Measles Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides
Rhea-AI Summary
NanoViricides (NYSE:NNVC) filed an application for Orphan Drug Designation (ODD) with the FDA for NV-387 as a treatment for measles on February 10, 2026. The company cites rising measles cases (2,251 cases in 2025; 727 cases as of Feb 5, 2026) and says NV-387 showed strong in vivo activity in a humanized animal model. If granted, ODD could provide tax credits, fee exemptions, and up to seven years of market exclusivity.
Positive
- FDA Orphan Drug application filed for NV-387 to treat measles
- Potential incentives: tax credits, user-fee exemptions, up to seven years exclusivity
- In vivo activity reported: NV-387 effective in humanized animal measles model
- Company targeting Phase II advancement for NV-387 across multiple viral indications
Negative
- Orphan Drug Designation is an application only; approval is not guaranteed
- Company warns drug development is lengthy and requires substantial capital
- IND timing uncertain due to dependence on external collaborators and consultants
Key Figures
Market Reality Check
Peers on Argus
NNVC was up 6.25% pre-news while peers were mixed: XCUR up 8.66%, QTTB, FBLG, LIXT modestly down and SABS nearly flat, indicating a stock-specific move rather than a broad biotech rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Phase II MPox approval | Positive | -8.7% | ACOREP cleared start of Phase II NV‑387 trial for MPox in DRC. |
| Oct 15 | Dual-track strategy | Positive | +6.7% | Outlined dual Phase II strategy for MPox and acute respiratory viruses. |
| Aug 18 | Cancer-metastasis angle | Positive | +2.0% | Linked NV‑387’s anti‑inflammatory effects to potential cancer metastasis benefits. |
| Jul 14 | MPox trial design | Positive | +14.7% | Detailed adaptive Phase II MPox protocol using NV‑387 oral gummies in DRC. |
| Jul 01 | Phase II MPox plan | Positive | +0.0% | Announced business case and plans to advance NV‑387 into Phase II for MPox. |
Clinical/clinical‑strategy updates for NV‑387 have usually led to positive or flat next‑day moves, with one notable negative reaction despite positive trial progress.
Over the last six months, NNVC has repeatedly highlighted NV‑387’s clinical progress and broad-spectrum profile. Prior clinical‑tag releases covered Phase I completion, Phase II trial design for MPox, dual‑track strategy for MPox and respiratory viruses, and regulatory approval by ACOREP to start a Phase II MPox trial. Most of these events saw positive or stable price reactions, suggesting the market often responds constructively to clear advancement steps like today’s measles ODD filing.
Historical Comparison
Clinical‑tag NV‑387 updates have averaged a 2.93% move. Today’s 6.25% pre‑news gain is above that typical reaction for similar clinical milestones.
Clinical‑tag history shows NV‑387 progressing from completed Phase I into multiple Phase II designs and approvals for MPox and respiratory infections, with today’s measles ODD filing extending the program’s orphan‑strategy footprint.
Regulatory & Risk Context
An effective S-3 shelf filed on Dec 15, 2025 registers up to 7,142,858 warrant‑underlying shares for resale. Full cash exercise of these warrants could generate about $13.4 million for the company, while resale proceeds go to the selling stockholder. The filing also notes an auditor paragraph citing substantial doubt about continued going concern.
Market Pulse Summary
This announcement extends NV‑387’s strategy into measles via a US FDA orphan drug designation application, leveraging rising case counts yet incidence levels below 200,000 annually. It complements prior Phase II plans for MPox and respiratory viruses. Context from recent filings highlights substantial doubt about going concern and an effective S‑3 tied to warrant exercises, so upcoming capital decisions and tangible Phase II trial progress remain key metrics to monitor.
Key Terms
orphan drug designation regulatory
office of orphan products development regulatory
in vivo medical
humanized animal model medical
clinical trials medical
AI-generated analysis. Not financial advice.
SHELTON, CONNECTICUT / ACCESS Newswire / February 10, 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, announced today 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).
If approved, 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 (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products).
"NV-387, as an effective drug would be an important tool to fight Measles resurgence in the USA and worldwide, when approved," said Anil R. Diwan, PhD, adding, "Treating a patient and providing the drug prophylactically to contacts would eliminate the need for quarantine and loss of valuable school time. An Orphan Drug Designation would help us tremendously in the mission of regulatory development and approval of NV-387 to treat Measles."
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
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. 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
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.
Thus, a drug for Measles is sorely needed for combating Measles worldwide.
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. (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
SOURCE: NanoViricides, Inc.
View the original press release on ACCESS Newswire
FAQ
What did NanoViricides announce about NV-387 and measles on February 10, 2026 (NNVC)?
What benefits could NV-387 receive if FDA grants Orphan Drug Designation for measles (NNVC)?
Has NV-387 shown efficacy against measles in preclinical studies (NNVC)?
Does measles meet orphan disease criteria for NV-387 (NNVC)?
What are the main development risks for NV-387 described by NanoViricides (NNVC)?
