Feb. 3 at 10:27 PM
$NGEN Facts:
On 10:23/23, regarding being designated with FDA Fast Track status, Nervgen stated: “Fast Track also provides eligibility for both Priority Review, which can shorten the New Drug Development (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster approval based on a surrogate or intermediate clinical endpoint.”
On 11/24/25, Nervgen stated: “Today, we announced that the Company completed an FDA Type C meeting in September to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that multiple regulatory pathways are available to support approval, given the significant unmet medical need among individuals living with SCI and the lack of any approved pharmacologic treatments. The Company anticipates an End-of-Phase 2 meeting in early 2026 to further align with the FDA on the development and registration pathway for NVG-291.”
