The Fort Worth Press - NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA

The orphan drug designation will qualify 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 FDA^[1].

"The Orphan Drug Designation is an important milestone that will help us speed up the regulatory development of NV-387 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."

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 have been rising globally. This year, a major epidemic has broken out in Bangladesh with over 227 children dead and over 35,000 cases, while Guatemala has an on-going Measles outbreak with over 5,300 cases and four deaths^[2].

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 years^[3].

Measles cases have been rising in the USA. As of April 30, 2026, already 1,803 confirmed measles cases (excluding 11 in international travelers) were reported in the United States in 2026. in the year 2025, 2,251 confirmed cases with 3 deaths were reported, increasing from 285 in 2024 and 59 in 2023 (no deaths in these prior years). Vaccine breakthrough accounted for 6-7% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status. (CDC data^[4]).

Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases, which has qualified NV-387 for Measles Treatment as an Orphan Drug indication.

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. 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.

In addition to the ODD, NanoViricides has also applied for a "Rare Pediatric Disease Drug" (RPDD) designation for NV-387 as a Treatment of Measles to the OOPD. The RPDD, if granted would additionally enable the Company eligible for a "Priority Review Voucher" (PRV). A PRV cuts the FDA review time for the corresponding NDA significantly. A PRV is tradable, and it has fetched $150~200 million dollars to the holder when traded. A PRV would provide a significant early revenue source for the Company, and would make a strong business case for prioritizing the development of NV-387 for Measles.

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 could eliminate the need for quarantining, with a significant positive impact for children as well as economically.

Thus, a drug for Measles is sorely needed for combating Measles worldwide.

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

^[2] https://www.cidrap.umn.edu/measles/measles-case-counts-mount-utah-arizona-while-bangladesh-guatemala-battle-deadly-outbreaks (May 1, 2026, CIDRAP news).

^[3] https://www.cfr.org/articles/many-countries-eliminated-measles-why-is-it-coming-back-in-the-u-s-and-globally

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

SOURCE: NanoViricides

View the original press release on ACCESS Newswire

T.Dixon--TFWP