Positive Interim Phase 3 Results Highlight Potential of Ovaprene®, Novel Hormone-Free Contraceptive
Rhea-AI Summary
Daré Bioscience (NASDAQ: DARE) reported positive interim Phase 3 results for Ovaprene, a novel hormone-free, monthly intravaginal contraceptive. A second independent DSMB review of safety data recommended the trial continue without modification.
Interim data from 339 women (1,789 cycles) showed an approximately 9% pregnancy rate, consistent with expectations, no serious device-related adverse events, and no increase or new types of adverse events with prolonged use. About 12% discontinued due to vaginal odor, a 5% decrease versus July 2025 data, and a majority of completers were likely to use Ovaprene if available. The single-arm, open-label Phase 3 study targets at least 2,500 exposure cycles in 2026, with the Pearl Index over 13 cycles as the primary endpoint.
AI-generated analysis. Not financial advice.
Positive
- Second positive DSMB safety review recommends Ovaprene Phase 3 trial continue unchanged
- Interim pregnancy rate about 9%, aligned with pre-pivotal Ovaprene study expectations
- No serious adverse events related to the Ovaprene device identified so far
- No increase or new types of adverse events with prolonged Ovaprene use
- Vaginal-odor–related discontinuations at 12%, down 5 percentage points from July 2025
- Majority of participants completing the study likely or very likely to use Ovaprene
Negative
- Approximately 12% of participants discontinued use due to vaginal odor
- Pivotal Phase 3 trial still ongoing; primary Pearl Index endpoint not yet reported
- Study has reached 1,789 of the targeted 2,500 exposure cycles, leaving enrollment to complete
News Market Reaction – DARE
On the day this news was published, DARE gained 4.37%, reflecting a moderate positive market reaction. Argus tracked a peak move of +24.5% during that session. Argus tracked a trough of -2.5% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $2M to the company's valuation, bringing the market cap to $41.35M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
DARE was down 8.36% pre-news with mixed peer moves: TENX up 2.14%, ALLR up 6.33%, KZR down 0.95%, NRSN down 5.11%, CVKD down 9.91%. Momentum scanner flagged only OKUR, down 3.20% without news.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 01 | Ovaprene rights returned | Positive | -9.2% | Bayer returns Ovaprene rights while positive interim Phase 3 data remain supportive. |
| Nov 11 | Sildenafil Cream webinar | Positive | +6.6% | Clinical data and launch readiness for DARE to PLAY Sildenafil Cream highlighted. |
| Jul 14 | Ovaprene interim data | Positive | +22.9% | Positive interim Phase 3 Ovaprene data; DSMB supports study continuation. |
| Dec 16 | Sildenafil Phase 3 plans | Positive | +0.0% | Plans announced for Phase 3 program in FSAD with large unmet need. |
| Dec 10 | FSAD subgroup analyses | Positive | +2.5% | Positive Phase 2b subgroup analyses show efficacy across age and contraceptive use. |
Across 5 prior clinical trial headlines, 4 saw non-negative price reactions and 1 showed a notable decline after otherwise positive clinical data.
Recent clinical-trial news for Daré Bioscience has centered on Ovaprene and Sildenafil Cream. In July 2025, positive interim Ovaprene Phase 3 data and a 9% pregnancy rate aligned with pre-pivotal results, and the stock rose 22.86%. A December 2025 update on Bayer returning Ovaprene rights but confirming positive interim data saw a -9.24% move. Other clinical updates on Sildenafil Cream and subgroup analyses in 2024–2025 produced modestly positive or flat reactions, underscoring that clinical milestones have often supported, but not guaranteed, favorable trading.
Historical Comparison
Past clinical-trial headlines for DARE produced an average move of about 4.53%. Today’s Ovaprene interim Phase 3 update fits the pattern of data-driven catalysts shaping sentiment.
Historical updates trace Ovaprene from positive interim Phase 3 data in July 2025 through Bayer’s return of rights in December 2025. The current interim Phase 3 results extend that trajectory, adding more safety and efficacy exposure toward the 2,500-cycle target while keeping the pivotal program on course.
Market Pulse Summary
This announcement adds substantial interim Phase 3 evidence for Ovaprene, with a reported 9% pregnancy rate and 1,789 cycles of safety data across 339 subjects. The DSMB again recommended continuing the study without modification, and discontinuations due to vaginal odor fell by 5% versus July 2025 data. In context of earlier Ovaprene updates and clinical milestones across Daré’s pipeline, investors may focus on achieving the 2,500-cycle exposure target, typical-use Pearl Index results, and upcoming FDA discussions.
Key Terms
phase 3 medical
data safety monitoring board medical
intravaginal medical
adverse events medical
serious adverse events medical
pearl index medical
clinicaltrials.gov regulatory
AI-generated analysis. Not financial advice.
Second Positive DSMB Review Supports Continued Study Progress
Interim Phase 3 Results Support Ovaprene’s Differentiation as a First-in-Category, Hormone-Free, Intravaginal Monthly Contraceptive
SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions, today announced positive interim safety and efficacy results from its ongoing Phase 3 clinical trial evaluating the contraceptive effectiveness, safety and acceptability of Ovaprene®, the company’s investigational monthly, hormone-free intravaginal contraceptive. There currently are no FDA-approved, hormone-free, monthly intravaginal contraceptives.
The trial’s independent Data Safety Monitoring Board (DSMB) conducted a planned interim analysis focused on reviewing safety data from the study, and recommended the study continue without modification.
The DSMB’s findings and recommendation to continue the study are consistent with those from its prior interim analysis conducted in July 2025.
As was the case with the data presented to the DSMB in July 2025, these interim data show that approximately
No new types of adverse events or tolerability concerns were identified. Neither an increase in the frequency of adverse events nor the emergence of new types of adverse events was observed with prolonged Ovaprene use. Approximately
“We are encouraged by these interim results and this second positive DSMB review,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Millions of women in the U.S. are seeking effective, hormone-free birth control, and Ovaprene has the potential to address a significant unmet need and transform the contraceptive landscape. We look forward to advancing toward the primary endpoint analysis as we complete the study.”
According to the FDA’s birth control guide, the number of pregnancies expected using short-acting hormonal contraceptive methods—including oral contraceptives (“the pill”), the patch (transdermal system), and the vaginal ring—is seven per 100 women, and the number of pregnancies expected using male condoms is 13 per 100 women, and 17 per 100 women using diaphragms or sponges with spermicide.
For the interim analysis, the DSMB reviewed data from 339 study subjects, contributing 1,789 menstrual cycles of safety data, representing a meaningful proportion of the study’s 2,500-cycle target. The ongoing pivotal Phase 3 trial is a multicenter, single-arm, open-label study enrolling women aged 18–40 across five sites. The study protocol calls for at least 2,500 cycles of exposure and at least 250 subjects completing 13 menstrual cycles of use. Based on current enrollment trends, the Company expects to achieve 2,500 cycles of exposure before 250 subjects complete 13 menstrual cycles of use. Interim safety data reviewed by the DSMB indicate that prolonged product use was not associated with the emergence of new types of adverse events or an increase in the frequency of adverse events, which the Company believes may support the sufficiency of fewer than 250 subjects completing 13 menstrual cycles of use to evaluate Ovaprene's safety profile. The Company intends to engage with FDA regarding these findings. The Company currently expects to complete enrollment sufficient to achieve at least 2,500 cycles of exposure in 2026. The primary objective of the study is to assess the typical-use pregnancy rate over 13 menstrual cycles, expressed as the Pearl Index, a standard measure of contraceptive effectiveness. Secondary objectives include assessment of Ovaprene’s 13-cycle cumulative pregnancy rate, safety, acceptability, product fit/ease of use, and vaginal health. For more information about the study, please visit clinicaltrials.gov (ID # NCT06127199).
About Daré Bioscience
Daré Bioscience is a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions. Every innovation Daré advances is based in advanced science and backed by rigorous, peer-reviewed research. From contraception to menopause, pelvic pain to fertility, vaginal health to infectious disease, Daré is working to close critical gaps in care using science that serves her needs.
For decades, women have been told to “wait it out” or “live with it,” while innovations that could improve their quality of life languish in the regulatory or funding pipeline. With growing awareness around menopause, sexual health, and vaginal health, the conversation is shifting. However, access to real, evidence-based solutions continues to lag. Daré was founded to change that. As a female-led health biotech company, Daré is accelerating the development of credible, science-based solutions that meet the high standards of clinical rigor – randomized, controlled trials; validated endpoints; peer-reviewed publications; and current Good Manufacturing Practice (cGMP) requirements.
To learn more about Daré’s mission to deliver differentiated therapies for women and its innovation pipeline, please visit www.darebioscience.com.
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré’s CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.
Daré may announce material information about its finances, products and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts, and social media channels. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website, to follow Daré Bioscience, Inc. on LinkedIn, and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “prepare,” “seek,” “should,” “would,” “target,” “objective,” “positioned,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Ovaprene’s potential as a safe and effective first-in-category, hormone-free, intravaginal monthly contraceptive, Ovaprene’s potential to be the first U.S. Food and Drug Administration (FDA)-approved hormone-free, monthly intravaginal contraceptive, the importance of the interim results from the ongoing pivotal Phase 3 study of Ovaprene to Daré and Ovaprene, that enrollment in the study will be completed in 2026, that fewer than 250 subjects completing 13 menstrual cycles of use may support an evaluation of Ovaprene’s safety profile, Daré’s intention to engage with FDA regarding the study protocol, the anticipated timing of the primary endpoint analysis, and Ovaprene’s potential, if approved, to address an unmet medical need in hormone-free contraception. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing FDA-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, completing or conducting clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; the potential that a product candidate in clinical development may never advance into or through a pivotal clinical study or obtain FDA or foreign regulatory approval; the risk that Daré’s product candidates may fail to demonstrate acceptable safety and tolerability or sufficient efficacy in clinical trials; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates, including that fewer than 250 subjects completing 13 menstrual cycles of use is sufficient to support an evaluation of Ovaprene’s safety profile; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates, or that the duration of a study or number of study subjects must be significantly greater than anticipated; Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; Daré’s dependence on grants and other financial awards from governmental entities and a private foundation; Daré’s ability to maintain compliance with Nasdaq’s continued listing requirements and continue to have its common stock listed on The Nasdaq Capital Market; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage, pricing and reimbursement from third-party payors; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; and cybersecurity incidents or similar events that compromise Daré’s technology systems and/or significantly disrupt Daré’s business or those of third parties on which Daré relies. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the U.S. Securities and Exchange Commission, or SEC, including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Contacts:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.
