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

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.

Measles cases have been rising in the USA as well. As of June 26, 2026, already 2,122 confirmed Measles cases (excluding 12 in international travelers) were reported in the United States in 2026 (no deaths). In the year 2025, 2,263 confirmed cases (excluding 25 in international travelers) with 3 deaths were reported. Vaccine breakthrough (i.e. cases in vaccinated persons) accounted for 7-8% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status. (CDC data⁴).

Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases. Measles primarily affects children. These facts have qualified NV-387 for Measles Treatment for an Orphan Drug Designation, and also for a Rare Pediatric Disease Drug Designation. In a rare disease scenario, commercial revenue from the drug may be slow and small. The PRV is designed to incentivize drug development for rare pediatric diseases by providing additional business value.

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 globally; many countries that had achieved an elimination status for Measles have by now lost this status, due to severe outbreaks over the last three years⁵.

Measles is a highly contagious disease, and spreads via virus particles in bodily fluids upon close contact. A population vaccination rate of at least 95% is required to provide "herd immunity" and block community spread. Such a high rate is difficult to maintain for several reasons. Firstly, vaccine hesitancy is rising globally. Secondly, persons with co-morbidities such as immune-compromise status, diabetes, obesity, etc. do not respond fully to any vaccination. Even if vaccinated, such a person can still get Measles, suffering from possibly a mild disease, but will still be contagious and spread Measles. Additionally, the Measles virus continues to change, with the B and D genotypes in circulation currently, while the vaccines in use are still the ones developed for the A genotype in the 1960's.

Further, very high rates of infections in vaccinated subjects (called "breakthrough cases"), from 14% to 57%, have occurred in some outbreaks⁶ suggesting that resistant virus strains may have been involved.

Therefore, an effective treatment for Measles is an unmet medical need, that is expected to become even more important in the near future than it is today. 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.

Quicker recovery of a patient means less chances for spread and thus better ability to control an outbreak. This would require an effective treatment.

NanoViricides employed the expert services of Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote, for developing the ODD application as well as the RPDD application for Measles. Dr. 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.

NV-387 is an extremely 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.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) 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. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

¹ https://prvwatch.com/

² https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products

³ https://telanganatoday.com/bangladesh-measles-outbreak-claims-seven-more-lives-death-toll-rises-to-709.

⁴ https://www.cdc.gov/measles/data-research/index.html

⁵ https://www.cfr.org/articles/many-countries-eliminated-measles-why-is-it-coming-back-in-the-u-s-and-globally

⁶ Fappani,et al. Breakthrough Infections: A Challenge towards Measles Elimination?. Microorganisms 2022, 10, 1567. https://doi.org/10.3390/microorganisms10081567

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

S.Weaver--TFWP