Dare Bioscience (DARE) announced the first shipment of XACIATOTM vaginal gel, 2% in connection with the first commercial sale of the product in the United States, triggering a $1.8 million milestone payment to Dare under its global license agreement with Organon (OGN). “This is a major achievement for Dare Bioscience, proving our ability to accelerate the development of much-needed, innovative medicines for women,” said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. “In less than five years since licensing the technology, we advanced a pivotal clinical trial, gained U.S. Food and Drug Administration approval, and ensured supply to support the launch of XACIATO. We look forward to our continued collaboration with Organon and its established sales force to offer this important treatment for bacterial vaginosis in females 12 years or older.” The New Drug Application for XACIATO was supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating XACIATO for the treatment of bacterial vaginosis.
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