r/NervGen_NerveRepair

I have taken this from Google.

2017: Scientific Inception

• Founding Inspiration: After a spinal cord injury left the daughter-in-law of co-founder Dr. Harold Punnett paralyzed, he sought solutions and connected with pioneering neuroscientist Dr. Jerry Silver. [1]
• Company Creation: In 2017, NervGen Pharma was established to license and commercialize Dr. Silver's breakthrough work on Chondroitin Sulfate Proteoglycans (CSPGs) and receptor type protein tyrosine phosphatase sigma (PTPσ). [1, 2]

🐀 2018–2020: Preclinical Proof of Concept

• Animal Studies: Preclinical tests utilizing NVG-291-R (the rodent analog) demonstrated remarkable success in repairing nervous system damage, promoting axonal regeneration, and restoring functional mobility in animal models of stroke, MS, and spinal cord injury.
• IP Expansion: NervGen solidified exclusive worldwide patent rights for the core therapeutic peptide. [1]

🩺 2021–2022: Phase 1 Safety Trials

• Healthy Volunteer Study: NervGen initiated and completed its Phase 1 clinical trial assessing the safety, tolerability, and pharmacokinetics of NVG-291 in healthy subjects.
• Safety Established: The drug completed Phase 1 successfully, showing no serious adverse events and establishing safe dosing thresholds required to move into patient populations.

🏥 2023–2025: Phase 1b/2a "CONNECT SCI" Trial

• Trial Launch (Mid-2023): NervGen launched the CONNECT SCI Study (NCT05965700) to test safety and efficacy in patients with cervical spinal cord injuries, split into subacute and chronic cohorts.
• FDA Fast Track (October 2023): The FDA granted Fast Track Designation to accelerate development.
• Blinded Efficacy Signals (Late 2025): Topline data from the chronic cohort (patients 1–10 years post-injury) revealed highly promising, durable improvements in hand function, bladder control, and mobility. [1, 2, 4]

🚀 2026: Nasdaq Listing and Phase 3 Transition

• January 2026: NervGen successfully listed on the Nasdaq exchange under the ticker NGEN.
• April 2026: Final data from the chronic cohort revealed up to an 825% improvement in hand function (via GRASSP scale) compared to placebo.
• FDA Alignment (April 2026): NervGen held a successful End-of-Phase 2 meeting with the FDA, securing alignment on the parameters of RESTORE, a Phase 3 registrational trial. Subacute enrollment was concluded to focus resources heavily on Phase 3.
• May 2026: Independent, blinded biomechanical gait analyses confirmed the drug induces genuine neural recovery rather than compensatory movements.
• Current Status (Mid-2026): Phase 3 RESTORE site activation is actively underway, with patient recruitment preparing to launch for chronic tetraplegia across the US and Canada. [1, 2, 3, 4, 5]