NV-387

June 29, 2026: NanoViricides, Inc. (NYSE: NNVC) announced the FDA Office of Orphan Products Development granted its broad-spectrum antiviral NV-387 a Rare Pediatric Disease Drug (RPDD) designation for treatment of measles. The designation makes NV-387 eligible for a Priority Review Voucher (PRV) if the company later submits and wins approval of a marketing application (NDA) for NV-387 in measles and all conditions are met; the PRV could be used for another application or sold (the release cites a recent PRV sale of $195 million).

The company also stated FDA has now granted both Orphan Drug Designation (ODD) and RPDD for NV-387 in measles, with ODD incentives including clinical trial tax credits, certain user-fee exemptions, and potential seven-year market exclusivity after approval.

NanoViricides said it is currently focused on advancing NV-387 into Phase II human clinical trials, but cannot project an exact date for any IND filing due to reliance on external collaborators.