NervGen Pharmaceutics (NASDAQ:NGEN) reported its full-year 2025 financial and operational results on Tuesday, March 31, 2026, marking a definitive shift toward pivotal-stage clinical development.
The company, which focuses on nervous system repair, announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding its lead candidate, NVG-291.
Following the regulatory consultation, NervGen remains on track to initiate a landmark Phase 3 clinical study in patients with chronic tetraplegia in mid-2026.
This pivotal trial is designed to evaluate the efficacy of NVG-291 in restoring motor function and sensory perception in individuals living with long-term spinal cord injuries.
To further support the clinical narrative, the company expects to present independent biomechanical gait analyses from its earlier studies during the second quarter of 2026.
Financially, NervGen ended the 2025 fiscal year with $22.1 million in cash and investments.
The company reported a net loss of $44.1 million for the year, compared to a loss of $24.3 million in 2024.
The increased spending reflects the scaling of its research and development organization, where R&D expenses rose to $13.9 million, alongside general and administrative (G&A) costs of $11.2 million.
The 2025 fiscal year was also characterized by significant institutional milestones, including the company’s successful listing on the Nasdaq Capital Market and several key additions to its executive leadership team.