NanoViricides (NYSE-A:NNVC), a clinical-stage biotechnology company developing broad-spectrum antivirals, said on Tuesday it has filed an application with the US Food and Drug Administration (FDA) for Orphan Drug Designation for its experimental drug NV-387 as a treatment for measles.
If granted, the designation would provide the company with incentives including tax credits for qualified clinical trials, exemptions from certain FDA user fees, and potential seven-year market exclusivity following approval.
“NV-387, as an effective drug, would be an important tool to fight measles resurgence in the USA and worldwide,” said NanoViricides executive chairman Anil Diwan. He added that the drug could help avoid quarantines and minimize school absences by treating patients and prophylactically protecting contacts.
Measles cases in the United States have surged, with 2,251 confirmed cases and three deaths reported in 2025, up from 285 cases in 2024 and 59 in 2023.
Currently, there is no approved drug treatment for measles. Vaccination remains the primary preventive measure, though full immunity requires two doses spaced apart in time.
NV-387 is described by the company as a broad-spectrum antiviral that has shown strong in vivo activity against lethal measles infection in humanized animal models. The drug has also demonstrated efficacy against other viral infections, including respiratory syncytial virus (RSV), COVID-19, influenza, smallpox, Mpox, and measles.
The company engaged regulatory consultant Only Orphans Cote, LLC, founded by former FDA Orphan Products Development director Dr Timothy Cote, to support the ODD application.