Nutriband CEO still sees Aversa Fentanyl regulatory approval within 2025

Nutriband (NTRB) CEO Gareth Sheridan issued a letter to shareholder in which he maintains the 2025 NDA submission timeline for lead product Aversa Fentanyl. With no need for Phase 2 or Phase 3 clinical trials, Nutriband expects an expedited review process, potentially positioning Nutriband to achieve regulatory approval before the end of 2025. If approved, Aversa Fentanyl is projected to achieve peak annual U.S. sales of $80M-$200M. With potential regulatory approval in 2025, Nutriband is preparing for the commercialization of Aversa Fentanyl by scaling up its partnership with Kindeva Drug Delivery. Sheridan stated that the company has “strengthened our balance sheet with $8.4M in capital from a successful non brokered private placement, leaving us well-positioned to fund the final development stages of Aversa Fentanyl”.