MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides

Rhea-AI Summary

NanoViricides (NYSE American: NNVC) filed an application on February 12, 2026 for Orphan Drug Designation with the US FDA OOPD for NV-387 as a treatment for MPox. The filing cites qualifying incidence (~2,042 cases in 2025) and seeks incentives including tax credits, user-fee exemptions, and potential seven years of market exclusivity if approved.

The company notes NV-387 completed a Phase I safety trial with no reported adverse events and showed efficacy in relevant animal models. NanoViricides engaged regulatory consultant Only Orphans Cote for the ODD submission.

Positive

• ODD application filed with FDA on Feb 12, 2026
• Phase I safety completed with no reported adverse events
• Animal efficacy demonstrated in orthopoxvirus models
• Qualifies for ODD based on ~2,042 MPox cases in 2025

Negative

• Orphan designation is applied for, not granted; benefits are conditional
• No clinical efficacy in MPox shown yet; only Phase I safety completed
• Low US incidence (2,042 cases) could limit immediate commercial market

Key Figures

Market exclusivity: 7 years US MPox cases: 2,042 cases ODD incidence threshold: 200,000 cases +5 more

8 metrics

Market exclusivity 7 years Potential orphan drug exclusivity period after approval

US MPox cases 2,042 cases Approximate MPox incidence in USA in 2025

ODD incidence threshold 200,000 cases US prevalence cap for Orphan Drug Designation eligibility

Reported adverse events 0 events Phase I NV-387 human trial safety and tolerability in healthy adults

WHO PHEIC year 2022 Initial WHO Public Health Emergency of International Concern for MPox

New PHEIC declared August 2024 WHO declaration for MPox Clade Ia/Ib in African region

PHEIC ended September 2025 End of second WHO MPox PHEIC period

Smallpox eradication year 1980 Year WHO declared global eradication of smallpox

Market Reality Check

Price: $1.01 Vol: Volume 174,975 is below t...

low vol

$1.01 Last Close

Volume Volume 174,975 is below the 20-day average of 288,876 (relative volume 0.61x). low

Technical Shares at $1.01 are trading below the 200-day MA of $1.40 and 54.71% under the 52-week high.

Peers on Argus

Pre-news, NNVC was flat while biotech peers were mixed: several down (e.g., QTTB...

Pre-news, NNVC was flat while biotech peers were mixed: several down (e.g., QTTB -9.04%, XCUR -3.3%, FBLG -3.01%, SABS -0.48%) and LIXT up 10.07%, indicating stock-specific rather than clear sector-driven dynamics.

Previous Clinical trial Reports

5 past events · Latest: Feb 10 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 10	Measles ODD filing	Positive	+8.0%	Filed FDA orphan drug application for NV-387 as measles treatment.
Nov 10	MPox Phase II approval	Positive	-8.7%	DRC’s ACOREP approved start of NV-387 Phase II MPox trial.
Oct 15	Dual-track strategy	Positive	+6.7%	Outlined NV-387 dual-track Phase II plan for MPox and respiratory viruses.
Aug 18	Cancer-metastasis angle	Positive	+2.0%	Reported NV-387’s anti-inflammatory benefits and Phase II advancement plans.
Jul 14	MPox trial design	Positive	+14.7%	Detailed adaptive Phase II MPox trial design using NV-387 oral gummies.

Pattern Detected

Clinical/ODD-style NV-387 updates have often led to positive moves, but reactions have been mixed with at least one sharp selloff on good clinical news.

Recent Company History

Over the last few quarters, NanoViricides has repeatedly highlighted NV-387’s clinical progression and strategy. Prior clinical trial-tagged events include Phase II protocol work for MPox, dual-track development for respiratory infections, and regulatory approvals such as ACOREP’s Phase II clearance in the DRC. The recent measles ODD filing on Feb 10, 2026 drew a +8.02% reaction. Today’s MPox ODD application extends that orphan-focused strategy around the same lead asset.

Historical Comparison

clinical trial

+4.5 %

Average Historical Move

Historical Analysis

In the past 6 months, NNVC issued 5 clinical trial-tagged NV-387 updates. Average 24h move was 4.54%, with mostly positive reactions but one notable selloff after MPox Phase II approval.

Typical Pattern

Same-tag history shows NV-387 progressing from completed Phase I safety, through protocol design and ethics/regulatory approvals for Phase II MPox and respiratory trials, and now layering on orphan drug strategies across MPox and measles.

Regulatory & Risk Context

Active S-3 Shelf · $13.4 million

Shelf Active

Active S-3 Shelf Registration 2025-12-15

$13.4 million registered capacity

An effective S-3 shelf dated Dec 15, 2025 registers up to 7,142,858 shares for resale tied to Series A and B warrants. If fully exercised for cash at $1.75 and $2.00, these warrants could generate approximately $13.4 million in gross proceeds, though resale itself does not raise funds for the company.

Market Pulse Summary

This announcement extends NanoViricides’ NV-387 strategy by seeking US FDA orphan drug designation f...

Analysis

This announcement extends NanoViricides’ NV-387 strategy by seeking US FDA orphan drug designation for MPox, building on prior MPox and measles efforts and completed Phase I safety data with 0 reported adverse events. Historically, similar clinical trial-tagged updates have produced mixed price reactions. Investors may watch for FDA ODD decisions, concrete Phase II enrollment progress, and how the company manages capital needs under its existing S-3 and warrant structures.

Key Terms

orphan drug designation, us fda, office of orphan products development, public health emergency of international concern, +3 more

7 terms

orphan drug designation regulatory

"announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox""

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

us fda regulatory

"with the US FDA Office of Orphan Products Development (OOPD)"

The U.S. Food and Drug Administration is the federal agency that reviews and authorizes drugs, medical devices, vaccines, and certain foods and cosmetics for safety and effectiveness before they can be marketed in the United States. Think of it as a regulatory gatekeeper whose approvals, rejections or required additional tests can dramatically change a product’s sales potential, launch timing and risk profile—making FDA decisions a key driver of investor value and company prospects.

office of orphan products development regulatory

"with the US FDA Office of Orphan Products Development (OOPD)"

A government office that reviews and approves special status for medicines, devices and related products aimed at rare diseases affecting small patient groups, and that administers related incentives and grant programs. Investors care because its decisions can unlock regulatory benefits—such as market exclusivity, tax credits and development funding—that lower costs, extend sales opportunities and materially affect a product’s commercial value; think of it as a small-business support office that helps niche treatments reach the market.

public health emergency of international concern regulatory

"WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022"

A public health emergency of international concern is an official alarm declared by the World Health Organization when a disease outbreak poses a serious risk across countries and needs coordinated global action. Think of it like a neighborhood-wide fire alarm that prompts governments to share information, recommend travel or trade measures, and mobilize medical resources—actions that can quickly affect supply chains, consumer demand, regulation and market volatility, so investors watch these declarations closely.

pheic regulatory

""Public Health Emergency of International Concern" (PHEIC) for MPox in 2022"

A PHEIC (Public Health Emergency of International Concern) is a formal declaration by global health authorities that an outbreak poses a serious risk across borders and requires coordinated international action. For investors, a PHEIC is like a loud alarm that can trigger rapid policy responses, travel and trade disruptions, supply-chain strains and shifts in consumer behavior, all of which can quickly affect company revenues, costs and market sentiment.

animal rule regulatory

"brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule""

A regulatory pathway that allows safety and effectiveness of drugs or vaccines to be judged primarily from well-controlled animal studies when human trials would be unethical or impossible, such as for treatments against rare, lethal exposures. It matters to investors because approval via this route can speed a product to market for urgent or niche needs but carries extra scientific and regulatory risk—think of it as accepting a high-quality dress rehearsal instead of a live show, with requirements for strong animal models and often additional post-approval obligations.

nanomedicine medical

"broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape"

Nanomedicine uses extremely tiny engineered materials and devices — often measured in billionths of a meter — to diagnose, monitor, or treat disease, for example by delivering drugs directly to specific cells or enhancing imaging. For investors it signals a high-tech approach with the potential for more effective therapies, smaller doses, and new product categories, but also brings specialized manufacturing, regulatory scrutiny, and research risk that can affect development timelines and returns.

AI-generated analysis. Not financial advice.

SHELTON, CONNECTICUT / ACCESS Newswire / February 12, 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 MPox" 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 MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat."

WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus.

MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern.

There is no approved drug for the treatment of MPox. Tecovirimat (TPOXX®, SIGA) and brincidofovir (TEMBEXA®, EBS) were approved by the US FDA for Smallpox, both under the "Animal Rule". Tecovirimat has failed to show any clinical effectiveness, and did not show any viral load reduction benefit either, over standard of care in a clinical trial for treatment of MPXV infections¹. Mutants resistant to tecovirimat were found to be generated in some cases. Brincidofovir treatment resulted in drug-induced liver disease in three out of three treated MPox patients resulting in cessation of therapy, and did not show any effectiveness in these patients according to a peer reviewed "retrospective observational study" also called "non-randomized study"². In spite of this, a clinical trial of brincidofovir for treating MPox was initiated under an international coalition led by US CDC and first patient was dosed around January 2025 in this "MOSA" clinical trial³. The topline results from this clinical trial regarding safety and efficacy were anticipated by CY Q2 (i.e. June, 2025). We have not found any press releases announcing any such results.

The orthopoxviruses can escape both small chemical drugs, tecovirimat and brincidofovir, by mutations, according to peer reviewed scientific articles⁴.

MPXV has continued to mutate in the African region. Mutants resistant to the JYNNEOS® Smallpox vaccine that was fielded to control the spread of MPXV Clade Ia/Ib have been found. The antibody response to MPXV from the JYNNEOS vaccine was found to be poor and short-lived⁵.

The above factors clearly highlight the need for an effective therapeutic for the treatment of MPOX.

NV-387 has shown strong effectiveness in a mouse model of dermal lethal infection of ectromelia, an orthopoxvirus closely related to viruses that cause smallpox and mpox. NV-387 has successfully completed a Phase I human clinical trial demonstrating safety and tolerability in healthy adults with no reported adverse events. Therefore the Company believes that NV-387 is a viable clinical candidate for the treatment of MPox.

In the USA, MPOX incidence rate was approximately 2,042 cases in 2025, well below 200,000 cases⁶. Thus NV-387 for the Treatment of MPox qualifies for Orphan Drug Designation.

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.

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.

Viral resistance to NV-387 is unlikely because this drug mimics specific cell-side features that these viruses continue to employ to effectively infect human host cells, despite how much they may change in the field. In contrast, viruses mutations readily result in making traditional vaccines, antibodies, and small chemical drugs ineffective.

Further, NV-387 is a complete chemical nanomachine that completes the task of binding to, engulfing, and destroying virus particles without any dependence on the human immune system.

These factors make NV-387 unique in the field of antiviral drugs and vaccines.

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.
info@nanoviricides.com

Public Relations Contact:
ir@nanoviricides.com

¹The PALM007 Writing Group, "Tecovirimat for Clade I MPXV Infection in the Democratic Republic of Congo", N Engl J Med 2025;392:1484-96. DOI: 10.1056/NEJMoa2412439.

²Adler H. et al., "Clinical features and management of human monkeypox: a retrospective observational study in the UK", Lancet Infect Dis 2022; 22: 1153-62, Published Online May 24, 2022, corrected May 26, https://doi.org/10.1016/ S1473-3099(22)00228-6. NHS England High Consequence Infectious Diseases (Airborne) Network .

³https://mpx-response.eu/treating-mpox-in-africa-mosa-begins-patient-enrollment-in-drc/.

⁴Becker et al - RW Moyer group "Isolation and characterization of cidofovir resistant vaccinia viruses", Virology Journal 2008, 5:58 doi:10.1186/1743-422X-5-58. Brincidofovir is a prodrug of cidofovir, which means cellular enzymes convert it to cidofovir.

⁵Phipps, K. et al. "Short-Lived Neutralizing Antibody Responses to Monkeypox Virus in Smallpox Vaccine-Naive Persons after JYNNEOS Vaccination." Wadsworth Center, New York State Department of Health and Univ. of Albany, NY. Emerging Infectious Diseases • www.cdc.gov/eid • Vol. 31, No. 2, February 2025. DOI: https://doi.org/10.3201/eid3102.241300 .

⁶https://www.cdc.gov/monkeypox/data-research/cases/index.html.

SOURCE: NanoViricides, Inc.

View the original press release on ACCESS Newswire

FAQ

What did NanoViricides (NNVC) file with FDA on February 12, 2026 regarding NV-387?

They filed an Orphan Drug Designation (ODD) application for NV-387 as a treatment for MPox. According to the company, the filing cites qualifying incidence data and requests ODD incentives like tax credits and fee exemptions.

Does NV-387 have human clinical data for MPox as of February 12, 2026?

NV-387 has completed a Phase I human safety trial with no reported adverse events. According to the company, efficacy in humans for MPox has not yet been demonstrated and further trials are planned.

Why does NanoViricides (NNVC) say NV-387 qualifies for Orphan Drug Designation for MPox?

The company cites a US MPOX incidence of approximately 2,042 cases in 2025, below the orphan threshold. According to the company, that case count supports eligibility under FDA orphan criteria.

What potential benefits does Orphan Drug Designation bring for NV-387 if granted?

ODD could provide tax credits, certain user-fee exemptions, and up to seven years of market exclusivity post-approval. According to the company, these incentives would aid clinical development and commercialization planning.

Has NV-387 shown effectiveness against MPox in laboratory or animal studies?

NV-387 demonstrated strong effectiveness in a mouse model of dermal lethal ectromelia infection, an orthopoxvirus model. According to the company, these results support NV-387 as a clinical candidate for MPox.

What are the near-term development steps for NV-387 after the ODD filing by NNVC?

Next steps include potential FDA review of the ODD request and progressing NV-387 into further clinical trials. According to the company, advancement toward Phase II human studies is a current focus.