MPox Orphan Drug Designation Application Filed for NV-387, Declares NanoViricides

SHELTON, CONNECTICUT / ACCESS Newswire / February 12, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for Orphan Drug Designation (ODD) for "NV-387 as a Treatment for MPox" with the US FDA Office of Orphan Products Development (OOPD).

If approved, orphan drug designation will qualify NanoViricides for incentives including:

• Tax credits for qualified clinical trials;

• Exemption from certain user fees;

• Potential seven years of market exclusivity after approval;

according to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-condit ...).

"NV-387, as an effective drug would be an important tool to fight MPox in the USA and worldwide, when approved after clinical trials," said Anil R. Diwan, PhD, adding, "MPXV clade IIb is endemic in the USA. Further, the more contagious MPXV Clade Ia/Ib continues to simmer in Africa and is mutating, posing a potential global pandemic threat."

WHO had declared a "Public Health Emergency of International Concern" (PHEIC) for MPox in 2022 due to the spread of MPXV Clade II into Western countries, ending it about a year later. A new PHEIC was declared by WHO again in August, 2024, due to the spread of MPox Clade Ia/Ib in African region, ending it in September, 2025. However, the Africa CDC has continued the declaration of the MPox pandemic in African Region as Public Health Emergency of Continental Security ("PHECS"), due to continued spread of the MPXV virus.

MPox disease is caused by infection with MPXV (Monkeypox Virus) virus. While earlier MPXV infections were related to zoonotic (i.e. from animals) transmission to humans, the virus has evolved to a highly contagious form, MPXV Clade Ib, in recent years with continuous human-to-human transmission. MPXV is closely related to Variola virus that causes Smallpox in humans. Smallpox is a far more severe and lethal disease compared to MPox. Smallpox was globally eradicated by 1980 by an aggressive vaccination campaign with an effective vaccine that provides lifelong immunity. This success is founded in the fact that Smallpox is restricted to humans and has no animal reservoirs, unlike MPox which has many animal reservoirs. Smallpox continues to be a bio-terrorism concern.