NervGen secures FDA nod for mid-2026 Phase 3 tetraplegia trial after 825% hand use gain
NervGen completed its End-of-Phase 2 FDA meeting and expects a regulatory update in early Q2 2026 while remaining on track to initiate a mid-2026 Phase 3 study of NVG-291 after reporting an 825% hand use improvement in Phase 1b/2a. As of December 31, 2025, it held $22.1 million in cash.
1. Phase 3 Development Plans
NervGen completed its End-of-Phase 2 meeting with the FDA in Q1 2026 and expects to provide a regulatory update in early Q2. The company remains on track to initiate a pivotal Phase 3 study of NVG-291 in chronic tetraplegia by mid-2026, focusing on systemic neural recovery endpoints.
2. Clinical Trial Results and Upcoming Data
In June 2025, the Phase 1b/2a CONNECT SCI study in chronic tetraplegia achieved an 825% improvement in functional hand use versus placebo (p=0.0155) with durable gains through Week 16 and up to 364 days post-treatment. Independent, blinded biomechanical gait analyses are ongoing, with results slated for presentation in Q2 2026 to distinguish genuine neural repair from compensatory movements.
3. Financial Position and Runway
As of December 31, 2025, NervGen held $22.1 million in cash, up from $17.3 million a year earlier following private placement proceeds and warrant exercises. Full-year 2025 R&D expenses were $13.9 million, G&A expenses $11.2 million, and net loss totaled $44.1 million ($0.61 per share), reflecting continued investment in NVG-291 development.
4. Leadership and Corporate Updates
The company strengthened its leadership team by appointing Adam Rogers as Chairman, President and CEO and adding senior advisors Shamim Ruff and Christine McSherry in early 2026. NervGen successfully listed on Nasdaq and is conducting a search to appoint a successor CFO after Bill Adams transitioned to an advisory role.