NanoViricides reports juvenile mouse safety data for NV‑387, clearing path for pediatric trials
NanoViricides announced that its antiviral candidate NV‑387 oral gummies were well tolerated in a 12‑day repeated‑dose study in juvenile mouse pups, with no mortality or treatment‑related adverse effects. The No Observed Adverse Effect Level was set at 3,690 mg/kg/day, the highest dose tested, and the study supports adding pediatric cohorts to future Phase III trials for Ebola and Mpox and pursuing measles trials, which have FDA orphan and rare‑pediatric disease designations. The company also disclosed that its FY 2026 audit report expressed substantial doubt about its ability to continue as a going concern.
Why it matters
The safety data could enable NV‑387 to seek pediatric indications, potentially expanding its market if later‑stage trials succeed (the company says). The going‑concern warning highlights financial risk for investors as the firm funds expensive clinical programs without a marketed product (the audit report states).
Key facts
- 1The juvenile mouse study determined a No Observed Adverse Effect Level of 1,230 mg/kg per dose, equivalent to 3,690 mg/kg/day, over a 12‑day dosing period. stocktitan.net
- 2Total cumulative drug exposure in the study was 44,280 mg/kg across the 12‑day period. stocktitan.net
- 3No mortality, systemic toxicity, or treatment‑related adverse effects were observed at any dose level. citybuzz.co
- 4NV‑387 has received U.S. FDA orphan drug and rare pediatric disease designations for measles. citybuzz.co
- 5The FY 2026 annual report included an auditor’s statement expressing substantial doubt about the company’s ability to continue as a going concern. citybuzz.co
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.