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:
Tax credits for qualified clinical trials;
Exemption from certain user fees;
Potential seven years of market exclusivity after approval;
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 June 28, 2026, an epidemic of Measles that began in March in Bangladesh has so far caused deaths of at least 709 children, with 98,266 suspected cases. Laboratory testing is sparse, whereby confirmed deaths are 94, and confirmed infections are 11,594, according to the Directorate General of Health Services of Bangladesh (DGHS)3.