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Hello!
New Alert: NanoViricides, Inc. (NYSE American: NNVC)
NNVC is our new NYSE American biotech alert.
NNVC is trading under 2.00 - and it is advancing what could be one of the most timely drug candidates in the biotech space today.
NNVC has delivered multiple big wins, with previous breakouts reaching gains of +35%, +53%, +44% & +25%!
Following our alert in May, NNVC rallied upwards of +55%!
Since then, we have been monitoring NNVC closely for its next breakout moment.
After building a base for the past few weeks, we believe NNVC could be positioned for a big rally higher.
In addition, just this morning the company announced big breaking news that could be a big growth catalyst.
NNVC is a NYSE American listed “clinical stage company that is creating special purpose nanomaterials for antiviral therapy”.
NNVC is a “leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape”.
Most antiviral drugs work by attacking a specific part of a specific virus.
The problem: viruses mutate. And when they do, the drug stops working.
NNVC took a fundamentally different approach.
NNVC’s “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, and even Measles.”
“NV-387 is a revolutionary antiviral that we believe will be the drug offered at “ first visit” when the patient presents to a doctor with any respiratory viral illness.”
Viruses cannot escape NV-387 because no matter how much a virus changes, it continues to bind to the sulfated proteoglycan attachment receptor(s) of the host which the virus needs to cause infection as well as for human-to-human transmission.
NV-387 mimics the critical features of the conserved attachment receptors on the host-side that over 90% of viruses are known to use.
This escape-resistant drug feature of NV-387 solves the biggest problem in antiviral medical countermeasures: Viruses readily evolve to escape the countermeasures in the field, whether vaccines, antibodies, or traditional small chemical drugs.
NV-387 has an extremely broad spectrum of antiviral activity.
“To date, it has been found to be highly active against every virus that we have tested in animal models:
NV-387 treatment was found to be able to cure lethal RSV infection in mice.
NV-387 treatment was substantially superior to the existing treatments, namely Tamiflu (oseltamivir) and Xofluza (baloxavir) in a lethal infection with H3N2 Influenza A virus.
NV-387 treatment was highly effective in an animal model for MPox using dermal orthopoxvirus infection.
NV-387 treatment was highly effective in an animal model for Smallpox using lethal lung infection with orthopoxvirus.
In addition, NV-387 treatment was highly effective in a humanized animal model (hSLAM+k.i., InfAR-/- mice) in lethal infection with Measles virus.
Thus, NV-387, as a single drug, is responding to several unmet medical needs in viral infectious diseases at once.”
The company has “filed "Orphan Drug Designation" (ODD) applications with the US FDA for three different scenarios, namely:
NV-387 for the treatment of Measles,
NV-387 for the treatment of MPox, and
NV-387 for the treatment of Smallpox.”
“Orphan drug designation, if approved, will provide us with several incentives.”
“These include frequent communication with the FDA, an additional 7 years of market exclusivity, certain R&D tax benefits, and waiver of certain FDA PDUFA fees.”
“These incentives are expected to result in a shorter timeline of the regulatory process as compared to NV-387 development for Influenza or RSV.”
Sadly, at present:
“There is no approved drug for Measles.
There is no approved drug for MPox.
The Smallpox approved drugs (under FDA Animal Rule) have significant shortcomings, leaving the US practically unprepared for this bioterrorism scenario despite several billions of dollars in development and acquisitions.”
NNVC also “applied for a "Rare Pediatric Disease Drug" (RPDD) designation for NV-387 for the treatment of Measles.”
As the company further explains:
“If granted, the RRPD will enable us to obtain a Priority Review Voucher (PRV) upon drug approval from the FDA, which is a tradable instrument. Recently, a PRV was sold for $180 million.”
“This would represent a revenue-generation opportunity even prior to commercial market sales of the drug.”
The commercial opportunity the company is targeting is substantial.
“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.”
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”.
“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.”
The company has announced multiple developments recently.
On May 4, 2026, the company announced:
“NV-387 for The Treatment of Measles is Granted Orphan Drug Designation by The US FDA”
Here are the company’s comments from this press release:
"The Orphan Drug Designation is an important milestone that will help us speed up the regulatory development of NV-387 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."
Importantly:
“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.”
Sadly:
“Measles cases have been rising globally. This year, a major epidemic has broken out in Bangladesh with over 227 children dead and over 35,000 cases, while Guatemala has an on-going Measles outbreak with over 5,300 cases and four deaths[2].”
“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 years[3].
Measles cases have been rising in the USA. As of April 30, 2026, already 1,803 confirmed measles cases (excluding 11 in international travelers) were reported in the United States in 2026. in the year 2025, 2,251 confirmed cases with 3 deaths were reported, increasing from 285 in 2024 and 59 in 2023 (no deaths in these prior years). Vaccine breakthrough accounted for 6-7% of cases, with the remaining cases being in unvaccinated or persons with unknown vaccine status. (CDC data[4]).
Measles continues to be a rare disease in the USA, with annual incidence rates well below 200,000 cases, which has qualified NV-387 for Measles Treatment as an Orphan Drug indication.”
In June, the company announced:
“As the Ebola Emergency Outbreak Grows Rapidly, NanoViricides Has Proposed a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment - with Superior Oral Administration and Escape Resistance Features Over Antibodies”
“The outbreak which was declared a Public Health Emergency of International Concern ("PHEIC") by the WHO on May 17, 2026, continues to rapidly expand, outpacing containment efforts. The WHO has revised the number of confirmed cases to 452 and deaths to 82 in DRC plus 19 confirmed cases and 2 deaths in neighboring Uganda[2]. These are the latest numbers after the WHO had previously reported 906 suspected cases and 220 suspected deaths in DRC; the latter numbers have been revised after expanded testing. The outbreak arose in a high traffic region bordering the Democratic Republic of Congo (DRC), with travel contacts to Uganda, and South Sudan and with 11 more nations in Africa at risk[3].”
As the company further explains:
“A new antibody cocktail, MBP134 (ZMapp), a monoclonal antibody, Maftivimab (Regeneron), and a nucleotide analog Remdesivir are being considered for treatment.”
“All of these potential treatments require I.V. infusions with most requiring multiple infusions. This is very difficult to implement in the low resource environment, complicated with the lethal disease scenario of extreme isolation suites, and healthcare workers covered with PPE. Further, monoclonal antibodies are highly specific to the strain of virus and usually are not effective against unrelated strains.”
“Infusions are certainly not scalable in a large outbreak scenario if this Ebola virus outbreak continues to grow, as has been widely expected.”
Further, “viruses readily escape antibodies after exposure to the drugs”.
In contrast, “NV-387 Oral Gummies is a drug product readily delivered orally. It does not even require swallowing effort or water, because it dissolves in the mouth by itself, simplifying delivery for even sick individuals with swallowing difficulties.
This oral delivery is an important feature that puts NV-387, a broad-spectrum antiviral, as being superior to the other approaches.”
Here are some of the comments:
"We believe NV-387 could be effective against the Bundibugyo strain of Ebola that is spreading rapidly in Africa," said Anil R. Diwan, PhD, adding, "It is an oral drug, in contrast to other infusions, which makes for easy scalability of NV-387 treatment in this lethal disease theater to treat the most number of patients while requiring the least amount of healthcare resources. Thus evaluating if NV-387 treatment works is of paramount importance to combat this outbreak."
In addition, the company also announced:
“As the Ebola Epidemic Spreads, NV-387 Oral Gummies Can Enter a Phase II Clinical Trial for Treatment of Ebola - NanoViricides Proposal is Approved by the Pillar Committee in DR Congo”
“There is no approved treatment or vaccine for the new variant of the Bundibugyo Ebolavirus (BDBV) that is causing the current rapidly expanding outbreak of the Ebolavirus Disease (EVD) in DR Congo and Uganda. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source[1], such as fruit bats.”
Importantly:
“NV-387 is the only orally active agent under consideration for clinical trial as a treatment of Ebola to the best of our knowledge. In an epidemic scenario in resource limited settings such as in DRC, oral drug is a highly advantageous feature.”
Furthermore:
“NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for the Phase II Mpox clinical trial in DRC previously. Om Sai CRO has been instrumental in the successful submission, in a rapid timeframe, of our proposal to the Pillar Committee for the Phase II Clinical Trial for Evaluation of NV-387 Oral Gummies as a Treatment of Ebola Viruses in DRC.”
“The next steps for NanoViricides will be to perform appropriate submissions to the National Ethics Committee of DRC, and upon their approval, to submit a clinical trial application to the regulatory agency, ACOREP for approval to begin the clinical trial. Most of these documents are ready because the same drug NV-387 Oral Gummies has been approved by ACOREP for a Phase II clinical trial as a Treatment for Mpox in DRC.”
Most recently, last week, the company announced:
“NanoViricides Has Shipped NV-387 Oral Gummies Drug Product for Phase II Clinical Trial to DR Congo”
“Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt. Ltd., and associates in DRC. The CRO personnel have visited the site several times, despite travel restrictions, and changing flight schedules and cancellations, as required for the preparations. Enrollment and dosing of patients is expected to begin after the staff training is completed in a few weeks.”
“This Phase II clinical trial was previously delayed because of change in the clinical trial site away from Kinshasa. An on-site examination of the new site by our CRO found that the new site required substantial amount of preparation in readiness for conducting the clinical trial. Our preparations experienced additional delays after the travel restrictions within DRC and internationally were imposed subsequent to the May 17 declaration of a Public Health Emergency of International Concern (PHEIC) due to an Ebola outbreak in DRC.”
Here are some of the company’s comments from this press release:
"NV-387, our broad-spectrum antiviral drug is poised to cause a revolution in treatment of viral diseases, just as antibiotics revolutionized the treatment of bacterial diseases," said Anil R. Diwan, Ph.D., adding "NV-387 is designed to mimic human cells to trap and destroy the virus. This single drug can target over 90-95% of human pathogenic viruses due to this biomimicry, which is reminiscent of the antibiotic penicillin that targets a large number of human pathogenic bacteria."
In addition, just this morning the company announced big breaking news:
“US FDA Has Granted A "Rare Pediatric Disease Drug" Designation for NV-387 As A Treatment for Measles - Enables Priority Review Voucher”
“SHELTON, CT / ACCESS Newswire / June 29, 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 its clinical stage, broad-spectrum, antiviral drug NV-387 has been granted a "Rare Pediatric Disease Drug" (RPDD) Designation by the US FDA Office of Orphan Products Development (OOPD).”
Importantly:
“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 $195 Million1.”
Furthermore:
“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 now granted both ODD and RPDD for NV-387 as a Treatment of Measles.”
NNVC could be positioned to breakout higher.
Make sure to do your own due diligence.
Happy Trading!
SmallCapStocks Team
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