NanoViricides(US:NNVC) Proactiveinvestors NA·2026-02-21 16:06Core Viewpoint - NanoViricides is advancing its broad-spectrum antiviral candidate NV-387, focusing on Mpox clinical development and confirming orphan drug designation filings for multiple indications [1] Company Progress - The company has completed the full clinical trial application to initiate a Phase 2 study of NV-387 in the Democratic Republic of Congo for Mpox, with import permissions secured [2][6] - The Phase 2 study is fully funded, with approximately $5.5 million raised in November and a quarterly spend of about $1.8 million [3][7] Market Context - Despite the WHO lifting the global Public Health Emergency declaration, Mpox cases continue to rise in parts of Africa, indicating a persistent need for development [3][5] - The focus on Mpox was chosen due to its shorter development pathway compared to other diseases like RSV and influenza, which require longer trials [8] Orphan Drug Designation - The company is filing for orphan drug designation for NV-387, which could lead to quicker regulatory approvals and significant benefits such as R&D tax credits and marketing exclusivity [9][11] - Orphan drug designation applications are typically processed within three to four months, and if granted, could allow for accelerated approval after Phase 2 trials [11][12] Potential Market Impact - The drug targets significant markets, including smallpox, Mpox, and measles, with rising measles cases in the US highlighting the need for effective treatments [10]