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News about Daré Bioscience, Inc. (NASDAQ: DARE) centers on its efforts to advance and commercialize women’s health products across contraception, sexual health, vaginal health and menopause. Company press releases highlight progress on clinical programs, grant-funded research, regulatory interactions and commercialization plans for both prescription and consumer health offerings.
Recent news has focused on DARE to PLAY Sildenafil Cream, a proprietary topical arousal cream designed specifically for women. Daré reports that this first-of-its-kind topical sildenafil formulation for women has been evaluated in multiple clinical studies and is being introduced via a Section 503B outsourcing facility as an evidence-backed option to enhance genital blood flow and arousal response. Updates describe pre-order availability in select U.S. states, webinar events with sexual health clinicians and the role of DARE to PLAY in the company’s broader 503B compounding strategy.
Another major news theme is Ovaprene, Daré’s investigational hormone-free monthly intravaginal contraceptive. Releases discuss interim Phase 3 results, data safety monitoring board recommendations to continue the pivotal study without modification, and the return of commercialization rights to Daré from a prior license partner. These items provide context on clinical progress, safety and tolerability findings, and the company’s plans to maximize the asset’s value.
Daré’s news flow also covers non-dilutive grant funding and collaborations, including multi-year support for DARE-LARC1, a long-acting contraceptive based on the DARE-IDDS programmable drug delivery platform, and grants for non-hormonal intravaginal contraceptive research and HPV-related programs. Corporate updates detail quarterly financial results, Nasdaq listing matters, and strategic initiatives that combine near-term revenue opportunities with long-term pipeline development. Investors and observers can use the DARE news page to follow these developments and track how clinical, commercial and funding milestones evolve over time.
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.
Daré Bioscience, Inc. (NASDAQ: DARE) will host a conference call on March 30, 2023, at 4:30 p.m. ET to discuss its financial results for the year ended December 31, 2022, along with a company update. Investors can access the call via phone or through a live webcast on the company's website. Daré focuses on women's health innovations, with FDA-approved products like XACIATO™ for bacterial vaginosis and a robust pipeline including Ovaprene®, Sildenafil Cream, and DARE-HRT1. The company aims to enhance treatment options across various domains of women's health.
Daré Bioscience (NASDAQ: DARE) has announced that its President and CEO, Sabrina Martucci Johnson, will present at the 35th Annual Roth Conference from March 12-14, 2023, in Laguna Niguel, CA. Johnson's presentation is set for March 14 at 8:30 a.m. PDT, with a live webcast available here and archived until March 28. The management team will also hold one-on-one meetings with investors at the conference. Daré focuses on innovative women’s health products and has FDA-approved XACIATO for bacterial vaginosis, alongside other promising candidates.
Daré Bioscience (NASDAQ: DARE) announced the initiation of a Phase 1 clinical trial for DARE-PDM1, aimed at treating primary dysmenorrhea with a novel vaginal delivery system for diclofenac. This phase involves around 36 healthy premenopausal women to assess pharmacokinetics and safety, with the potential to provide a new treatment option in a market projected to grow from USD $13 billion in 2022 to USD $28.5 billion by 2029. DARE-PDM1 could become the first FDA-approved vaginal diclofenac product, enhancing pain relief while reducing systemic side effects associated with oral NSAIDs.
Daré Bioscience, a leader in women’s health innovation, announced participation in key February conferences. CEO Sabrina Martucci Johnson will present at the 2023 BIO CEO & Investor Conference from February 6-9, with a presentation scheduled for February 7 at 3:00 p.m. EST. The company will also be involved in the virtual SVB Securities Global Biopharma Conference from February 13-16, and Johnson will join a panel at the Women’s Health Innovation Series in Boston on February 16 at 3:30 p.m. EST. Daré focuses on advancing innovative products in women’s health, including contraceptives and treatments for sexual health disorders.
Daré Bioscience announced plans to advance DARE-HRT1, an investigational intravaginal ring for treating vasomotor symptoms (VMS) due to menopause, into a single Phase 3 efficacy trial. This product could become the first FDA-approved monthly intravaginal ring delivering both estradiol and progesterone. Positive topline results from prior Phase 1 and Phase 1/2 trials support its potential. The company seeks FDA approval via the 505(b)(2) pathway, leveraging existing data and aiming for a new drug application for women with intact uteri experiencing moderate to severe VMS.