Research Capital analyst Andre Uddin maintained his “Speculative Buy” rating and US$ 5.50 target on NervGen Pharma (NervGen Pharma Stock Quote, Chart, News, Analysts, Financials NASDAQ:NGEN) after the company said it had completed its end-of-Phase 2 meeting with the U.S. Food and Drug Administration, clearing the way for the Phase 3 RESTORE trial in chronic tetraplegia.
Uddin said the pivotal study is expected to enroll about 150 patients at roughly 60 sites across the United States and Canada, with startup activity already underway and trial initiation still expected around mid-2026. He said enrollment could be completed in the second half of 2027, with topline data in the first half of 2028 and a potential NDA filing in the second half of 2028.
“If the Phase 3 results are positive, we believe the company would move significantly closer to delivering the first effective therapy for spinal cord injury,” Uddin said in an April 7 note. He added that his outlook remains positive given NVG-291’s earlier CONNECT data and its novel mechanism of action.
The primary endpoint in RESTORE will measure change in hand function after 12 weeks using the GRASSP Quantitative Prehension test, with secondary measures including patient- and clinician-reported improvement, independence in daily activities and lower-extremity spasticity. Uddin said the design was supported by results from the earlier Phase 1b/2a CONNECT study, where NVG-291-treated patients showed stronger hand-function gains than placebo patients and also reported more meaningful real-world improvement.
NervGen also said enrollment has been completed in the subacute arm of the Phase 1b/2a CONNECT study, while additional data from chronic spinal cord injury patients is expected in the second quarter of 2026.
“To date, there is no effective therapy for spinal cord injury,” Uddin said. “Data suggest that NervGen’s NVG-291 has the potential to be a novel therapy for this underserved blockbuster market.”
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