Daré Bioscience, Inc. (NASDAQ: DARE) shares surged by 74.16% to $4.38 as of the last check during morning trading following the release of encouraging interim data from a Phase 3 clinical trial.
Positive Interim Analysis Supports Efficacy and Safety
The trial evaluates the contraceptive effectiveness, safety, and acceptability of Ovaprene, DARE’s investigational monthly, hormone-free intravaginal contraceptive. Notably, no FDA-approved products currently exist within this contraceptive category, placing Ovaprene in a potentially groundbreaking position.
The study’s Data Safety Monitoring Board (DSMB) conducted a planned interim review and recommended that the trial continue without any modifications. The interim analysis revealed that approximately 9% of women using Ovaprene experienced pregnancy—aligned with prior expectations and data from the pre-pivotal postcoital test study. The effectiveness of ovaprene as a hormone-free contraception is well supported by these studies.
Crucially, during the review, no significant safety issues were brought forward. Vaginal odor was the most frequent product-related adverse event, causing almost 17% of participants to stop the research. Overall tolerability remained acceptable in spite of this, and most women who finished the experiment had a high propensity to use Ovaprene if it were made commercially accessible.
A New Direction for Women’s Health
Ovaprene has the potential to address a significant unmet need in the contraceptive market, according to Daré Bioscience, which expressed confidence about these findings. The business sees Ovaprene as a potentially game-changing solution in reproductive health, given the rising desire among American women for hormone-free birth control solutions.
Commercial Prospects with Bayer and Future Milestones
Commercial momentum may accelerate if Bayer elects to exercise its exclusive U.S. commercialization rights following trial completion. This decision would involve a $20 million payment to Daré Bioscience.
In total, Daré Bioscience stands to gain up to $310 million in commercial milestone payments, along with double-digit tiered royalties on net sales. These payments are subject to a minority interest provision under a royalty purchase agreement made in April 2024.
