Shares of Daré Bioscience, Inc. (NASDAQ:DARE) soared by 250% following the release of encouraging interim data from its Phase 3 clinical trial of Ovaprene, a novel hormone-free monthly intravaginal contraceptive under development.
The independent Data Safety Monitoring Board overseeing the trial reviewed the safety findings and recommended the study proceed as planned without any changes. At the time of this interim review, about 9% of women using Ovaprene had reported pregnancies, aligning with the company’s expectations based on earlier clinical trials conducted before this pivotal study.
No major safety issues surfaced during the interim analysis, though roughly 17% of participants stopped using the product due to vaginal odor — the most frequently reported side effect linked to the contraceptive. Among those who completed the trial, most indicated they would be “very likely” or “likely” to continue using Ovaprene if it were made 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,” stated Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
This pivotal Phase 3 study is being conducted as a multicenter, single-arm, open-label trial across five sites, targeting women aged 18 to 40. Around 115 participants had either completed or were still participating at the time of the interim analysis, with a goal of enrolling approximately 250 women who will use the product for about one year.
Bayer (USOTC:BAYRY) holds the option to secure exclusive commercialization rights for Ovaprene in the U.S. after the trial’s completion, contingent upon a $20 million payment to Daré. Additionally, Daré could earn up to $310 million through commercial milestones, along with tiered royalties based on net sales.
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