NanoViricides Discusses the Multi-Billion-Dollar Potential of Its Broad-Spectrum Drug NV-387; Its Effectiveness Against Influenza, Coronaviruses, RSV, MPox and Now Measles Expected to Drive Value
NanoViricides (NYSE:NNVC) has detailed the significant market potential of its broad-spectrum antiviral drug NV-387, which has shown effectiveness against multiple viruses including Influenza, Coronaviruses, RSV, MPox, and Measles. The company is advancing toward a Phase II clinical trial for MPox treatment, where NV-387 could become the first approved drug for this indication.
The drug's potential extends to pandemic preparedness, with possible effectiveness against Ebola/Marburg and Hendra/Nipah viruses. The company plans to pursue orphan drug status for several indications and may be eligible for Priority Review Vouchers worth $150-250 million each. NV-387's unique mechanism mimics HSPG, a cell-side molecule that over 90% of human pathogenic viruses bind to, making viral escape unlikely.
NanoViricides (NYSE:NNVC) ha illustrato il notevole potenziale di mercato del suo farmaco antivirale ad ampio spettro NV-387, che ha dimostrato efficacia contro diversi virus tra cui Influenza, Coronavirus, RSV, MPox e Morbillo. L'azienda sta procedendo verso una fase II di sperimentazione clinica per il trattamento del MPox, dove NV-387 potrebbe diventare il primo farmaco approvato per questa indicazione.
Il potenziale del farmaco si estende anche alla preparazione contro pandemie, con una possibile efficacia contro virus come Ebola/Marburg e Hendra/Nipah. L'azienda intende richiedere lo status di farmaco orfano per diverse indicazioni e potrebbe essere idonea a ricevere Priority Review Vouchers del valore di 150-250 milioni di dollari ciascuno. Il meccanismo unico di NV-387 imita l'HSPG, una molecola presente sulla superficie cellulare a cui si legano oltre il 90% dei virus patogeni umani, rendendo difficile l'evasione virale.
NanoViricides (NYSE:NNVC) ha detallado el importante potencial de mercado de su medicamento antiviral de amplio espectro NV-387, que ha demostrado eficacia contra múltiples virus, incluidos Influenza, Coronavirus, RSV, MPox y Sarampión. La compañía avanza hacia un ensayo clínico de Fase II para el tratamiento de MPox, donde NV-387 podría convertirse en el primer medicamento aprobado para esta indicación.
El potencial del fármaco también abarca la preparación para pandemias, con posible eficacia contra los virus Ébola/Marburg y Hendra/Nipah. La empresa planea solicitar el estatus de medicamento huérfano para varias indicaciones y podría ser elegible para Vales de Revisión Prioritaria valorados en 150-250 millones de dólares cada uno. El mecanismo único de NV-387 imita el HSPG, una molécula en la superficie celular a la que se unen más del 90% de los virus patógenos humanos, lo que hace improbable la evasión viral.
NanoViricides (NYSE:NNVC)는 인플루엔자, 코로나바이러스, RSV, MPox, 홍역 등 여러 바이러스에 효과를 보인 광범위 항바이러스제 NV-387의 상당한 시장 잠재력을 상세히 밝혔습니다. 회사는 MPox 치료를 위한 2상 임상시험을 진행 중이며, NV-387는 이 적응증에 대해 최초 승인 약물이 될 수 있습니다.
이 약물의 잠재력은 에볼라/마르부르그, 헨드라/니파 바이러스 등 팬데믹 대비에도 확장됩니다. 회사는 여러 적응증에 대해 희귀의약품 지정을 추진할 계획이며, 각각 1억 5천만에서 2억 5천만 달러 가치의 우선 심사 바우처 자격을 얻을 수 있습니다. NV-387의 독특한 작용 기전은 인간 병원성 바이러스의 90% 이상이 결합하는 세포 표면 분자 HSPG를 모방하여 바이러스의 회피를 어렵게 만듭니다.
NanoViricides (NYSE:NNVC) a détaillé le potentiel de marché important de son médicament antiviral à large spectre NV-387, qui a montré son efficacité contre plusieurs virus, notamment la grippe, les coronavirus, le VRS, le MPox et la rougeole. La société progresse vers un essai clinique de phase II pour le traitement du MPox, où NV-387 pourrait devenir le premier médicament approuvé pour cette indication.
Le potentiel du médicament s'étend également à la préparation aux pandémies, avec une efficacité possible contre les virus Ebola/Marburg et Hendra/Nipah. La société prévoit de demander le statut de médicament orphelin pour plusieurs indications et pourrait être éligible à des bons de révision prioritaire d'une valeur de 150 à 250 millions de dollars chacun. Le mécanisme unique de NV-387 imite le HSPG, une molécule présente à la surface des cellules à laquelle plus de 90 % des virus pathogènes humains se lient, rendant l'échappement viral improbable.
NanoViricides (NYSE:NNVC) hat das bedeutende Marktpotenzial seines Breitband-Antiviralen Medikaments NV-387 vorgestellt, das gegen mehrere Viren wie Influenza, Coronaviren, RSV, MPox und Masern wirksam ist. Das Unternehmen schreitet in Richtung einer Phase-II-Studie zur Behandlung von MPox voran, bei der NV-387 das erste zugelassene Medikament für diese Indikation werden könnte.
Das Potenzial des Medikaments erstreckt sich auch auf die Pandemievorsorge, mit möglicher Wirksamkeit gegen Ebola/Marburg und Hendra/Nipah-Viren. Das Unternehmen plant, für mehrere Indikationen den Orphan-Drug-Status zu beantragen und könnte für Priority Review Vouchers im Wert von 150-250 Millionen US-Dollar pro Stück in Frage kommen. Der einzigartige Wirkmechanismus von NV-387 ahmt HSPG nach, ein zellseitiges Molekül, an das über 90 % der humanpathogenen Viren binden, wodurch eine virale Flucht unwahrscheinlich wird.
- NV-387 could be the first-ever approved drug for MPox treatment
- Drug shows broad-spectrum effectiveness against multiple major viruses
- Potential eligibility for Priority Review Vouchers worth $150-250 million each
- Multiple revenue pathways through orphan drug designations
- Cost-efficient development as Phase II trials share common costs across indications
- Strong potential in multi-billion dollar pandemic preparedness market
- No exact IND filing date projected due to dependence on external collaborators
- Lengthy and capital-intensive drug development process ahead
- Success in lab results may not translate to successful clinical trials
- Multiple regulatory approvals needed for different indications
Insights
NanoViricides' NV-387 shows promise against multiple viruses, but remains early-stage with substantial clinical and regulatory hurdles ahead.
NanoViricides is advancing its lead drug candidate NV-387, touting it as a potential broad-spectrum antiviral effective against influenza, coronaviruses, RSV, MPox, measles, and potentially other viruses. The company's technology creates host-mimetic nanomedicines designed to act as decoys that bind to heparan sulfate proteoglycans (HSPG), cell-surface molecules that many viruses utilize for cellular entry.
The most significant near-term catalyst is the planned Phase II clinical trial for MPox, which could position NV-387 as potentially the first approved treatment for this indication. The company is strategically prioritizing indications like MPox, smallpox, and measles that could qualify for orphan drug designation, offering regulatory advantages and potential Priority Review Vouchers worth $150-250 million each.
However, investors should recognize several critical considerations. First, despite the company's optimistic messaging, NV-387 remains in early clinical development with substantial testing required to demonstrate safety and efficacy in humans. The press release references effectiveness in animal studies but contains no specific efficacy data or peer-reviewed validation.
Second, while the pandemic preparedness market represents a significant opportunity, success depends on generating compelling clinical data and navigating complex government procurement processes. The press release frames NV-387 as potentially superior to existing approaches but lacks comparative data against competing technologies.
Third, the company's business model relies on licensing technology from TheraCour Pharma, creating potential dependencies and royalty obligations that could impact profitability.
The broad-spectrum potential across multiple viral targets is scientifically interesting, but investors should maintain appropriate skepticism until human clinical data validates these claims and demonstrates a clear path to commercialization.
NanoViricides' strategy to position NV-387 as a multi-indication antiviral represents a calculated approach to maximize return on development investment. By targeting the same drug candidate across multiple viral diseases, the company aims to leverage shared development costs across different indications while potentially accessing multiple revenue streams.
The emphasis on MPox, smallpox, and measles as priority indications reflects strategic regulatory thinking. These indications offer three potential advantages: orphan drug designation (market exclusivity and development incentives), possible Fast-Track designation (expedited review), and eligibility for Priority Review Vouchers. This regulatory strategy could accelerate the path to initial approval and generate early value through voucher sales even before substantial commercial revenue materializes.
From a market perspective, the pandemic preparedness angle addresses a growing government priority, with multiple countries establishing specialized agencies following COVID-19. However, securing government contracts typically requires robust efficacy data, established manufacturing capacity, and extensive safety monitoring – hurdles the company has yet to clear.
The company's technology platform targeting heparan sulfate proteoglycans (HSPG) presents an interesting mechanistic approach that theoretically addresses viral mutation concerns. However, this platform remains unproven in late-stage clinical trials, and the scientific premise that viruses cannot escape this mechanism requires validation in human studies.
The press release notably lacks specific details on the company's financial position, development timeline milestones, or partnerships that might support their ambitious clinical development plans across multiple indications. This leaves significant questions about their capacity to execute on the described strategy without additional funding or strategic collaborations.
SHELTON, CONNECTICUT / ACCESS Newswire / July 23, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: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, explains that the strong effectiveness of its broad-spectrum antiviral drug against all viruses that the drug NV-387 was tested against to date will drive significant valuation for its portfolio. The Company further elucidates that the MPox, Smallpox, and Measles indications of NV-387 are expected to enable rapid regulatory development towards approval and realization of early revenues from multiple pathways.
As additional indications of NV-387 have been validated in animal studies, approvals against the multiple indications of NV-387 are expected to drive increase in overall market share that the Company can achieve once the drug is approved. The costs leading up to Phase II clinical trial would be substantially common across all indications of this same drug, improving return on investment significantly.
Additionally, NV-387 should become the drug of choice to develop and stockpile for strategic pandemic preparedness and response because of its activity against most of the viruses of concern at present: Influenza, Coronaviruses, Orthopoxviruses (Smallpox and Mpox), and Measles. The Company believes that NV-387 is likely to be effective against Ebola/Marburg viruses, Hendra/Nipah viruses, and other lethal viruses as well, based on known binding of these viruses to HSPG. In addition to the USA, UK, Europe and India have established agencies to enable pandemic preparedness and response.
Approval of NV-387 against any of the currently established indications would drive its value as a strategic tool for pandemic preparedness against a multiplicity of potential threats. Pandemic preparedness is already a multi-billlion dollar market globally, and growing, as additional countries and regions seek to fortify their public health defenses against unknown viral threats. (see further below).
To this end, the Company is moving forward to open a Phase II clinical trial to evaluate effectiveness of NV-387 to treat MPox virus infections. If the trial is successful, NV-387 will be the first ever drug to be approved for MPox [1] . There is no effective drug for MPox at present.
Such approval will also translate to NV-387 as a currently best available option for potential smallpox therapeutics as well, based on human infection data of the smallpoxvirus-related virus MPXV , rather than animal orthopoxvirus data that FDA has currently relied upon [1] .
Additionally, the Company intends to file for orphan drug status for several indications of NV-387, including MPox, Smallpox, and Measles. Each orphan drug indication in itself would result in several economic benefits, in addition to increased interactions with the FDA.
We believe some of the indications of NV-387 will be eligible for Fast-Track designation, as well as for awards of Priority Review Vouchers (PRV). A PRV is a tradable instrument that has been traded at about
The speed with which a first indication of NV-387 can be approved is estimated to be the fastest for Mpox, Smallpox, and Measles. This is because of the specific orphan drug characteristics of these diseases in the USA. This is why the Company has prioritized these indications.
The Company is continuing its work on planning of clinical trials for what are generally considered as commercially lucrative indications that include Influenza, RSV, other respiratory viruses, as well as coronaviruses.
Viruses crossing over newly into humans from other species do so only upon acquiring significant ability to bind to HSPG, the cell-side molecule that NV-387 mimics as a decoy for the viruses [2] . It is highly unlikely that bioterrorism agents would be created that can drastically infect humans and yet do not bind to HSPG.
To date, pandemic preparedness has been dominated by one-drug-one-bug philosophy. With hundreds of potential biothreats, such a strategy is too expensive and would not realize a highly effective protective shield against potential pandemics.
Besides, the medical countermeasures pursued to-date for pandemic preparedness are severely lacking in that every one of them would be readily defeated by the virus as it mutates or evolves in the field. This is one lesson that has become starkly clear after the COVID-19 pandemic.
NV-387 is expected to provide a low cost option for pandemic preparedness against a multiplicity of threats, and could become an effective first response drug for practically any viral pandemic. Over
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
[1] Tecovirimat and Brincidofovir were approved by the US FDA for Smallpox therapeutics based on animal model data generated in animal infections by animal native orthpoxviruses. Tecovirimat failed in clinical trials of MPox. Brincidofovir caused sever drug-induced liver injury (DILI) in there of three patients given the drug in case studies, not in clinical trial.
[2] It has been reported that highly pathogenic duck influenza viruses that lack or substantially lack HSPG binding ability do not cause significant pathology in other birds, nor in humans. They appear to use exclusively sialic acid-related receptors and yet have failed to infect other species. We believe these results require further investigation.
SOURCE: NanoViricides
View the original press release on ACCESS Newswire
FAQ
What viruses has NanoViricides' NV-387 shown effectiveness against?
What is the current development stage of NNVC's NV-387 drug?
How much are Priority Review Vouchers worth for NNVC's drug development?
What makes NV-387 different from other antiviral drugs?
Which indications is NanoViricides prioritizing for NV-387?
