Shares of Dare Bioscience Inc. rose more than 35% in after-hours trading Tuesday after the Food and Drug Administration approved Xaciato for the treatment of bacterial vaginosis in females 12 years of age and older.
The approval marks the first FDA green light for the San Diego company, which said it is in talks on strategic partnering and other activities aimed at supporting a robust market introduction of the drug in the U.S. next year.
Dare previously received FDA qualified-infectious-disease-product designation for Xaciato, which provides a five-year extension of the three years of market exclusivity available to the product.
Dare shares, which closed Tuesday at $2.12, were recently changing hands at $2.87, up 35.3%, in after-hours trading.
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