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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.
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.
Daré Bioscience (NASDAQ: DARE) recently announced the advancement of DARE-HRT1 into a single Phase 3 clinical trial to treat vasomotor symptoms (VMS) associated with menopause. The investigational intravaginal ring (IVR) is designed to deliver bio-identical hormone therapy. Topline results from the completed Phase 1/2 trial indicate successful delivery of estradiol and progesterone, with significant improvements in VMS and vaginal symptoms reported. The company plans to file a new drug application under the FDA’s 505(b)(2) pathway, with a focus on FDA approval for moderate to severe VMS in women with intact uteri.