Healthcare

US FDA Has Granted A "Rare Pediatric Disease Drug" Designation for NV-387 As A Treatment for Measles - Enables Priority Review Voucher

SHELTON, CT / ACCESS Newswire / June 29, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic ...

articleNanoviricides, Inc.June 29, 202610 min read/news/us-fda-has-granted-a-rare-pediatric-disease-drug-designation-for-nv-387-as-a-treatment-for-measles-enables-priority-review-voucher
US FDA Has Granted A "Rare Pediatric Disease Drug" Designation for NV-387 As A Treatment for Measles - Enables Priority Review Voucher

About this update from Nanoviricides, Inc.

SHELTON, CT / ACCESS Newswire / June 29, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted a "Rare Pediatric Disease Drug" (RPDD) Designation by the US FDA Office of Orphan Products Development (OOPD). This RPDD designation enables that a Priority Review Voucher (PRV) can be issued to the Company upon a successful Marketing Application (i.e. New Drug Application) for the use of NV-387 as a treatment for Measles, provided all of the required conditions are met. The Company can use the PRV, if granted, to reduce review times on another of its drug applications. Importantly, a PRV can be sold to another Pharma Company for accelerating their drug program as well, which provides a high value to the purchaser. Recently, a PRV has been sold for $195 Million1. Sale of a PRV can bring cash to the Company even prior to revenues from commercialization of a drug product. "The Rare Pediatric Disease Drug Designation and associated Priority Review Voucher that can be issued make a strong business case for development of NV-387 as a drug for the treatment of Measles," said Anil R. Diwan, PhD., adding, "NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved." FDA has now granted both ODD and RPDD for NV-387 as a Treatment of Measles. In addition to the PRV eligibility provided by the RPDD for NV-387 as a treatment of Measles, the Orphan Drug Designation qualifies NanoViricides for incentives including: according to the US FDA2. There is no approved drug for the treatment of Measles. An effective Measles vaccine exists, that is generally given in 2 doses, in a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age, providing lifelong immunity. However, a vaccine does not help a patient. An effective treatment for Measles is an unmet medical need. NV-387 is the only drug candidate to our knowledge that has demonstrated strong in vivo activity against lethal infection with the Measles virus in a humanized animal model study. Cases of Measles have been rising globally for different reasons. As of Ju...

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