NanoViricides, Inc. (NYSE American: NNVC) announced in its quarterly report for the period ended March 31, 2026, that it is advancing its broad-spectrum antiviral candidate NV-387 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 outlined progress in its orphan-first regulatory strategy, including FDA orphan drug designation for measles granted subsequent to the quarter and additional applications targeting MPox and smallpox.
NV-387 is the company's lead drug candidate, designed as a broad-spectrum antiviral to treat respiratory syncytial virus (RSV), COVID-19, Long COVID, influenza, and other respiratory viral infections, as well as MPox/smallpox infections and measles. The company also has NV-HHV-1 in development for shingles. According to the press release, NanoViricides believes that since remdesivir is already FDA approved, its drug candidate NV-CoV-2-R, which encapsulates remdesivir, is likely to be an approvable drug if safety is comparable.
The company's platform technology is based on TheraCour nanomedicine technology, licensed from TheraCour Pharma, Inc. NanoViricides holds a worldwide exclusive perpetual license for several drugs targeting HIV/AIDS, hepatitis B and C, rabies, herpes simplex, varicella-zoster, influenza, dengue, Japanese encephalitis, West Nile virus, Ebola/Marburg, and certain coronaviruses. The company intends to obtain licenses for RSV, poxviruses, and enteroviruses if initial research is successful.
The advancement of NV-387 into Phase II trials for MPox is significant given the ongoing global health concerns around MPox outbreaks. The orphan drug designation for measles could provide incentives for development, including tax credits and market exclusivity. The company's orphan-first strategy aims to expedite approvals for drugs targeting rare diseases, potentially accelerating patient access. However, the company cautions that drug development is lengthy and requires substantial capital, and there is no assurance that any candidate will show sufficient effectiveness and safety for human clinical development or become a successful product.
For more information, visit the company's newsroom at https://ibn.fm/NNVC and the full press release at https://ibn.fm/osO0q.
