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NanoViricides Has Signed a Master Services Agreement with OnlyOrphansCote Regarding Orphan Drug Strategy of NV-387 for Treatment of MPox, Smallpox, and Measles
SHELTON, CONNECTICUT / ACCESS Newswire / December 1, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic ...
About this update from Nanoviricides, Inc.
[{"type":"text","content":"SHELTON, CONNECTICUT / ACCESS Newswire / December 1, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.: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 signed a Master Services Agreement (MSA) with Only Orphans Cote, LLC, ("OOC") a regulatory consultant firm founded by Dr. Timothy Cote. Dr. Cote and OOC will help the Company formulate its orphan drug strategy for NV-387, as well as develop relevant orphan drug designation applications and prosecute these applications at the US FDA Office of Orphan Products.","length":717,"tagName":"p"},{"type":"text","content":""In earlier discussions with Dr. Cote, it became apparent that the broad-spectrum antiviral drug NV-387 could harness several benefits from an orphan drug regulatory strategy," said Anil R. Diwan, PhD, President & Executive Chairman of the Company.","length":262,"tagName":"p"},{"type":"text","content":"NV-387 has demonstrated excellent activity against lethal animal models of orthopoxvirus ectromelia infections in mice. This opens up the regulatory pathway for licensure of NV-387 for the treatment of Smallpox. NV-387 for the treatment of Smallpox is expected to be eligible for an "Orphan drug" designation by the US FDA. Smallpox, eradicated globally in 1980, is considered an important bioterrorism threat.","length":420,"tagName":"p"},{"type":"text","content":"Additionally, MPox disease caused by the Monkeypox virus, MPXV, a related orthopoxvirus, is considered an "orphan disease" in the USA. Therefore, we believe that NV-387 for the treatment for MPox will be eligible for orphan drug designation.","length":251,"tagName":"p"},{"type":"text","content":"Further, NV-387 is the only drug candidate to our knowledge that has demonstrated in vivo activity against the Measles virus in a humanized animal model study. Measles infection in the USA is considered an "orphan disease" due to the small number of cases. Therefore, we believe that NV-387 for the treatment for Measles will be eligible for orphan drug designation.","length":376,"tagName":"p"},{"type":"text","content":"Orphan drug designation qualifies sponsors for incentives includ...