NanoViricides

NNVC

Market cap $25.1M

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 (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.

SHELTON, CT / ACCESS Newswire / April 7, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the "Company"), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announced today that it has filed an application for "Rare Pediatric Disease Drug" Designation (RPDD) for NV-387 as a Treatment for Measles with the US FDA Office of Orphan Products Development (OOPD). This RPDD application is expected to be joined together with the Orphan Drug Designation application for NV-387 as a Treatment for Measles that the Company has filed in February, 2026.

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.

SHELTON, CT / ACCESS Newswire / April 1, 2026 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company") today announced that a Phase II Clinical Trial of Monkeypox Treatment by NV-387 is expected to begin soon in the Democratic Republic of Congo (DRC). Clinical Trial Site preparations are being performed by our CRO in India, Om Sai Clinical Research Pvt.

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.

SHELTON, CT / ACCESS Newswire / March 11, 2026 / NanoViricides, Inc. (AMEX:NNVC) (the "Company"), a clinical stage leader developing revolutionary broad-spectrum antiviral drugs that the virus cannot escape, is pleased to announce that it will be presenting at NIBA's 152nd Investment Conference in Fort Lauderdale, Florida. NanoViricides announces herewith that the manufacture of the drug product for this clinical trial, "NV-387 Oral Gummies" is now complete, in anticipation of starting dosing in patients as soon as site readiness is established.

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 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 (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.