Shares of Daré Bioscience Surge Over 100% on Positive Interim Phase 3 Results for Ovaprene, a First-of-Its-Kind Hormone-Free Monthly Contraceptive
The woman’s health focused biopharmaceutical company Daré Bioscience (NASDAQ: DARE) has released encouraging interim results from its ongoing Phase 3 clinical trial evaluating Ovaprene®, a novel hormone-free, intravaginal contraceptive. The investigational product is the first in its category and, if approved, would offer a non-hormonal, monthly option for birth control, filling a gap in the contraceptive market.
The analysis, conducted by an independent Data Safety Monitoring Board (DSMB), reviewed safety data from the study and recommended continuation without modification. At the time of the interim analysis, the pregnancy rate among participants was approximately 9%, aligning with expectations based on prior studies and comparable to some existing contraceptive options, including hormonal pills and male condoms.
Crucially, no new safety or tolerability issues were identified, and the overall safety profile remained favorable. While 17% of participants discontinued due to vaginal odor—the most frequently reported product-related adverse event—there were no serious safety concerns. Additionally, most participants who completed the study indicated they would likely 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. “With millions of women in the U.S. seeking effective, hormone-free birth control, Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape.”
The ongoing multicenter Phase 3 trial is a single-arm, open-label study enrolling women aged 18–40 across five sites. The study aims to enroll approximately 250 participants, each using Ovaprene for about 12 months (13 menstrual cycles). The primary endpoint is the pregnancy rate, measured by the Pearl Index, while secondary endpoints include safety, acceptability, ease of use, and vaginal health.
Ovaprene’s progress is also being closely watched by pharmaceutical giant Bayer, which holds the exclusive option to commercialize the product in the U.S. If Bayer exercises its option following successful trial results, it will pay Daré $20 million and potentially up to $310 million in milestone payments, along with double-digit tiered royalties on net sales.
With the trial now past its interim review, Daré anticipates sharing final data once the study is completed and fully analyzed. The company believes Ovaprene could become a valuable addition to the contraceptive toolkit, particularly for women seeking a hormone-free alternative to existing short-acting methods like the pill, patch, or ring.
