NanoViricides Gets Favorable FDA Comments On Pre-IND Application; Stock Surges

(RTTNews) - NanoViricides Inc. (NNVC) said that it has received favorable comments from the US FDA on the Company's pre-IND application for its lead drug candidate.

In Monday pre-market trade, NNVC is currently trading at $0.3401, up $0.07 or 23.67 percent.

The Agency has agreed that the company's strategy for drug substance and drug product acceptance criteria is adequate. The Agency has also agreed that the IND-enabling non-clinical studies proposed by the Company are generally adequate, the company said in a statement.

The U.S. FDA also said that the proposed design of the IND-opening human clinical studies appears reasonable at this time.

The company has chosen NV-HHV-101, a broad-spectrum drug candidate in its HerpeCide program, as its lead candidate. The candidate is formulated as a skin cream for the treatment of shingles rash, the Company's first target indication.

The company currently plans to perform clinical studies for shingles rash reduction, which would enable a sub-billion dollar market opportunity.