NanoViricides says its broad-spectrum antiviral could help tackle Ebola strain behind Congo outbreak
NanoViricides (NYSE-A:NNVC), the US clinical-stage drugmaker, has said its lead drug candidate NV-387 could be effective against the Bundibugyo strain of Ebola virus that has prompted the World Health Organisation to declare a global health emergency. The WHO designated the outbreak in eastern Democratic Republic of Congo a Public Health Emergency of International Concern on 17 May, after the virus killed at least 88 people across 336 suspected cases, with two infections also confirmed in neighbouring Uganda.
NanoViricides to raise $2M in registered direct offering
NanoViricides (NYSE-A:NNVC) said it has entered into a securities purchase agreement with a single institutional investor for gross proceeds of approximately $2 million in a registered direct offering. Under the terms of the agreement, the company will sell just over 1.3 million common shares, or pre-funded warrants in lieu thereof, together with accompanying warrants to purchase an equal number of common shares.
NanoViricides says Phase I antiviral drug could address gap exposed by hantavirus cruise ship outbreak
NanoViricides (NYSE-A:NNVC) is pointing to its lead drug candidate NV-387 as a potential solution to a critical gap in infectious disease preparedness, as a deadly hantavirus outbreak aboard a cruise ship triggers a costly global containment effort. The Connecticut-based clinical-stage company said NV-387 has completed Phase I clinical trials for safety and tolerability in healthy volunteers and has shown effectiveness against multiple virus families in lethal animal models, including coronaviruses, RSV, influenza, monkeypox and measles, tested via the same respiratory route through which Andes hantavirus spreads.
NanoViricides antiviral drug NV-387 wins FDA Orphan Drug Designation for measles treatment
NanoViricides (NYSE-A:NNVC) said on Monday its broad-spectrum antiviral drug NV-387 has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration, a regulatory milestone the company said could help accelerate the drug's path to approval as a measles treatment. The designation, granted by the FDA's Office of Orphan Products Development, makes NanoViricides eligible for tax credits on qualified clinical trials, exemption from certain user fees, and up to seven years of market exclusivity following approval.
NanoViricides seeks FDA's rare pediatric disease designation for antiviral candidate NV-387 - ICYMI
NanoViricides (NYSE-A:NNVC) CEO Dr. Anil Diwan talked with Proactive about the company's recent FDA application for rare pediatric disease designation for its antiviral candidate NV-387, highlighting both the scientific and commercial implications of the move.
NanoViricides seeks rare pediatric disease status for measles drug NV-387
NanoViricides (NYSE-A:NNVC) said on Tuesday it has filed an application with the US Food and Drug Administration for Rare Pediatric Disease Drug designation for its antiviral candidate NV-387 as a treatment for measles. The clinical-stage company said the application, submitted to the FDA's Office of Orphan Products Development, is expected to be reviewed alongside a separate orphan drug designation request filed in February.
NanoViricides to begin Phase II trial of MPox treatment in Congo
NanoViricides (NYSE-A:NNVC) said on Wednesday it expects to begin a Phase II clinical trial of its antiviral candidate NV-387 for the treatment of mpox in the Democratic Republic of Congo (DRC) shortly. The company said site preparations are underway, led by contract research organization Om Sai Clinical Research and local partners in the DRC.
NanoViricides completes manufacturing of NV-387 oral drug ahead of Phase II mpox trial
NanoViricides (NYSE-A:NNVC) said on Wednesday it has completed manufacturing of its NV-387 oral drug product, clearing a key step toward dosing patients in an upcoming clinical trial for mpox. The clinical-stage antiviral drug developer said the drug product, formulated as “NV-387 Oral Gummies,” is ready for use once clinical trial sites are prepared to begin patient dosing.
NanoViricides CEO discusses progress of broad-spectrum antiviral candidate NV-387 - ICYMI
NanoViricides (NYSE-A:NNVC) earlier this week provided an update on the advancement of its broad-spectrum antiviral candidate NV-387, outlining progress in Mpox clinical development and confirming orphan drug designation filings for multiple indications. Speaking to Proactive, CEO Dr Anil Diwan said the company has completed the full clinical trial application required to initiate a Phase 2 study of NV-387 in the Democratic Republic of Congo for Mpox.
NanoViricides advances broad-spectrum antiviral NV-387 towards Phase II MPox study
NanoViricides has provided an update on the development of its investigational antiviral NV-387, alongside the filing of its quarterly report for the fiscal quarter ending December 31, 2025. NanoViricides said it is preparing to advance NV-387 into a Phase II clinical trial for Monkeypox (MPox) in the Democratic Republic of Congo.
NanoViricides seeks FDA orphan status for MPox drug
NanoViricides (NYSE-A:NNVC), a clinical-stage biotechnology company developing broad-spectrum antiviral therapies, has filed for Orphan Drug Designation (ODD) with the US Food and Drug Administration (FDA) for its lead candidate NV-387 as a treatment for MPox. If granted, the designation could provide NanoViricides with tax credits for clinical trials, exemption from certain user fees, and up to seven years of market exclusivity after approval.
NanoViricides seeks orphan drug status with US FDA for measles treatment
NanoViricides (NYSE-A:NNVC), a clinical-stage biotechnology company developing broad-spectrum antivirals, said on Tuesday it has filed an application with the US Food and Drug Administration (FDA) for Orphan Drug Designation for its experimental drug NV-387 as a treatment for measles. If granted, the designation would provide the company with incentives including tax credits for qualified clinical trials, exemptions from certain FDA user fees, and potential seven-year market exclusivity following approval.
