NanoViricides Announces Q3 Earnings Per Share of 10 Cents Compared to 23 Cents Last Year
Clinical Trial Initiation: The company is progressing towards starting a Phase II clinical trial for NV-387 as a treatment for Monkeypox in the Democratic Republic of Congo, with local regulatory approval already obtained.
Monkeypox Epidemic Status: The Africa CDC has declared a "Public Health Emergency of Continental Security" due to the ongoing Monkeypox epidemic, driven by more virulent strains, Clade 1a and 1b, which have higher fatality rates compared to the less virulent Clade 2.
Regulatory Strategy: The company aims to leverage data from international clinical trials to advance NV-387's regulatory status with the US FDA, targeting orphan drug designations for multiple diseases including Monkeypox, Smallpox, and Measles.
Benefits of Orphan Drug Designation: If granted, the Orphan Drug Designation for NV-387 would provide advantages such as expedited FDA meetings, tax credits for R&D, fee waivers, and seven years of market exclusivity for the approved indications.
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NanoViricides: Fiscal Q3 Earnings Snapshot
Company Financial Performance: NanoViricides Inc. reported a loss of $2.2 million in its fiscal third quarter, equating to a loss of 14 cents per share.
Location and Reporting Source: The company is based in Shelton, Connecticut, and the information was generated by Automated Insights using data from Zacks Investment Research.
