Curated News
By: NewsRamp Editorial Staff
December 01, 2025
NanoViricides Partners with OOC for Orphan Drug Strategy on NV-387
TLDR
- NanoViricides' orphan drug strategy for NV-387 could secure tax credits, fee exemptions, and up to seven years of market exclusivity, offering a significant competitive advantage.
- NanoViricides signed an agreement with Only Orphans Cote to develop an orphan drug strategy and prepare FDA applications for NV-387, which targets orthopoxvirus infections.
- NV-387's potential orphan designations for Smallpox, MPox, and Measles could lead to new treatments for rare viral diseases, improving global health outcomes.
- NanoViricides uses host-mimetic nanomedicine to create broad-spectrum antivirals, with NV-387 showing strong activity in lethal animal models of orthopoxvirus infections.
Impact - Why it Matters
This development matters because orphan drug designations can expedite the availability of treatments for rare diseases like Smallpox and MPox, which often lack effective therapies. By pursuing this status, NanoViricides aims to leverage regulatory incentives to accelerate NV-387's development, potentially offering a new tool against viral threats that pose public health risks. For patients, this could mean faster access to innovative antivirals, while investors may see reduced development costs and enhanced market potential. In a world grappling with emerging viruses, advancing broad-spectrum antivirals like NV-387 is crucial for pandemic preparedness and treating neglected infections.
Summary
NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage company pioneering broad-spectrum antivirals using host-mimetic nanomedicine, has taken a significant step toward developing its lead drug candidate, NV-387. The company signed a Master Services Agreement with regulatory consultant Only Orphans Cote (OOC), founded by Dr. Timothy Cote, to help craft an orphan drug strategy and prepare applications for orphan drug designation at the US FDA Office of Orphan Products. This strategic move targets potential designations for NV-387 against Smallpox, MPox, and Measles, supported by the drug's demonstrated strong activity in lethal animal models of orthopoxvirus infections. Securing orphan drug status could provide NanoViricides with valuable incentives, including tax credits, user-fee exemptions, and up to seven years of market exclusivity, accelerating the drug's path to patients with rare viral diseases.
The company's innovative platform is built on the nanoviricide™ technology licensed from TheraCour Pharma, Inc., focusing on creating special-purpose nanomaterials for antiviral therapy. NV-387 is positioned as a broad-spectrum antiviral intended to treat a range of conditions, including RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, alongside MPOX/Smallpox. With plans to advance NV-387 into Phase II human clinical trials, NanoViricides is also developing other candidates like NV-HHV-1 for Shingles and exploring treatments for diseases such as Herpes, HIV, and Ebola. The company's extensive licensing agreements cover numerous viral targets, underscoring its ambitious pipeline, though it acknowledges the inherent risks and lengthy timelines typical of drug development.
This news is part of a broader communication effort facilitated by InvestorWire, a specialized platform within the Dynamic Brand Portfolio @ IBN, which enhances press release syndication and social media distribution to reach investors and the public effectively. For more details, readers can view the full press release via the provided link, and updates on NNVC are available in the company's newsroom. This partnership highlights NanoViricides' proactive approach to navigating regulatory pathways, potentially bringing novel antiviral solutions to market faster for underserved patient populations.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, NanoViricides Partners with OOC for Orphan Drug Strategy on NV-387
