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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.
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Daré Bioscience, Inc. (NASDAQ: DARE) announced the initiation of a Phase 1 clinical study for its Sildenafil Cream, a potential treatment for female sexual arousal disorder (FSAD). The study aims to assess the pharmacodynamic and pharmacokinetic properties of the cream using thermography, with the goal of collecting quantitative data to complement patient-reported outcomes from the ongoing Phase 2b RESPOND study. This innovative cream formulation is designed to increase blood flow to genital tissues, addressing issues similar to erectile dysfunction in men. Approximately 15 women will be enrolled, and completion is planned for 2023. Topline data for the Phase 2b study is anticipated in Q2 2023, providing critical insights into the product's efficacy.
Daré Bioscience (NASDAQ: DARE) has announced that its Chief Scientific Officer, David Friend, Ph.D., will present at the Global Pharma & Drug Delivery Summit 2023 in Frankfurt, Germany, scheduled for April 24-26, 2023. His presentation will focus on the Safety and Pharmacokinetic Assessment of Ovaprene, a once-monthly non-hormonal vaginal contraceptive.
Ovaprene is designed to provide a hormone-free contraceptive option through a unique knitted polymer barrier that hinders sperm motility. The company recently received an FDA-approved Investigational Device Exemption to conduct a pivotal clinical study to evaluate Ovaprene’s effectiveness and safety over 12 months. This research is essential for a future Premarket Approval submission to the FDA, and subject recruitment is anticipated to begin in mid-2023.
Daré Bioscience announced plans to advance DARE-HRT1 into a single Phase 3 efficacy trial aimed at treating vasomotor symptoms (VMS) experienced during menopause. This investigational intravaginal ring (IVR) is noteworthy for potentially being the first FDA-approved monthly delivery method for combined estrogen and progesterone therapy. The Phase 1 trial, recently published in Climacteric, demonstrated that DARE-HRT1 was well-tolerated by approximately 30 healthy postmenopausal women. The results support the safety and acceptability of this innovative hormone therapy, which is designed to improve medication compliance and user experience. Daré intends to utilize existing data and pursue the FDA's 505(b)(2) approval pathway for market entry in the U.S.
On April 17, 2023, Daré Bioscience (NASDAQ: DARE) announced CEO Sabrina Martucci Johnson will participate in a panel discussion at the Innovations in Women’s Health Business Conference on April 20, 2023, in Boston, MA. The panel, titled ‘What’s Hot and What’s Next in Women’s Health,’ will run from 4:00-4:45 p.m. Eastern Time and features other notable panelists including Amanda Gorman and Christine Henningsgaard. This event aims to highlight innovative products reshaping women’s health care.
Daré Bioscience is dedicated to advancing women’s health through a diverse portfolio of differentiated therapies, targeting areas such as contraception, vaginal health, and menopause. The company’s first FDA-approved product, XACIATO™, is indicated for bacterial vaginosis treatment. For further details about Daré’s offerings and mission, visit their website.
Daré Bioscience, Inc. (NASDAQ: DARE) announced positive developments in its portfolio, including a license agreement with Organon for its FDA-approved product, XACIATO™, and received $24.1 million in non-dilutive funding during 2022. The company completed two Phase 1/2 clinical studies with positive topline data and gained FDA IDE approval for Ovaprene’s pivotal study. In 2023, Daré anticipates multiple milestones with the first commercial sale of XACIATO and topline data from other programs. Financially, cash and equivalents were at $34.7 million, with R&D expenses slightly decreasing to $30 million.