Daré Bioscience, Inc. develops and commercializes women’s health therapies across contraception, fertility, vaginal health, and sexual health. Its updates center on XACIATO, DARE to PLAY™ Sildenafil Cream, and investigational programs such as DARE-HPV and DARE-PTB1, an intravaginal ring program for prevention of preterm birth.
Recurring news themes include financial results, company updates, product availability through prescription and 503B channels, FDA and IND-related development milestones, clinical-program disclosures, and non-dilutive funding from government sources. Coverage also reflects Daré’s public reporting on product candidates, trials, financing, and business development.
Daré Bioscience (NASDAQ: DARE) announced its premier sponsorship of Managing Menopause After Breast Cancer, an educational program scheduled for October 20, 2026.
Presented by HERmedicine and the OncoMenopause Consortium in San Diego, the continuing medical education program will cover hormonal and nonhormonal treatment approaches, sexual health, and quality of life after breast cancer. Daré also plans to present a scientific poster with data from a Phase 1 study of investigational Sildenafil Cream, 3.6% in postmenopausal women at The Menopause Society’s 2026 Annual Meeting, held October 20–24, 2026.
Daré Bioscience (DARE) launched CEO Corner, a video series featuring Founder, President and CEO Sabrina Martucci Johnson for investors. The inaugural episode introduces the series and explains its role in sharing context behind the company’s strategy beyond formal announcements.
The company plans future episodes covering its commercial portfolio, clinical development programs, upcoming milestones and approach to long-term value creation in women’s health. The latest episode is available at darebioscience.com/ceocorner and will remain accessible for approximately 90 days after its initial release.
Daré Bioscience (DARE) will present Phase 1 Sildenafil Cream safety and drug-exposure data at the SMSNA meeting on October 9, 2026. Medical Director Annie Thurman will present results from an open-label, single-dose, randomized study comparing topical cream with oral sildenafil in healthy adult men.
At the 71 mg topical dose, mean maximum blood concentration was approximately 187-fold lower than with the 50 mg oral dose. Total exposure, measured by area under the curve, was approximately 33- to 34-fold lower. All treatment-emergent adverse events were mild, with no serious or severe adverse events, deaths or discontinuations due to treatment-emergent adverse events.
Daré is continuing activities to advance the cream toward the FDA’s 505(b)(2) regulatory pathway as a potential treatment for female sexual arousal disorder. The findings were recently published in Sexual Medicine.
Daré Bioscience (DARE) announced a newly issued U.S. patent covering topical lopinavir and ritonavir formulations for HPV-related cervical conditions. U.S. Patent No. 12,678,439 was issued to licensor Douglas Pharmaceuticals on July 14, 2026. Daré holds an exclusive U.S. license under a 2023 agreement and expects patent protection into at least 2039.
Its investigational DARE-HPV is a soft gel vaginal insert for persistent high-risk HPV infection. A randomized, placebo-controlled, double-blind Phase 2 study is testing lower and higher doses against placebo in approximately 100 women, using daily treatment for up to 21 days. Its primary endpoint is HPV clearance three months after treatment; topline results are expected in 2027. Development is supported by approximately $10 million from ARPA-H and a $2.0 million NIAID award. No pharmacologic treatment for HPV infection is currently FDA-approved.
Daré Bioscience (DARE) reported peer-reviewed publication of a Phase 1 study in healthy men showing its proprietary topical Sildenafil Cream, 3.6% produces substantially lower systemic exposure than 50 mg oral sildenafil.
The open-label, randomized study enrolled 62 men who received single doses of 36 mg or 71 mg topical sildenafil cream, with or without condom use, or a 50 mg oral tablet. All 14 treatment-emergent adverse events were mild, with 7 occurring in 5 participants given oral sildenafil, and there were no serious events, severe events, deaths, or discontinuations. Mean maximum plasma concentrations for topical groups ranged from 969 to 1,274 pg/mL versus 238,000 pg/mL for oral dosing, with relative bioavailability of 2.55% to 3.20%. At the 71 mg topical dose, mean maximum plasma concentration was about 187-fold lower and overall exposure (AUClast and AUCinf) about 33–34-fold lower than the 50 mg oral dose.
Daré Bioscience (DARE) announced that its pre-recorded presentation for the H.C. Wainwright 28th Annual Global Investment Conference is now available on-demand starting September 11, 2026, at 7:00 a.m. ET.
The presentation, led by President and CEO Sabrina Martucci Johnson, covers an overview of the company and recent corporate and clinical developments. It can be accessed via the conference link or through the Presentations, Events & Webcasts page in the Investors section of darebioscience.com and will remain available for 90 days. Management will also attend the conference in New York, NY, from September 14–16, 2026, for one-on-one investor meetings.
Daré Bioscience (NASDAQ: DARE) announced a new NIH funding award of approximately $908,000 from the Eunice Kennedy Shriver National Institute of Child Health and Human Development to support year-long preclinical development of DARE-PTB2, an early-stage investigational program for preventing idiopathic preterm birth.
The notice of award also includes recommended future-year support of about $1.3 million for initial pharmacokinetic, safety, and toxicity studies. This non-dilutive grant builds on an earlier $400,000 NICHD award in July 2023 that funded proof-of-concept target validation studies with the University of South Florida.
Daré Bioscience (NASDAQ: DARE) announced that President and CEO Sabrina Martucci Johnson participated in the Virtual Investor “Why Now” on-demand series, where she presented the company’s investment thesis. The webcast highlights Daré’s mission to advance innovative, science-based and capital-efficient solutions addressing significant unmet needs in women’s health.
According to Daré Bioscience, Ms. Johnson emphasized the company’s first direct product launch, its diversified development pipeline, and its collaboration-driven strategy. The video webcast is available for on-demand viewing, and additional information about Daré’s focus areas across contraception, menopause, sexual and vaginal health, fertility, and infectious disease is available on the company’s website.
Daré Bioscience (NASDAQ: DARE) announced publication in Menopause - The Journal of The Menopause Society of Phase 1 data for its proprietary topical sildenafil cream 3.6% in healthy postmenopausal women. The open-label, within-participant dose-escalation study enrolled 21 women (mean age 57); 19 completed all four treatment periods.
Participants received a placebo dose followed by escalating doses of Sildenafil Cream containing 50 mg, 100 mg and 200 mg sildenafil citrate, with 14- to 16-day washout periods. According to Daré, all evaluated doses were well tolerated, all treatment-emergent adverse events were mild, and no serious or cardiac treatment-emergent adverse events or symptomatic orthostatic hypotension were observed.
At the 100 mg dose, which was later used in Daré’s Phase 2b RESPOND study, maximum plasma sildenafil concentration was approximately 3,810 pg/mL, about two orders of magnitude below the 450,000 pg/mL reported in men after a 100 mg oral dose in a separate study. Daré stated that these findings support localized genital delivery with limited systemic exposure and reinforce the potential of its DARE to PLAY compounded sildenafil cream and its proprietary Sildenafil Cream, which it aims to advance under the FDA’s 505(b)(2) pathway.
The company is continuing activities to seek future FDA approval of its proprietary Sildenafil Cream while, in parallel, launching DARE to PLAY Sildenafil Cream, a 503B compounded version. According to Daré, prescription dispensing and initial product revenue for DARE to PLAY Sildenafil Cream are expected to begin in Q3 2026, creating an opportunity for earlier commercial exposure while the regulatory program proceeds.
Daré Bioscience (NASDAQ: DARE) announced that President and CEO Sabrina Martucci Johnson participated in a Virtual Investor CEO Connect segment, where she described the company’s transition from a development-stage biotech to a commercial-stage women’s health company.
According to Daré Bioscience, the discussion highlighted the launch of Flora Sync LF5™ and preparations for DARE to PLAY™ Sildenafil Cream to begin generating revenue. Johnson also described efforts to build a scalable commercial infrastructure to support multiple products, including customer acquisition, provider engagement and market access initiatives.
The segment further covered pipeline developments, including Ovaprene’s positive interim Phase 3 results and DARE-HPV’s advancement into Phase 2, as well as potential value-driving catalysts the company sees over the next 12–18 months. The CEO Connect recording is now available for investors to view.