraplegia, a condition with significant unmet medical need, positions it to potentially revolutionize treatment paradigms in neurotraumatic and neurologic conditions. The strengthened leadership team and FDA alignment on the RESTORE study underscore NervGen's commitment to advancing NVG-291 towards potential approval.

What we're watching

Regulatory Alignment
How the FDA's alignment on RESTORE study parameters will impact the timeline and success of NVG-291's registrational trial.
Clinical Data
Whether the independent biomechanical gait analyses can objectively differentiate genuine neural recovery from compensatory movement.
Pipeline Expansion
The pace at which NervGen can prioritize and initiate clinical development in additional indications for NVG-291.