DARE to PLAY™ Sildenafil Cream
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DARE to PLAY™ Sildenafil Cream Now Available for Pre-Order by Prescription: First Evidence-Based Topical Arousal Cream for Women Begins Commercial Rollout in Select States via 503B Outsourcing Facility
Globenewswire· 2025-12-10 13:00
Developed and evaluated specifically for women, DARE to PLAY™ Sildenafil Cream is a first-of-its-kind female arousal cream, a non-hormonal topical cream shown in clinical studies to increase genital blood flow in 10–15 minutes, and improve arousal sensations based on clinically-validated endpoints. Market introduction of DARE to PLAY™ is expected to mark a breakthrough in women’s sexual health and represents important progress toward closing one of medicine’s most persistent gender gaps. SAN DIEGO, Dec. 10, ...
Daré Bioscience Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-13 21:01
DARE to PLAY™ Sildenafil Cream on Track to Launch Before Year End via 503B Pathway, Paving the Way for Near-Term Product RevenuePositive Interim DSMB Outcome for Ovaprene® Phase 3 Study Supports Continued EnrollmentMultiple Grant-Funded Programs Advance, Including to Address HPV and Long-Acting as well as Non-Hormonal ContraceptionFour Commercially Available Solutions for Women Expected Over the Next Two Years In addition to DARE to PLAY™ Sildenafil Cream, Commercialization of DARE to RESTORE™ Vaginal Probi ...
Daré Bioscience Highlights Commercial Launch Readiness for DARE to PLAY™ Sildenafil Cream; November 17th Webinar to Feature Leading Clinicians Discussing Clinical Data and Potential Impact in Women’s Sexual Health
Globenewswire· 2025-11-11 13:00
Core Insights - Daré Bioscience is hosting a webinar on November 17, 2025, to discuss its innovative product DARE to PLAY™, a topical sildenafil cream designed specifically for women [1][2] - DARE to PLAY™ is the first evidence-backed sildenafil cream for women, showing increased genital blood flow within 10 to 15 minutes of application and improvements in arousal sensations [2][3] - The product is expected to be commercially available through a 503B outsourcing facility by the end of 2025, marking a significant advancement in women's sexual health solutions [2][3] Company Overview - Daré Bioscience focuses on addressing gaps in women's health through science-based solutions, with a commitment to rigorous clinical research and development [4][5] - The company aims to provide credible, evidence-based therapies for various women's health issues, including sexual health, menopause, and fertility [4][5] - Daré is a female-led organization recognized for its contributions to innovation and advocacy in women's health, with leadership acknowledged in industry publications [6] Product Details - DARE to PLAY™ is a unique formulation that enhances genital blood flow and arousal response, supported by FDA-reviewed clinical data [2][3] - The product's anticipated launch will be the first time a topical sildenafil formulation manufactured under cGMP requirements is available to healthcare providers [2][3] - The webinar will feature expert clinicians discussing the product's benefits and clinical data, providing an opportunity for participants to join a product alert list [3]
Daré Bioscience Reports Second Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-08-14 20:01
Core Insights - Daré Bioscience is on track to launch DARE to PLAY™ Sildenafil Cream in Q4 2025 through a 503B compounding pathway, with expected product revenue beginning in the same quarter [1][4][6] - Positive interim results from the Ovaprene® Phase 3 study support continued enrollment, highlighting the potential of this hormone-free contraceptive [1][4][6] - The company is advancing multiple grant-funded programs targeting HPV and long-acting contraception, with four commercially available solutions for women anticipated [1][2][4] Financial Highlights - For Q2 2025, Daré reported a total revenue of $(21.2) million, a decrease from $22.4 million in Q2 2024 [19] - General and administrative expenses were $2.4 million, slightly down from $2.5 million year-over-year, while research and development expenses decreased significantly by 71% to $1.4 million [11][19] - The company had approximately $5.0 million in cash and cash equivalents as of June 30, 2025, with a working capital deficit of approximately $12.6 million [11][21] Product Development and Pipeline - DARE to PLAY™ Sildenafil Cream is positioned as a near-term commercial opportunity, with a direct-to-patient campaign launched in collaboration with Rosy Wellness [4][6] - Ovaprene® is being developed as a first-in-category, hormone-free intravaginal contraceptive, with interim pregnancy rates aligning with company expectations [4][6] - The DARE-HPV program is funded by an ARPA-H award and NIH grant, focusing on treating persistent high-risk HPV infections [4][6] Strategic Initiatives - The company is executing a dual-path strategy aimed at unlocking both near-term revenue and long-term value through the commercialization of its products [6] - Discussions with the FDA are ongoing regarding endpoint assessments for the Phase 3 clinical studies of Sildenafil Cream [4][6] - Daré is also targeting the compounded hormone therapy market, estimated at $4.5 billion, with proprietary monthly hormone therapy expected to launch in late 2026 [4][6]