NanoViricides Files Orphan Drug Designation Application for Measles Treatment NV-387

NanoViricides, Inc., a clinical stage company traded on NYSE American under the symbol NNVC, announced that it has filed an application for Orphan Drug Designation (ODD) for NV-387 as a Treatment for Measles with the US FDA Office of Orphan Products Development (OOPD). The company develops broad-spectrum antivirals based on host-mimetic nanomedicine technology.

If approved, orphan drug designation will qualify NanoViricides for incentives including tax credits for qualified clinical trials, exemption from certain user fees, and potential seven years of market exclusivity after approval, according to the US FDA.

Measles cases have been rising in the USA reaching 2,251 confirmed cases with 3 deaths in 2025, from 285 in 2024 and 59 in 2023 (no deaths in these prior years). As of February 5, 2026, already 727 confirmed measles cases were reported in the United States in 2026. Vaccine breakthrough accounted for 6-7% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status. Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases, which qualifies NV-387 for Measles Treatment as an Orphan Drug indication.

A company executive stated that treating a patient and providing the drug prophylactically to contacts would eliminate the need for quarantine and loss of valuable school time, and that an Orphan Drug Designation would help tremendously in the mission of regulatory development and approval of NV-387 to treat Measles.

NanoViricides employed the expert services of Only Orphans Cote, LLC, a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application. Dr. Timothy Cote previously served as the Director of US FDA Office of Orphan Products Development (OOPD), and has intimate knowledge of the laws, rules, and regulations, governing orphan drugs, and the potential benefits to the Drug Sponsors.

There is no approved drug for the treatment of measles, although an effective vaccine exists and is generally given in a combination of 3 or 4 vaccines (MMR or MMRV) at one year of age providing lifelong immunity. Measles is a highly contagious disease. A population vaccination rate of more than 95% is thought to be needed for blocking spread of measles if a case occurs. Vaccination rates have been dropping worldwide primarily due to vaccine hesitancy.

Only an effective treatment can help the patient and can avoid the potential severe disease scenarios such as encephalitis, neurological disabilities, and potential fatalities as well as immune amnesia that can result from severe disease.

In absence of a treatment, quarantining of all contacts of a case for at least 14 days is the public health approach at present to minimize spread. Vaccination is urged but any vaccine requires 2-3 weeks from administration to become effective. Also, Measles vaccine requires 2 doses spread apart in time for full effectiveness.

Quarantining causes significant disturbances in the society, in particular, causing significant loss of in-school days for children. A preventive NV-387 treatment of contacts would eliminate the need for quarantining, with a significant positive impact for children as well as economically.

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.

Measles cases are rising across the Western world including several European countries and the UK, as well as the USA and Canada. Additionally Mexico and several other Central and South American countries have also been suffering from rising Measles outbreaks. Measles is endemic in the developing and less developed nations.

NV-387 is an unusually broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.

NanoViricides, Inc. is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide class of drug candidates and the nanoviricide technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc.