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NanoViricides Advances NV-387 into Phase II Trials for Mpox and Ebola, Receives FDA Designations for Measles

By Burstable Health Team•
NanoViricides reports fiscal 2026 progress with NV-387, including Phase II approvals in the DRC for Mpox and Ebola and FDA designations for measles, signaling potential for a broad-spectrum antiviral.
NanoViricides Advances NV-387 into Phase II Trials for Mpox and Ebola, Receives FDA Designations for Measles

NanoViricides, Inc. (NYSE American: NNVC) reported financial results for its fiscal year ended June 30, 2026, and provided an update on its clinical and regulatory progress for its lead antiviral candidate, NV-387. The company received regulatory approval in the Democratic Republic of Congo to initiate Phase II trials evaluating NV-387 Oral Gummies for the treatment of Mpox and Ebola. Both trials began enrolling patients at the end of September 2026, marking a significant step forward for a broad-spectrum antiviral that could address multiple high-consequence infectious diseases.

In addition to the international trial approvals, NanoViricides received two key designations from the U.S. Food and Drug Administration for NV-387 as a treatment for measles: Orphan Drug Designation and Rare Pediatric Disease Drug designation. These designations are designed to incentivize the development of therapies for rare diseases and may provide benefits such as tax credits, user fee waivers, and potential market exclusivity. The Rare Pediatric Disease designation also makes the company eligible for a priority review voucher upon approval, which can be sold or transferred.

Financially, NanoViricides reported approximately $2.79 million in cash and cash equivalents as of June 30, 2026, up from approximately $1.67 million a year earlier. During fiscal 2026, the company raised approximately $9.01 million through registered direct and at-the-market equity offerings. In July, the company raised an additional approximately $3.8 million and stated it is pursuing further funding through grants, contracts, partnerships, and debt or equity financing to support its ongoing clinical programs.

NanoViricides is a clinical-stage company creating special purpose nanomaterials for antiviral therapy. Its novel nanoviricide class of drug candidates is based on intellectual property licensed from TheraCour Pharma, Inc. The company's lead candidate, NV-387, is being developed as a treatment for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections and measles. Another advanced candidate, NV-HHV-1, is in development for the treatment of Shingles. For more information, the full press release is available at https://ibn.fm/s000r, and the company's website is www.nanoviricides.com.

The implications of these developments are significant for both public health and the antiviral drug market. If successful, NV-387 could become a much-needed broad-spectrum antiviral, offering a single therapy that targets multiple viruses. This is particularly important for emerging infectious diseases like Mpox and Ebola, where outbreaks can be unpredictable and existing treatments are limited. The Phase II trials in the DRC will provide critical data on the safety and efficacy of NV-387 Oral Gummies, a formulation that could be easier to administer in resource-limited settings.

For investors, the progress of NV-387 and the additional funding demonstrate the company's ability to advance its pipeline despite the lengthy and capital-intensive nature of drug development. However, as with any clinical-stage biotech, there are substantial risks. The company notes that there can be no assurance that its drug candidates will show sufficient effectiveness and safety for human clinical development. The path to regulatory approval remains uncertain and dependent on successful trial outcomes.

NanoViricides' latest news and updates are available in its newsroom at https://ibn.fm/NNVC. The company's progress is being closely monitored by investors and industry analysts, as it could signal a new era in antiviral therapy. MissionIR, a specialized communications platform, provides syndicated content to enhance visibility for companies like NanoViricides. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers access to a vast network of wire solutions via InvestorWire, among other services. For more information, visit MissionIR. Please see full terms of use and disclaimers on the MissionIR website at https://www.MissionIR.com/Disclaimer.

Burstable Health Team

Burstable Health Team

@burstable

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