NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company developing special purpose nanomaterials for antiviral therapy, announced positive results from a juvenile mouse study evaluating the safety, tolerability, and toxicity of its broad-spectrum antiviral drug NV-387, according to a press release issued by MissionIR. The 12-day repeated-dose study found that NV-387 Oral Gummies were well tolerated at all tested dose levels, with no mortality, systemic toxicity, or treatment-related adverse effects observed.
The highest tested dose of 3,690 mg/kg/day was established as the No Observed Adverse Effect Level (NOAEL), and no maximum tolerated dose was identified. The company believes these findings could support pediatric enrollment in future clinical trials for Ebola, Mpox, and measles, subject to further clinical development and regulatory requirements. This safety profile is particularly important because NV-387 is being developed as a broad-spectrum antiviral with potential applications across multiple viral diseases.
NV-387 is currently being evaluated in Phase II clinical trials for Ebola and Mpox in the Democratic Republic of Congo. The drug has also received U.S. Food and Drug Administration orphan drug and rare pediatric disease designations for measles, underscoring its potential to address serious unmet medical needs. The positive juvenile safety data may facilitate the inclusion of pediatric populations in future trials, expanding the drug's potential market and therapeutic reach.
Separately, NanoViricides disclosed that its fiscal 2026 annual report included an auditor statement expressing substantial doubt about its ability to continue as a going concern. The company is pursuing potential nondilutive funding for clinical development while maintaining access to equity-based financing, including an at-the-market share offering facility. This financial disclosure highlights the capital-intensive nature of drug development and the risks faced by clinical-stage biotechnology companies.
For investors seeking more information, the full press release is available at https://ibn.fm/5QClt, and the latest news and updates relating to NNVC can be found in the company's newsroom at https://ibn.fm/NNVC. NanoViricides' website is www.nanoviricides.com.
The company's lead drug candidate, NV-387, is a broad-spectrum antiviral being developed for RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox and measles. NanoViricides' business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses. The company's novel nanoviricide class of drug candidates is based on intellectual property, technology, and proprietary know-how of TheraCour Pharma.
The positive juvenile safety results for NV-387 represent a significant step forward in the drug's development, potentially enabling pediatric trials for several high-priority viral diseases. However, the company's going concern doubt serves as a reminder of the financial challenges inherent in bringing new antiviral therapies to market. As NanoViricides continues to advance NV-387 through clinical development, the availability of funding will be critical to its success.
MissionIR is a specialized communications platform with a focus on assisting IR firms with syndicated content to enhance the visibility of private and public companies within the investment community. It is one of 75+ brands within the Dynamic Brand Portfolio @ IBN that delivers access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics, and diverse industries. For more information, please visit www.MissionIR.com. Please see full terms of use and disclaimers on the MissionIR website applicable to all content provided by MIR, wherever published or re-published: https://www.MissionIR.com/Disclaimer.
