While Measles Cases Continue to Increase in The USA and Globally, NanoViricides is Getting Ready for Clinical Trials of Its Revolutionary Broad-spectrum Drug Candidate NV-387 as A Treatment for Measles
Rhea-AI Summary
NanoViricides (NYSE American: NNVC) reported progress in its measles treatment program, highlighting broad-spectrum antiviral candidate NV-387. NV-387 has shown strong in vivo activity against lethal measles infection in a humanized animal model and is being advanced toward a Phase II clinical trial under an IND process with the US FDA.
According to NanoViricides, NV-387 has received both Orphan Drug Designation (ODD) and Rare Pediatric Disease Drug (RPDD) designation from the FDA for measles, making the company eligible for incentives such as tax credits, user-fee exemptions, potential seven-year market exclusivity, and a potential Priority Review Voucher (PRV), which the company notes have recently sold for about $195 million.
Positive
- NV-387 preclinical measles efficacy – strong in vivo activity against lethal measles in a humanized animal model
- Regulatory designations – NV-387 has both Orphan Drug and Rare Pediatric Disease Drug designations for measles
- Potential Priority Review Voucher – RPDD status makes NV-387 eligible for a PRV upon successful approval
- Economic upside from PRV – company cites a recent PRV sale for approximately $195 million as a benchmark
- Additional FDA incentives – eligibility for tax credits, user-fee exemptions, and up to seven years market exclusivity after approval
- Broad development pipeline – NV-387 also planned for RSV, COVID, Long COVID, influenza, and MPOX/smallpox indications
Negative
- No approved measles drug – measles still lacks any approved antiviral treatment, indicating high unmet need
- Clinical stage timing uncertainty – company cannot project an exact IND filing date due to reliance on external collaborators and consultants
- Phase II not yet initiated – NV-387 is in protocol development for Phase II measles trials, with timelines unspecified
- Limited rare-disease revenue expected – company notes commercial revenue for measles could be slow and small given its rare-disease status
News Explained
NV-387’s measles program is still pre-IND: a Phase II draft is circulating, with no trial start, approval, or PRV proceeds disclosed.
NanoViricides reports that its NV-387 measles program remains at the protocol-development stage: a draft Phase II plan is circulating, and the company intends to take it into the US FDA’s IND process. The disclosed consequence is additional regulatory and trial-planning work, not a stated change in existing holders’ ownership.
In the release, placing the protocol under the FDA’s IND process is a planned regulatory step, while the company’s wording does not report an approved IND or a commenced human trial.
The release’s cash discussion is conditional: any Priority Review Voucher proceeds would require a successful marketing application, issuance of the voucher, and its sale, so no such cash is disclosed now.
The next specific milestone is the draft protocol’s progression into the FDA IND process; the company says that work is expected to take some time and that it cannot project an exact filing date.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 18 | Phase II trial update | Positive | -0.7% | DR Congo regulator approved Ebola trial; dosing was anticipated within weeks. |
| Aug 10 | Phase II trial approval | Positive | -1.4% | ACOREP approved the Ebola trial and NV-387 product was positioned in DRC. |
| Jul 28 | Phase II trial preparation | Positive | +4.5% | Company awaited Ebola trial approval after completing financing for anticipated expenses. |
| Jul 24 | Registered direct offering | Negative | -3.3% | Company priced approximately $3.8 million of shares and accompanying warrants. |
| Jul 22 | Phase II trial application | Positive | -5.0% | Company applied for Ebola trial approval with drug product already in DRC. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial announcements in the selected history generally had negative 24-hour reactions despite reported development progress.
Key Terms
rare pediatric disease drug designation regulatory
priority review voucher regulatory
orphan drug designation regulatory
herd immunity medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
SHELTON, CT / ACCESS Newswire / August 31, 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, provides an update on its Measles Drug Treatment Program.
While CDC is reviewing the two recent measles-related fatalities in Pennsylvania, the total number of confirmed measles cases in the USA has reached 2,903 as of August 27, 2026, in comparison to 2,289 confirmed cases in the whole year of 2025, indicating continuing expansion of measles1. Cases of Measles have been rising globally for different reasons. The measles outbreak in Bangladesh has continued to proliferate, claiming 19,218 confirmed cases with 99 fatalities in confirmed cases from 15 March to 30 August, 2026. During this period, a total of 1,37,347 patients with suspected measles were admitted to hospitals and 868 children have died of suspected measles, whereas 1,151 suspected measles cases with 4 deaths were reported in just the last 24 hours in Bangladesh2. The measles outbreak in Bangladesh has continued despite aggressive vaccination campaign that was undertaken since April-May 2026.
In the USA, since COVID-19 days, the MMR vaccination rate has fallen from
There is currently no approved drug for measles. Vaccine does not help a patient already infected with the measles virus. Vaccinating already measles-exposed persons to avoid disease spread is attempted yet measles has continued to spread in the USA.
Thus 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.
NanoViricides is currently developing a Phase II clinical trial protocol for evaluating NV-387 as a treatment for measles. A draft is being circulated. The Company intends to bring this protocol under the purview of the US FDA in an IND process. Therefore, this work is expected to take some time.
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
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 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 FDA4.
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
Further, very high rates of infections in vaccinated subjects (called "breakthrough cases"), from
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.
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.
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.
info@nanoviricides.com
Public Relations Contact:
ir@nanoviricides.com
6 Fappani,et al. Breakthrough Infections: A Challenge towards Measles Elimination?. Microorganisms 2022, 10, 1567. https://doi.org/10.3390/microorganisms10081567
SOURCE: NanoViricides
View the original press release on ACCESS Newswire