Curated News
By: NewsRamp Editorial Staff
February 12, 2026

NanoViricides Seeks FDA Orphan Drug Status for MPox Treatment NV-387

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TLDR

  • NanoViricides seeks FDA orphan drug designation for NV-387 against MPox, potentially gaining tax credits, fee exemptions, and seven years of market exclusivity if approved.
  • NanoViricides filed an application with the FDA's Office of Orphan Products Development for NV-387 as an MPox treatment, citing limited therapeutic options and viral mutations.
  • NV-387 could address global MPox concerns by providing an effective therapeutic solution, improving public health outcomes and reducing reliance on limited existing treatments.
  • NanoViricides is developing NV-387 as a broad-spectrum antiviral using nanoviricide technology, targeting multiple viruses including MPox, RSV, COVID, and influenza.

Impact - Why it Matters

This news matters because it addresses a pressing global health issue: MPox, which continues to spread with limited therapeutic options and viral mutations. If granted Orphan Drug Designation, NV-387 could accelerate development through incentives like tax credits and market exclusivity, potentially leading to a more effective treatment compared to existing antivirals like TPOXX. For patients, this means hope for better outcomes, while for investors and the biotech sector, it highlights innovation in nanomedicine and the ongoing need for antiviral solutions amid persistent infectious disease threats.

Summary

NanoViricides, Inc. (NYSE American: NNVC), a clinical-stage biotechnology company, has taken a significant step in addressing global MPox concerns by filing an application for Orphan Drug Designation with the U.S. FDA Office of Orphan Products Development for its lead drug candidate, NV-387. This designation, if granted, would provide crucial incentives such as tax credits for clinical trials, exemption from certain user fees, and potential seven years of market exclusivity post-approval, positioning NV-387 as a promising therapeutic solution amid limited options like TPOXX(R) and TEMBEXA(R) and ongoing viral mutations. The company, which operates under a business model licensing technology from TheraCour Pharma, Inc., is focused on developing broad-spectrum antiviral nanomaterials, with NV-387 targeted for respiratory viral infections including RSV, COVID, Long COVID, Influenza, and MPOX/Smallpox, while also advancing other candidates like NV-HHV-1 for Shingles.

As part of the InvestorBrandNetwork, this news highlights NanoViricides' strategic move to leverage its nanoviricide(TM) technology, based on intellectual property from TheraCour, to tackle a range of viral diseases. The company's platform includes exclusive licenses for diseases such as HIV/AIDS, Hepatitis B and C, Rabies, and Influenza, with plans to expand to RSV, Poxviruses, and Enteroviruses upon successful research. However, it acknowledges the lengthy and capital-intensive nature of drug development, with no guarantees of success in clinical trials. For more details, readers can view the full press release via the provided hyperlink, which underscores the importance of this development in the biomedical and life sciences sectors, where BioMedWire serves as a key communications platform within the Dynamic Brand Portfolio.

The announcement emphasizes the ongoing need for effective antiviral therapies, particularly as MPox continues to pose global health challenges with evolving strains. NanoViricides' approach, rooted in innovative nanomedicine, aims to fill gaps left by existing treatments, offering hope for improved patient outcomes. Investors and stakeholders can stay updated through the company's newsroom, accessible via the hyperlink, as this filing marks a critical milestone in the biotech industry's fight against infectious diseases, driven by cutting-edge research and strategic partnerships.

Source Statement

This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, NanoViricides Seeks FDA Orphan Drug Status for MPox Treatment NV-387

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