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Hello!
New Alert: NanoViricides, Inc. (NYSE American: NNVC)
NNVC is our new NYSE breakout opportunity.
This has been a very big winner for you many times before.
For instance, following our alert in March, the company rallied +53% in 2 months.
Before that, in January, NNVC rallied +35% in about a month.
Following our alert in October, NNVC opened at 1.54 and the same day rallied +20%. Less than a week later it rallied +44%.
Following this rally, NNVC has been consolidating and could once again present increased upside potential.
The last time it had a similar chart setup, it rallied +36% in less than a week.
That was in December.
Plus, NNVC has a RSI of only 40, signaling high upside potential.
NNVC is a NYSE listed “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 “nanoviricides™ platform technology is yielding novel antiviral drug candidates against a number of challenging viral targets at a rapid pace”.
NNVC’s “most advanced candidate, NV-387, is an ultra-broad-spectrum antiviral with potential activity against most respiratory human pathogenic viruses - and more, because it emulates the attachment receptor family of sulfated proteoglycans that over 90% of human viruses utilize”.
“The overall market size of NV-387 indications is estimated to be well in excess of $10 billion.”
“NV-387 is designed to shape-shift upon binding to the virus particle, in the process disrupting the virus particle and making it incapable of infection, as a complete chemical nanomachine that destroys the virus”.
“The revolutionary broad antiviral spectrum of NV-387 is reminiscent of the dawn of antibiotics to combat bacterial infections.”
As the company further explains:
“Viruses are unlikely to escape NV-387 because no matter how much a virus evolves, it continues to utilize and require binding to sulfated proteoglycans - the very characteristic that NV-387 emulates.”
“This solves the long-standing problem of antiviral medicines, that viruses escape them.”
“Vaccines, antibodies and small chemical drugs are readily escaped by viruses as the viruses evolve in the field.”
“This has been repeatedly observed during the recent COVID-19 pandemic, as well as in the course of most of the other viral epidemics including Influenza and HIV/AIDS.”
Furthermore:
“Continued redevelopment or "updating" of vaccines necessitated by the viral escape or drift has recurrently cost billions of dollars every year for Influenza as well as COVID.”
“NV-387 promises to make such costly endeavors unnecessary, once this drug is approved by regulatory bodies.”
“NV-387 is rapidly moving towards Phase II Safety, Tolerability and Efficacy Evaluation for the Treatment of MPOX disease, in response to the continuing Public Health Emergency of International Concern in WHO African Region.”
NNVC has “received preliminary approval of the clinical protocol and the study and now we are working diligently to finish and submit the clinical trial application”.
Plus, “NV-387 was found to be highly effective against the "tripledemic" respiratory viruses, namely RSV, Influenza A, and Coronaviruses, in respective lethal animal models of lung infection. NV-387 was found to be substantially superior to existing drugs, and even resulted in complete cure in the RSV animal study.”
Further, “NV-387 has shown excellent effectiveness in lethal lung infection animal models relevant for Smallpox and MPox viruses”.
Additionally, “NV-387 has shown excellent effectiveness in lethal lung infection in a humanized (hCD150+ knock-in) mouse model by the Measles virus. Cases of Measles have been rapidly rising in the developing world including USA, Canada, UK and European countries. Measles is an important health threat because the disease can lead to "immune amnesia", wiping out pre-developed immunity against other diseases, because it attacks the immune system itself.”
Sadly, “At present, there are no generally approved drugs for the treatment of RSV, MPox, or Measles.”
“The latter two are orphan diseases in the USA and will be eligible for earning a "Priority Review Voucher" (PRV) from the US FDA plus several years of market exclusivity upon approval. Each PRV is currently thought to be worth $150 million to $350 million as a tradable asset.”
Additionally, “NV-387's success in treating MPox is expected to make it feasible to achieve US FDA regulatory approval as a Smallpox therapeutic, a much-needed drug for the US Bioterrorism defense strategy, with potential lucrative US Government and International contracts for stockpiling in the range of several hundred millions of dollars, assuming NV-387 is successful in a Phase II clinical trial for MPox treatment”.
Importantly:
“NV-387 is expected to become an "emperic therapy" for viral infections, just as antibiotics such as amoxicillin are used as emperic therapies for bacterial infections.”
“NV-387 would be the first ever drug enabling emperic antiviral therapy, and would be potentially as revolutionary to antiviral therapy as antibiotics have been to anti-bacterial therapy.”
Emperic therapy means when the patient presents to the doctor, immediately the antiviral drug can be prescribed and started without having to wait for discriminating test results as to which virus is causing the infection.
This has “tremendous benefits since antiviral drugs are most effective when given as early as possible upon viral infection”.
In addition, NNVC has “developed a clinical-ready pan-herpesvirus drug candidate, NV-HHV-1 that has shown activity against HSV-1, HSV-2 and VZV, and is expected to have activity against CMV, HHV-6, and HHV-8 as well”.
NNVC has also “developed an anti-HIV drug candidate, NV-HIV-1, that has shown strong efficacy in SCID-hu-Thy-Liv animal model of HIV infection. NV-HHV-1 mimics the landing site on cellular CD4 that is required for all HIV viruses to cause cellular infection. Thus, HIV, despite constant changes, will be unable to escape NV-HHV-1”.
“NanoViricide Platform Enables Drug Rescue, Oral Drug Delivery, and Zip-Code Specific Delivery”:
“Oral drug delivery of small chemicals, peptides (such as the GLP-a obesity drugs), and proteins is feasible by encapsulation of the guest drug into the nanoviricide polymeric micelle. The encapsulation protects the guest from metabolism thereby enabling effective drug delivery.”
“Encapsulation of a difficult or failed drug within the nanoviricide polymeric micelle can enable rescue of the drug candidate turning it into a clinically viable drug candidate, saving hundreds of millions of dollars of development work.”
“Going another step further, the nanoviricide platform technology can be customized to enable zip-code-like specific delivery of encapsulated drugs to specific tissues (e.g. non-liver targeted delivery),, cells (e.g. cancer-cell specific delivery sparing normal cells), bacteria, or viruses (e.g. NV-HHV-1, NV-HIV-1) in a fully synthetic chemistry based, scalable technology stack.”
Over the past few months, the company has announced multiple developments.
In November, the company announced:
“NanoViricides Announces Closing of $6 Million Registered Direct Offering and Concurrent Private Placement Priced at the Market Close”
Plus, the company also announced:
“NanoViricides, Inc. Has Filed its Quarterly Report - Subsequent Raise Has Fortified Fiscal Position”
As the company explains in this press release:
“During the current quarter, we have diligently continued our progress towards initiating a Phase II human safety and effectiveness clinical trial for the evaluation of NV-387 as a treatment of Monkeypox in the Democratic Republic of Congo.”
“The local regulatory agency, ACOREP, has already approved this Phase II clinical trial, subject to completion of certain requirements.”
“Africa continues to suffer from the Monkeypox epidemic, which has resulted in the Africa CDC declaring in August 2024 a "Public Health Emergency of Continental Security" (PHECS), a status that continues because this epidemic has continued to expand across national boundaries. This Mpox epidemic is driven by the more morbid and more virulent versions, Clade 1a and 1b, as compared to the 2022 outbreak that was driven by the less virulent Clade 2. The latter has become endemic in the USA and the Western World, but remains limited to sexual transmission primarily in the men-having-sex-with-men (MSM) population. The case fatality rate of Clade 1 has been between 9% to 1.5%, whereas that of Clade 2 is less than 0.3%.”
“Our objective is to bring the data from the clinical trials external to the USA and utilize it for further regulatory advancement of NV-387 against various indications under the US FDA. NV-387 has certain orphan disease as well as bioterrorism related indications.”
“Therefore, we first plan to file the appropriate Orphan Drug Designations (ODD) for NV-387 as a treatment for MPOx, Smallpox, and also for Measles. The ODD if approved provides several benefits that would accelerate the NV-387 program towards regulatory licensure. These include frequent FDA meetings and rapid decision-making. Additionally, the economic benefits include certain tax credits for R&D costs, waiver of certain PDUFA fees, and a seven year exclusivity for marketing the drug for the licensed indication.”
Most recently, in December, the company announced:
“NanoViricides Has Signed a Master Services Agreement with OnlyOrphansCote Regarding Orphan Drug Strategy of NV-387 for Treatment of MPox, Smallpox, and Measles”
“SHELTON, CONNECTICUT / ACCESS Newswire / December 1, 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, announced today that it has signed a Master Services Agreement (MSA) with Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote. Dr. Cote and OOC will help the Company formulate its orphan drug strategy for NV-387, as well as develop relevant orphan drug designation applications and prosecute these applications at the US FDA Office of Orphan Products.”
Importantly:
"In earlier discussions with Dr. Cote, it became apparent that the broad-spectrum antiviral drug NV-387 could harness several benefits from an orphan drug regulatory strategy," said Anil R. Diwan, PhD, President & Executive Chairman of the Company.
“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.”
As the company further notes:
“NV-387 has demonstrated excellent activity against lethal animal models of orthopoxvirus ectromelia infections in mice. This opens up the regulatory pathway for licensure of NV-387 for the treatment of Smallpox. NV-387 for the treatment of Smallpox is expected to be eligible for an "Orphan drug" designation by the US FDA.”
NNVC could breakout higher.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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