NanoViricides Awaits Approval from DR Congo Regulatory Agency for a Phase II Clinical Trial of NV-387 Oral Gummies as a Treatment for Ebola, Financing Completed to Support the Trial
Rhea-AI Summary
NanoViricides (NYSE American: NNVC) reported that it is awaiting regulatory approval from the DR Congo agency ACOREP for a Phase II clinical trial of NV-387 oral gummies as a treatment for the current Bundibugyo ebolavirus outbreak. The company stated it has already completed financing that it believes is sufficient to cover the additional expenses of this anticipated trial.
According to NanoViricides, NV-387 is a broad-spectrum antiviral and, to its knowledge, the only orally active Ebola treatment candidate currently under consideration for clinical testing. A contract research organization, Om Sai Clinical Research, and a local principal investigator in the affected region have submitted the trial application, and drug product supply is already in DRC. Om Sai is also leading a Phase II trial of NV-387 oral gummies for Mpox in DRC, positioning logistics and infrastructure that may support the proposed Ebola study.
Positive
- Financing completed to support Ebola Phase II; company says it covers additional trial expenses
- Phase II Ebola trial application submitted to ACOREP in DR Congo
- CRO Om Sai and local PI engaged to lead the proposed Ebola trial
- NV-387 oral gummies drug supply already positioned in DR Congo for trial use
- NV-387 in Phase II for Mpox in DRC, leveraging existing infrastructure for Ebola program
Negative
- Regulatory approval from ACOREP for the NV-387 Ebola Phase II trial is still pending
News Explained
As a liquidity reference, NanoViricides reported
Sources and calculations
- NanoViricides press release (2026-07-28)
- NanoViricides latest-quarter fundamentals (2026Q3)
- Cash and equivalents vs quarterly operating cash outflow, in days of cash use $3,213,256 / ($1,930,582 / 90) = [object Object]
Market reaction after Phase II Ebola trial application: NNVC +5.19%
Following this news, NNVC has gained 5.19%, reflecting a notable positive market reaction. Our momentum scanner has triggered 5 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $1.62.
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Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jul 22 | Ebola trial application | Positive | -5.0% | Applied to ACOREP for Phase II Ebola trial approval; shares declined 5% |
| Jul 13 | Ethics approval | Positive | +9.3% | National Ethics Committee approved planned Phase II Ebola trial; shares rose 9.27% |
| Jul 06 | Trial development progress | Positive | +12.8% | Pillar Committee approved Ebola trial proposal; shares rose 12.78% |
| Jun 22 | Drug product shipment | Positive | -5.7% | Shipped NV-387 gummies to DRC for Phase II trial; shares declined 5.71% |
| Jun 15 | Trial proposal approval | Positive | +15.6% | DRC Pillar Committee approved Phase II Ebola trial proposal; shares rose 15.57% |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific clinical-trial announcements produced three aligned positive reactions and two divergences, including a negative reaction to the July 22 application update.
Key Terms
HSPG medical
NPC1 medical
PHEIC regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
SHELTON, CT / ACCESS Newswire / July 28, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical stage leader developing antiviral drugs that viruses cannot escape, announces that it is eagerly awaiting regulatory approval to begin a Phase II Clinical Trial of NV-387 Oral Gummies, after having filed an application to the local regulatory agency ACOREP, as a Treatment for the Current Bundibugyo Ebolavirus in the Democratic Republic of Congo (DRC). The Company explains that it has already raised the financing to support this clinical trial.
"The financing we closed yesterday is sufficient to support the additional expenses from the anticipated Ebola clinical trial of NV-387 Oral Gummies," said Anil R, Diwan, PhD, adding, "This rapidly growing Ebola outbreak requires a new orally acting drug to help patients and to control further spread from infected persons. Infusion drugs are simply not up to the task, as is well known."
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, we believe an oral drug is a highly advantageous feature.
Other treatments require infusions. Infusions are difficult to implement and also are not scalable in a large outbreak scenario, such as this Ebola virus outbreak if it continues to grow, as has been widely expected.
A clinical trial of Remdesivir infusion, an antibody cocktail MBP134 infusion, and MBP134 infusion plus Remdesivir infusion, has started according to the WHO, with first patient having received infusion of the antibody cocktail on July 2, 2026 1.
"Although this antiviral (Remdesivir) proved to be ineffective at targeting the Zaire Ebolavirus, there remains hope that it could have some benefit against the Bundibugyo virus, particularly if used in combination with MBP-134," according to an article in Forbes explaining the "PARTNERS" clinical trial by the WHO organized collaboration 2. The article also notes that MBP134 contains two separate antibodies designed to, taken together, recognize multiple Ebola species.
Antibodies are highly specific to a particular strain of the virus and usually are not very effective against variants of the same virus that arise in the field.
The Company notes that NV-387 was previously found to be superior to Remdesivir in a lethal animal model of a viral disease. The Company believes this superiority of NV-387 is reasonably expected to extend to the current novel Bundibugyo ebolavirus strain.
The death toll has already risen above 1,300, with close to 3,000 confirmed cases, rising by more than
There is thus a tremendous urgency to validate a drug that works against this ebolavirus in short and decisive clinical trials for minimizing further spread by treating patients and for saving lives. NanoViricides CRO, in consultation with renowned scientists in DRC, has designed the Phase II clinical trial with this particular objective.
In contrast, the PARTNERS clinical trial will require over 1,000 patients to be treated and may not yield results for at least more than a year. A similar large collaborative clinical trial effort in the West Africa outbreak resulted in US FDA approval of two antibody drugs only specifically for EBOV Zaire, which are not deemed to be useful in the current outbreak without further clinical trials.
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. The rare Bundibugyo strain of Ebola virus causing the current outbreak appears to be its new variant, likely freshly introduced from some animal source 6, such as fruit bats.
A new clinical trial of an Oxford University designed Bundibugyo-specific vaccine has also started in DRC (ibid, #2).
NanoViricides has retained Om Sai Clinical Research Private Limited, India, as the CRO for this Phase II clinical trial for Ebola in DRC. Om Sai CRO has been instrumental in putting together a team with a renowned Principal Investigator and other renowned experts and with support from a well known University in the Ebola-affected region to lead and execute the clinical trial of NV-387 Oral Gummies as a Treatment for Ebolaviruses in DRC. The Principal Investigator has sent in the application for the clinical trial.
Om Sai is also the CRO leading the Company's Phase II clinical trial of NV-387 Oral Gummies as a Treatment for Mpox in DRC.
"We believe NanoViricides is well positioned to provide an Oral Ebola treatment to save lives with our NV-387 Oral Gummies drug product that is already in place in DRC," said Anil R. Diwan, PhD, President of the Company, adding, "This unique and revolutionary oral broad-spectrum antiviral drug deserves to be tested in a clinical trial more than any antibodies or other infusion drugs." He further commented, "Viruses readily escape antibodies after exposure to them as we know from COVID-19. Infusions are not scalable to combat an outbreak of the size that is seen in DRC."
Sufficient quantity of NV-387 Oral Gummies Drug Product for starting the clinical trial against Ebola is already available in DRC. This drug product was shipped to DRC for the ensuing Phase II clinical trial of NV-387 for the Treatment of Mpox and also to support a Phase II clinical trial for the Treatment of Ebola if approved by the regulatory agency.
"We believe NV-387 could be revolutionary in this fight against Ebola, if it is found to be effective," said Anil R. Diwan, PhD, adding, "It is an oral drug, in contrast to other that are infusions. Thus evaluating if NV-387 treatment works is of paramount importance to combat this and future Ebola and Marburg outbreaks."
NV-387 is a broad-spectrum antiviral that mimics the host-side features that the virus requires, and is likely to be effective against Ebola viruses because they use the same host-side feature mimicked by NV-387. It is highly unlikely that viruses can escape NV-387, because this drug mimics the features on host cells that the viruses continue to require even as they mutate or evolve in the field.
Additionally, 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.
While there is currently minimal risk of Ebola in the USA, the CDC's mathematical models suggested this Central African outbreak could grow to 10,000 to 20,000 cases and 2,000 to 4,000 deaths within just three months, rivaling the largest outbreak to date in 2014-2016 7. Unfortunately, the outbreak appears to be on track to realize these dire predictions.
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 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 8.
NV-387 is a broad-spectrum antiviral that mimics the host-side feature called heparan sulfate proteoglycan that over 90
All Ebola viruses utilize HSPG as the attachment receptor, followed by entry into the cell inside endosomes. The virus substantially dismantles in the endosome and hitches a cognate receptor called NPC1 to enter the cytoplasm where the next steps in its replication begin.
Thus there is a strong rationale that NV-387 could be highly effective against Ebola virus infections, not just Bundibugyo, but also the Sudan and other viruses for which there are no treatments.
NV-387 is available as an oral medication that has excellent stability at room temperature, enabling ease of transport, distribution, and delivery to patient. NV-387 oral gummies dissolve naturally in the mouth and do not require tablet swallowing, which is difficult for children, seniors, and also patients with sore throat.
If NV-387, as a broad-spectrum antiviral, is found to be effective against the Bundibugyo virus, it will likely be effective against all ebolaviruses and possibly all filoviruses; that would be a game changer for pandemic preparedness.
All previous anti-Ebola efforts have been focused on vaccines and antibodies 9. This has led to approval of therapies that are specific to the Ebolavirus Zaire strain only, albeit with limited effectiveness. This leaves out all other filoviruses of consequence: Sudan, Marburg, and the more rare Bundibugyo with no treatment or vaccine.
The US Government is active in ensuring that suspected or confirmed ebolavirus cases do not enter the general population in the US. To this end, travel from DRC has been restricted, with pre-travel quarantine requirements imposed, and suspect travelers are directed to screening at specific airports and may be further quarantined.
The case fatality rate of ebolaviruses has generally been approximately
An irony is that because of the high case fatality rate (CFR) approaching
So far, BDBV has demonstrated variable CFR ranging from under
With ever-increasing global travel, local outbreaks such as ebola can quickly travel far and wide potentially causing global pandemics, as was the case with COVID-19, if not caught in time. It is not feasible to produce a new vaccine and a new set of antibody drugs to combat every possible virus. Even if vaccines and antibodies are produced, the virus would escape by generating variants, as the world has witnessed during the COVID-19 pandemic.
"Only safe and effective broad-spectrum antiviral drugs that can effectively combat most viral infections will enable the world to combat viruses and defend the global population in the war against known and unknown nanoscopic enemies that are viruses," commented Dr. Diwan, adding, "NV-387 is the only drug with such potential that is in clinical development today, to the best of our knowledge."
NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a 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.
NV-CoV-2 (API NV-387) is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-387 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently.
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.
9 Substantial work was also performed to develop small chemical potentially broad-spectrum agents. Remdesivir was the only small chemical that entered the PALM clinical trials ca. 2018-2019 but failed to show effectiveness. Small chemicals are readily escaped by viruses often with just single mutations.
SOURCE: NanoViricides
View the original press release on ACCESS Newswire