NervGen Pharma Announces Successful End-of-Phase 2 Meeting and FDA Alignment on RESTORE, a Phase 3 Registrational Study of NVG-291 for Chronic Tetraplegia
Rhea-AI Summary
NervGen (NASDAQ:NGEN) completed a successful End-of-Phase 2 meeting with the FDA and obtained alignment on RESTORE, a randomized, double-blind, placebo-controlled Phase 3 registrational study of NVG-291 in chronic tetraplegia. RESTORE targets ~150 subjects across up to 60 US and Canadian sites, with daily subcutaneous dosing for 12 weeks and a 4-week observational period. The primary endpoint is change in GRASSP Quantitative Prehension at Week 12. RESTORE initiation is on-track for mid-2026 and includes an optional 12-week open-label extension for placebo subjects. Phase 1b/2a CONNECT SCI data showed a +3.7 vs +0.4 mean GRASSP QtP improvement at Week 12 (+3.3 treatment difference) and favorable safety with no treatment-related serious adverse events.
Positive
- FDA alignment on Phase 3 registrational design
- RESTORE planned for ~150 randomized subjects
- Primary endpoint: GRASSP QtP at Week 12
- CONNECT SCI treatment difference: +3.3 points at Week 12
- No treatment-related serious adverse events in CONNECT SCI
Negative
- CONNECT SCI had only 8 NVG-291-treated subjects
- CONNECT SCI placebo arm included 9 subjects
- RESTORE enrollment limited to adults 18–75, ASIA C/D, 1–10 years post-injury
News Market Reaction – NGEN
In the Apr 7 session, NGEN declined 9.57%, reflecting a notable negative market reaction. Argus tracked a trough of -16.6% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility. Trading volume was very high at 3.9x the daily average, suggesting heavy selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Mar 31 | Earnings and update | Neutral | +1.1% | Full-year 2025 results plus confirmation of EOP2 completion and Phase 3 timing. |
| Mar 12 | TSXV delisting move | Positive | -7.0% | Voluntary TSXV delisting and ATM termination to streamline listing and costs. |
| Mar 04 | Leadership appointments | Positive | +8.1% | Hiring senior regulatory and patient advocacy leaders to support NVG-291. |
| Feb 18 | Investor conferences | Neutral | +1.2% | Management participation in multiple investor conferences and 1x1 meetings. |
| Feb 12 | CFO retirement | Negative | +2.4% | Announcement of CFO retirement and transition planning with search firm. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news has more often aligned with price moves, though regulatory/structural actions have sometimes produced divergent reactions.
Over the last few months, NervGen has steadily advanced NVG-291 toward late-stage development, including executive hires to support regulatory strategy and investor outreach via conferences. Corporate actions such as a voluntary TSXV delisting and termination of an ATM program preceded today’s confirmation of FDA alignment on the RESTORE Phase 3 design. Earlier, a full-year 2025 update noted completion of the End-of-Phase 2 meeting and a mid-2026 Phase 3 start goal, which today’s announcement operationalizes with detailed endpoints and study parameters.
Key Terms
end-of-phase 2 regulatory
phase 3 regulatory
registrational study regulatory
randomized, double-blind, placebo-controlled technical
graspp quantitative prehension medical
asia impairment scale medical
spinal cord independence measure, version-iii (scim-iii) medical
modified ashworth scale medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
- Alignment with the FDA across proposed study parameters of RESTORE, a 16-week registrational study evaluating NVG-291 in chronic tetraplegia.
- Primary endpoint will be the change from baseline in GRASSP Quantitative Prehension at Week 12, a validated functional endpoint designed to capture improvement in fine-motor hand use, the highest priority domain in tetraplegia.
- Key secondary endpoints include Patient and Clinician Global Impression of Change (PGIC/CGIC), and blinded qualitative interviews designed to contextualize the clinical meaningfulness of NVG-291.
- RESTORE initiation remains on-track for mid-2026, with study initiation activities underway.
VANCOUVER, British Columbia, April 07, 2026 (GLOBE NEWSWIRE) -- NervGen Pharma Corp. (“NervGen” or the “Company") (NASDAQ: NGEN), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions, today announced the completion of a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and alignment on RESTORE, the Company’s Phase 3 registrational study designed to evaluate NVG-291 for the treatment of chronic tetraplegia.
“We are grateful for the continued and collaborative partnership with the FDA,” said Adam Rogers, MD, President and Chief Executive Officer of NervGen. “RESTORE's design, anchored by the strength and totality of the CONNECT SCI data, was shaped in close collaboration with the FDA, the SCI community, key opinion leaders, and advocates, to ensure the clinical data and outcomes generated reflect what matters most to the individuals it's designed to serve. We are working tirelessly and advancing with urgency to continue developing a potentially life-changing therapy for individuals with chronic tetraplegia.”
“I have spent over 30 years working to advance treatments for SCI, and the progress we are witnessing with NVG-291 represents the most compelling clinical evidence for a pharmacologic treatment to date in chronic tetraplegia," said Armin Curt, MD, Clinical Director of the Accelerated Translational Program at Wings for Life, a global nonprofit research foundation with the mission to find a cure for SCI. "Wings for Life supported CONNECT SCI because we believed in NVG-291, and the data validated that belief. RESTORE's registrational trial design, including the use of GRASSP Quantitative Prehension as a functional primary endpoint uniquely designed to capture change in the highest priority domain in tetraplegia, represents what we believe will be the future for clinical trial design in SCI. Paired with secondary measures and blinded qualitative interviews that convey both the participant and clinician perspective on independence and quality of life, this design reflects the rigor and depth the SCI community deserves. This is a tangible step toward making the first pharmacologic treatment for chronic tetraplegia a reality.”
Overview of the RESTORE Phase 3 Registrational Study Design
- Study Design: Randomized, double-blind, placebo-controlled; approximately 150 subjects.
- Population Characteristics: Adults aged 18-75 with chronic tetraplegia due to traumatic SCI (≥C7; ASIA Impairment Scale C or D), 1-10 years post-injury.
- Study Sites: Up to 60 sites across the United States and Canada.
- Dosing Regimen: Daily subcutaneous injections of NVG-291 for 12 weeks, followed by a 4-week observational period.
- Primary Endpoint: Change from baseline to Week 12 in GRASSP Quantitative Prehension (QtP), a validated measure of functional hand use.
- Key Secondary Endpoints: PGIC, CGIC, Spinal Cord Independence Measure, Version-III (SCIM-III), and lower extremity spasticity, as measured by the Modified Ashworth Scale.
- Qualitative Assessments: Blinded qualitative interviews will be conducted when exiting the 16-week study period to contextualize the clinical meaningfulness and real-world impact of NVG-291.
- Open-Label Extension (OLE): An optional 12-week OLE will follow the main study, providing access to NVG-291 for all placebo-randomized subjects.
The RESTORE registrational study remains on-track for initiation in mid-2026, with study initiation activities underway.
Phase 1b/2a CONNECT SCI Chronic Tetraplegia Data Supports the RESTORE Phase 3 Registrational Study Design
Data from the randomized, placebo-controlled Phase 1b/2a CONNECT SCI study in chronic tetraplegia supports the RESTORE registrational study design, including endpoint selection, timing of assessments, and dosing regimen.
- Primary Endpoint Selection (GRASSP QtP): A mean improvement of +3.7 points at Week 12 in NVG-291-treated subjects versus +0.4 points for placebo-treated subjects (+3.3-point treatment difference), exceeding the 2.0-point minimally important difference.
- Sustained Treatment Effect at Week 16: Continued improvement in GRASSP QtP to +4.4 points for NVG-291-treated subjects versus +1.2 points for placebo-treated subjects, demonstrating a sustained treatment effect at Week 16, four weeks after treatment cessation.
- Clinical Meaningfulness (PGIC):
75% (6/8) of NVG-291-treated subjects reported being “much” or “very much” improved (≥6/7 PGIC score) versus33% (3/9) of placebo-treated subjects, reinforcing the relevance of observed functional gains. - Real-World Impact: Blinded qualitative interviews conducted up to 364 days post-study contextualized systemic improvements, including
67% (6/9) of NVG-291-treated subjects reporting improved bladder control and56% (5/9) reporting reduced muscle spasticity. - Dosing Regimen and Safety: Favorable safety and tolerability across 12 weeks of daily subcutaneous dosing of NVG-291, with no treatment-related serious adverse events or treatment discontinuations.
Phase 1b/2a CONNECT SCI Subacute Tetraplegia Update
Following a successful EOP2 meeting and FDA alignment across the proposed study parameters of RESTORE, NervGen has elected to conclude enrollment in the Phase 1b/2a CONNECT SCI study in subacute tetraplegia and unblind available data.
FDA alignment on the RESTORE registrational study design emphasizes clinical endpoints that capture how individuals with chronic tetraplegia function, feel, and succeed in everyday life. The Company intends to apply this regulatory alignment and endpoint framework to inform a future registrational-quality study in subacute tetraplegia.
About NervGen Pharma
NervGen Pharma Corp. (NASDAQ: NGEN) is a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other neurotraumatic and neurologic conditions. The Company’s mission is to transform the lives of individuals living with SCI by enabling the nervous system to repair itself. NervGen’s lead therapeutic candidate, NVG-291, is a subcutaneously administered, neuroreparative peptide designed to target the inhibitory CSPG-PTPσ pathway. NVG-291 is the first pharmacologic candidate to improve function, independence, and quality of life in chronic tetraplegia, as demonstrated in the Phase 1b/2a CONNECT SCI study. NVG-291 has received Fast Track designation from the FDA and Orphan Drug designation from the European Medicines Agency for the treatment of SCI. Through NVG-291 and the Company’s next-generation candidate, NVG-300, NervGen is pursuing a pharmacologic approach to transform the treatment paradigm for neurotraumatic and neurologic conditions with significant unmet medical need. For more information, visit www.nervgen.com and follow NervGen on X and LinkedIn.
Contacts
Huitt Tracey, Investors
htracey@nervgen.com
604.537.2094
David Schull or Ignacio Guerrero-Ros, Ph.D., Media
Russo Partners
David.Schull@russopartnersllc.com
Ignacio.Guerrero-Ros@russopartnersllc.com
858.717.2310
Cautionary Note Regarding Forward Looking Statements
This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable securities laws (collectively, "forward-looking statements"). Such forward-looking statements herein include but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the Company's potentially best-in-class candidate, NVG-291; the potential broad therapeutic applications of NVG-291; the regulatory pathways available to the Company for NVG-291; the design, objectives, planned clinical endpoints, timing, expected rate of enrollment, and results of the RESTORE registrational clinical trial of NVG-291 in chronic tetraplegia; NVG-291 as potentially the first approved pharmacologic treatment for chronic tetraplegia; the anticipated timing of RESTORE study start; the Company's election to conclude enrollment in the subacute tetraplegia cohort of the Phase 1b/2a CONNECT SCI study and the planned unblinding and analysis of available subacute data; the Company's intent to inform a future registrational-quality study in subacute tetraplegia; the potential of NVG-291 to address the unmet medical need for patients with SCI; the anticipated timing of additional data and analyses relating to NVG-291 for SCI; the procurement of drug supply for future NVG-291 clinical trials; the sufficiency of the Company's cash and investments to fund its operations and clinical development plans; and the creation of neuroreparative therapeutics to enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: its ability to obtain future funding on favorable terms, if at all; the accuracy of its financial projections; obtaining positive results in its clinical trials; its ability to obtain necessary regulatory approvals; its ability to arrange for the manufacturing of its product candidates and technologies; and general business, market and economic conditions. Many factors could cause the Company's actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the Company's most recently filed Annual Information Form, which is available under the Company’s profile on SEDAR+ at www.sedarplus.ca (which are also incorporated in the recently filed form 40-F available on the website of the U.S. Securities and Exchange Commission (the “SEC") at www.sec.gov), including the management’s discussion & analysis for the year-ended December 31, 2025. All clinical development plans are subject to additional funding. Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and the Company has no intention and undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement.
