NervGen Kicks Off Pivotal Phase 3 Test of NVG-291 in Chronic Spinal Cord Injury

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1. Ownership and Share Structure Information

The information listed above was updated on the date this article was published and was compiled from information from the company and various other data providers.

• NervGen dosed the first participant on Oct. 12 in RESTORE, its Phase 3 registrational study of NVG-291 in chronic cervical spinal cord injury.
• The roughly 150-patient study uses hand function, measured by GRASSP Quantitative Prehension, as its primary endpoint. Enrollment is expected to finish in the second half of 2027, with topline data in the first half of 2028.
• NervGen aligned with the FDA on the trial design, and NVG-291 holds FDA Fast Track and EMA Orphan Drug designations for SCI.
• In the Phase 1b/2a CONNECT SCI study, NVG-291 significantly improved a measure of hand muscle nerve signaling versus placebo, while the GRASSP hand function score trended positive without reaching statistical significance.
• All three analysts who have rated NervGen in the past three months rate it a Buy, according to TipRanks.
• Newsletter writer Chen Lin expects the company to need more funding before 2028.
• About 305,000 people in the United States live with SCI, and the global SCI therapeutics market is projected to reach US$10.7 billion by 2031.

NervGen Pharma Corp. (NGEN:NASDAQ) has dosed the first participant in RESTORE, its Phase 3 registrational study of NVG-291 in people living with chronic cervical motor-incomplete spinal cord injury (SCI), the company announced in an Oct. 12 release.

"Dosing the first participant in RESTORE marks a critical milestone for NervGen," said CEO Adam Rogers, MD.

The multicenter, randomized, double-blind, placebo-controlled study is expected to enroll about 150 participants across the United States and Canada. Eligible participants are one to ten years past a traumatic SCI, with a motor level of C7 or higher and an ASIA Impairment Scale grade of C or D. They will be randomized 1:1 to receive once-daily subcutaneous injections of NVG-291 or placebo for 12 weeks, followed by a four-week observation period, with an optional 12-week open-label extension.

The primary endpoint measures hand function using GRASSP Quantitative Prehension, a priority for people with cervical SCI. Secondary endpoints, including blinded participant interviews, assess functional independence and quality of life. NervGen expects to complete enrollment in the second half of 2027 and report topline data in the first half of 2028.

NervGen reached alignment with the FDA on RESTORE's design following an End-of-Phase 2 meeting. NVG-291 holds FDA Fast Track designation and EMA Orphan Drug designation for SCI.

The design builds on the placebo-controlled Phase 1b/2a CONNECT SCI study. In June 2025, NervGen reported topline data from the study's chronic cohort showing a statistically significant increase in hand muscle motor evoked potentials, a measure of nerve signaling, on NVG-291 versus placebo. Its GRASSP hand function score trended positively but did not reach statistical significance. NVG-291 was generally safe and well-tolerated.

To fund development, NervGen priced a US$60 million public offering in May at US$2.50 per share, with each share accompanied by a warrant exercisable at US$3.68.

Analysts covering NervGen remain positive. TipRanks gives the stock a Strong Buy consensus based on two analysts, with an average price target of US$12.50. 

H.C. Wainwright's Ram Selvaraju reiterated a Buy on July 14 while trimming his target to US$15 from US$18, and Leerink Partners' Marc Goodman initiated coverage on July 13 with an Outperform rating and a US$10 target. 

TD Cowen's Joseph Thome also reiterated his Buy rating on Aug. 13.

Chen Lin, who writes What Is Chen Buying? What Is Chen Selling?, took a more cautious view in an October 12 note. Noting that NervGen expects RESTORE results in the first half of 2028, Lin wrote, "With this plan, they will need to add more money, possibly through ATM or other means, before the data."

Lin called NervGen "one of my biggest losers this year" and said he was "shocked they raised money at such bad terms." Unless the company pursues accelerated approval, he wrote, NervGen is unlikely to have "any significant catalysts until H1 2028."

Lin also pointed to broader pressure on the sector. "Biotechs are getting killed by high interest rates recently," he wrote. "I am hearing some funds are doing forced liquidation now."

Spinal cord injuries are among the most disabling conditions in neurology. About 20.6 million people worldwide were living with SCI in 2019, with roughly 900,000 new cases that year, according to the Global Burden of Disease Study. In the United States, about 18,000 new injuries occur each year, the National Spinal Cord Injury Statistical Center estimates.

NervGen's target group is a large share of that population. Incomplete tetraplegia, the category RESTORE is enrolling, is the most common type of SCI in the United States, accounting for 47.4% of cases tracked by the center.

The costs are steep. Lifetime costs for a person injured at age 25 range from about US$2 million for those who keep some motor function to more than US$6 million for high tetraplegia. The global SCI therapeutics market is projected to reach US$10.7 billion by 2031, according to Coherent Market Insights. 

Yet there are "no approved pharmacologic treatments for SCI," Randall Kaye, MD, NervGen's chief medical advisor, said in a November 2025 release.

NervGen Pharma Corp. has a market cap of US$168.27 million, with 107.52 million shares outstanding. The company's 52-week range is US$1.55-US$6.30.

Institutions own 11.24% of shares, while management and insiders own 15.72%. The rest is retail.

What is the design of the RESTORE Phase 3 study?

RESTORE is a multicenter, randomized, double-blind, placebo-controlled trial enrolling about 150 adults with chronic cervical motor-incomplete SCI. Participants receive daily injections of NVG-291 or placebo for 12 weeks, and the primary endpoint is hand function measured by GRASSP Quantitative Prehension.

When are topline results expected?

NervGen expects to complete enrollment in the second half of 2027 and report topline data in the first half of 2028.

What did earlier clinical data show?

In the Phase 1b/2a CONNECT SCI study's chronic cohort, NVG-291 produced a statistically significant increase in hand muscle motor evoked potentials versus placebo. The GRASSP hand function score trended positive but did not reach statistical significance, and the drug was generally safe and well-tolerated.

How is NervGen funding the trial?

NervGen priced a US$60 million public offering in May at US$2.50 per share, with warrants exercisable at US$3.68. Newsletter writer Chen Lin expects the company will need to raise more money before the 2028 data.