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NanoViricides announced that its Board of Directors has approved a 1-for-20 reverse split of all of the company's capital stock, including its common stock, which will be effective after the market closes on September 23. The common stock will begin trading on a split-adjusted basis on September 24. The company's common stock will continue to trade on the NYSE American under the symbol "NNVC" but will trade under a new CUSIP Id.

NanoViricides' first drug candidate, NV-HHV-101, is on track with required preclinical GLP Safety and Toxicology studies moving towards human clinical trials. NV-HHV-101 has been found to be safe and well tolerated in the clinical observation portion of the GLP Safety/Toxicology study of NV-HHV-101 as a dermal treatment. The in-life stage of the first part of the GLP studies is complete, allowing assessment of clinical observations. The company is waiting on the full histology studies to assess the effects on all primary organs. The first of these GLP studies, a GLP safety and tolerability study following dermal treatment, was conducted using minipigs. Topical treatment of the skin at all doses was well tolerated in all animals and all measured parameters remained within normal range in the study. Additional studies required for the Safety and Toxicology datasets for filing an IND are in progress. The company anticipates advancing NV-HHV-101 into human clinical trials for topical dermal treatment of the shingles rash as the initial indication, assuming that these studies are successful. The company believes that its dermal topical cream for the treatment of shingles rash will be its first drug heading into clinical trials.

NanoViricides that it has received favorable comments from the U.S. FDA on the company's pre-IND application for its lead drug candidate. The company reports that the U.S. FDA has generally agreed in its pre-IND response that the plan of drug development presented by the company to the FDA is generally adequate at this time. The company received the response on May 23. In particular, the Agency has agreed that the company's strategy for drug substance and drug product acceptance criteria is adequate. The Agency has further agreed that the IND-enabling non-clinical studies proposed by the company are generally adequate. The U.S. FDA also said that the proposed design of the IND-opening human clinical studies appears reasonable at this time.

NanoViricides reports that it has submitted the required pre-IND Briefing Documents for its lead drug candidate NV-HHV-101 to the FDA, ahead of schedule. The Company is developing NV-HHV-101 as a broad-spectrum drug against a number of herpes viruses. The Company has chosen shingles rash as the first indication for this drug candidate. It is being developed as a dermal topical cream. It is designed to reduce the local viral load, thereby minimizing rash progression and further nerve damage.

NanoViricides reports that FDA has responded to its request for a pre-IND meeting. In addition, the Company reports that it has completed production of the drug product for the ensuing GLP Safety/Toxicology studies of its lead drug candidate in the HerpeCide program. The Company reports that it has successfully completed the scale-up of the chemistries and production of kg-scale quantities of the drug substance or API, NV-HHV-101. The Company further reports that it has successfully scaled up and manufactured about 10kg of the drug product, as required for the ensuing GLP Safety/Toxicology studies. The FDA has responded to our pre-IND meeting request letter and has asked for the documents to be submitted by April 29th. In addition, consistent with current protocol, the FDA has stated that they will provide a written response to the Company's submission. This written response will guide the Company's IND submission for this drug candidate and indication.