NanoViricides, Inc. (NYSE American: NNVC) announced in its quarterly report for the period ended March 31, 2026, that it has obtained regulatory approval to begin Phase II clinical development of its broad-spectrum antiviral candidate NV-387 for MPox in the Democratic Republic of Congo. The company also disclosed that subsequent to the quarter, the U.S. Food and Drug Administration granted orphan drug designation for NV-387 as a treatment for measles, and additional orphan drug applications are pending for MPox and smallpox.
This progress underscores the company's "orphan-first" regulatory strategy, which aims to expedite development through incentives such as market exclusivity and tax credits. NV-387 is a nanoviricide drug candidate designed to target multiple viral diseases, including respiratory syncytial virus (RSV), COVID-19, influenza, and poxviruses. The company believes that its broad-spectrum mechanism could address significant unmet medical needs, particularly in regions where viral outbreaks are common.
The quarterly report also highlighted NanoViricides’ ongoing efforts to advance NV-387 into Phase II human clinical trials. The company has a Memorandum of Understanding with TheraCour Pharma, Inc., which provides access to proprietary nanomedicine technology licensed from AllExcel. This technology forms the basis for NanoViricides' drug candidates, including NV-CoV-2 (API NV-387) for COVID-19 and NV-CoV-2-R, which encapsulates remdesivir.
NanoViricides is developing additional drug candidates for a range of viral diseases, including herpes simplex, HIV, hepatitis C, rabies, dengue, and Ebola. The company holds exclusive licenses for several antiviral applications and continues to expand its pipeline. However, it cautions that drug development is inherently risky and capital-intensive, and there is no assurance that any candidate will achieve clinical success or regulatory approval.
For more information on the company's latest developments, visit its newsroom at https://ibn.fm/NNVC. The full press release is available at https://ibn.fm/osO0q.
