Daré Bioscience, Inc. (NASDAQ: DARE) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research, development, and testing of innovative treatments for women’s health. Shares of the biopharma company gained 10.52% during trading hours on Tuesday, December 7, 2021. However, Daré Bioscience shares shot up over 38% during after-hours trading. Over the past three months, Daré Bioscience has seen an average daily volume of 2.25 million shares. However, volume of 14.71 million shares or dollar volume of around $31.19 million had exchanged hands during regular and after-hours trading Tuesday.
Shares of Daré Bioscience jumped after-hours after the company reported it had received U.S. FDA approval for XACIATO, a treatment for bacterial vaginosis in females aged 12 and up. The approval sets XACIATO as a first-line treatment option for bacterial vaginosis and represents the company’s first FDA-approved product with this potential market positioning.
Management says its strategic partnering negotiations and discussions are ongoing. The company says it will hold a conference call once it has executed definitive partnership agreements for the commercialization of XACIATO. Daré Bioscience estimates the commercial launch to take place sometime in 2022.
“The FDA approval of XACIATO marks a major milestone not only for Daré as a company but, importantly, for the 21 million women impacted by bacterial vaginosis,” said Sabrina Martucci Johnson, President, and CEO of Daré Bioscience. “It is our goal as a company to accelerate the development of differentiated products that can improve outcomes and convenience for women. In the case of XACIATO, this FDA approval comes just three years after we licensed this technology. We are grateful to the FDA for their thoughtful review and the alignment on labeling that gives healthcare providers clear insights into how to use XACIATO in those patient populations in greatest need of a therapeutic option, such as pregnant women and women with recurrent episodes of bacterial vaginosis. We hope that this is the first of many FDA approvals in our efforts to improve the lives of women with treatment options that address some of the most persistent unmet needs.”
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