NanoViricides, Inc. (NYSE American: NNVC) announced in its quarterly report for the period ended March 31, 2026, that its lead drug candidate NV-387 is advancing toward Phase II clinical development for MPox in the Democratic Republic of Congo, where regulatory approval for the trial has already been obtained. The company also highlighted progress in its orphan-first regulatory strategy, including FDA orphan drug designation for measles granted after the quarter, with additional applications targeting MPox and smallpox.
The development underscores NanoViricides' focus on broad-spectrum antiviral therapy. NV-387 is designed to treat multiple viral infections, including RSV, COVID-19, Long COVID, influenza, MPox, smallpox, and measles. The company believes its nanoviricide technology, based on proprietary nanomaterials, offers a novel approach to antiviral treatment by targeting viruses directly.
According to the press release, NanoViricides has obtained FDA orphan drug designation for measles, and it has submitted applications for MPox and smallpox. The orphan drug designation provides incentives such as tax credits and market exclusivity, which could accelerate development. The company's strategy aims to address unmet medical needs in diseases where treatment options are limited.
The quarterly report also noted that NanoViricides is preparing for Phase II trials for NV-387 in MPox. The Democratic Republic of Congo has been affected by MPox outbreaks, and the company's regulatory approval there marks a significant step. The company plans to leverage this trial to gather data that could support further clinical development for other viral indications.
NanoViricides' progress comes as the global health community continues to monitor viral threats. The broad-spectrum nature of NV-387 positions it as a potential candidate for pandemic preparedness. The company's pipeline includes other candidates such as NV-HHV-1 for shingles and formulations for COVID-19, including NV-CoV-2 and NV-CoV-2-R, which encapsulates remdesivir.
For more details, the full press release is available at https://ibn.fm/osO0q. Updates on NanoViricides can be found in the company's newsroom at https://ibn.fm/NNVC.
NanoViricides is a clinical-stage company focused on creating special purpose nanomaterials for antiviral therapy. Its technology is based on intellectual property licensed from TheraCour Pharma, Inc. The company's business model involves licensing technology for specific viral applications. As with any drug development, there is no assurance that NV-387 or other candidates will prove safe and effective in clinical trials or receive regulatory approval.
