Health
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 ...
About this update from Nanoviricides, Inc.
[{"type":"text","content":"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).","length":514,"tagName":"p"},{"type":"text","content":"If approved, orphan drug designation will qualify NanoViricides for incentives including:","length":89,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Tax credits for qualified clinical trials;","length":42,"tagName":"p"}]},{"val":[{"type":"text","content":"Exemption from certain user fees;","length":33,"tagName":"p"}]},{"val":[{"type":"text","content":"Potential seven years of market exclusivity after approval;","length":59,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":134,"olType":false},{"type":"text","content":"according to the US FDA (https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/designating-orphan-product-drugs-and-biological-products).","length":158,"tagName":"p"},{"type":"text","content":""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."","length":363,"tagName":"p"},{"type":"text","content":"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.","length":543,"tagName":"p"},{"type":"text","content":"MPox d...