Adamis Pharmaceuticals Corp. shares rose more than 30% on Monday after the biopharmaceutical company said it had filed for U.S. Food and Drug Administration fast-track designation for Tempol for the treatment and prevention of Covid-19.
The San Diego company, which is currently conducting a Phase 2/3 study of Tempol in adults with confirmed Covid-19 infection, said the drug has been shown to have antiviral, anti-inflammatory and antioxidant activity.
The FDA's fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
Adamis said that while the FDA has recently approved oral antiviral Covid-19 drugs, including pills from Pfizer Inc. and the team of Merck & Co. and Ridgeback Biotherapeutics, the company believes Tempol would qualify for the designation because of its unique mechanism of action and safety profile.
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