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Investing.com -- Daré Bioscience, Inc. (NASDAQ:DARE) stock rose 250% following positive interim results from its Phase 3 clinical trial of Ovaprene, the company’s investigational hormone-free monthly intravaginal contraceptive.
The trial’s independent Data Safety Monitoring Board recommended the study continue without modification after reviewing safety data. At the time of the interim analysis, approximately 9% of women treated experienced a pregnancy, which the company stated was consistent with expectations based on pre-pivotal clinical study results.
No serious safety concerns were identified in the interim analysis, though approximately 17% of participants discontinued due to vaginal odor, the most commonly reported product-related adverse event. Participants who completed the study reported they would be very likely or likely to use Ovaprene if it became available.
"We are encouraged by these interim results, which reinforce the potential of our hormone-free contraceptive candidate to provide women with a meaningful alternative to existing hormonal and non-hormonal methods," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
The ongoing pivotal Phase 3 trial is a multicenter, single-arm, open-label study enrolling women aged 18-40 across 5 sites. As of the interim analysis, approximately 115 participants were ongoing or had completed the study, with target enrollment of approximately 250 participants completing about 12 months of use.
Bayer (OTC:BAYRY) holds the right to obtain exclusive U.S. commercialization rights following completion of the pivotal trial, contingent on a $20 million payment to Daré. The company may receive up to $310 million in commercial milestone payments, plus double-digit tiered royalties on net sales.
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