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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, a leader in women’s health innovation, will have its President and CEO, Sabrina Martucci Johnson, present at the Stifel 2022 Healthcare Conference on November 15, 2022, at 9:10 a.m. ET. The presentation will be available via live webcast on the company's website and archived until November 29, 2022. Daré is committed to advancing innovative therapies for women’s health, including FDA-approved products like XACIATO and candidates such as Ovaprene and Sildenafil Cream. For more details, visit their investor relations page.
Daré Bioscience (NASDAQ: DARE) will host a conference call on November 10, 2022, at 4:30 p.m. ET to discuss its Q3 2022 financial results and provide company updates. Interested participants can access the call by dialing (800) 715-9871 for U.S. callers or (646) 307-1963 internationally. The call will also be available via a live webcast on Daré's Investor Relations website. The company focuses on women's health innovations, including its first FDA-approved product, XACIATO, for bacterial vaginosis, and several candidates in clinical development.
Daré Bioscience (NASDAQ:DARE) has completed subject screening for its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, a potential treatment for female sexual arousal disorder (FSAD). Approximately 100 out of the expected 160-170 subjects have completed study assessments to date. Topline data is anticipated by 2Q-2023. This study represents a significant milestone as there are currently no FDA-approved therapies for FSAD, and Sildenafil Cream aims to be the first approved treatment for this condition.
Daré Bioscience announced positive topline results from its Phase 1/2 clinical trial of DARE-HRT1, an investigational intravaginal ring designed to deliver continuous hormone therapy for menopausal symptoms. DARE-HRT1 showed statistically significant improvements in vasomotor symptoms and vaginal conditions associated with menopause, with 100% of participants finding it comfortable to use. The innovative IVR technology allows consistent drug release without a membrane. Daré plans to leverage this data for FDA approval through the 505(b)(2) pathway.
Daré Bioscience (NASDAQ: DARE) has received FDA approval for an Investigational Device Exemption (IDE) to initiate a pivotal study for Ovaprene, a hormone-free monthly contraceptive. The single-arm study will assess Ovaprene's efficacy, safety, and usability. Previous trials indicated Ovaprene effectively blocked sperm entry. The FDA's approval validates the company's data and aligns on study duration and design. If successful, this could lead to marketing approval for what may become the first FDA-approved monthly self-administered contraceptive. Study recruitment is targeted for mid-2023.
Daré Bioscience (NASDAQ: DARE) announced CEO Sabrina Martucci Johnson's participation in two upcoming conferences focused on women’s health. The Informa Connect Women’s Healthcare Access & Innovation Digital Conference will take place on September 21, 2022, featuring a presentation on non-hormonal female contraception. The Longwood Healthcare Leaders Fall Webconference is scheduled for September 22, 2022, and will include a panel on innovative partnerships. Daré aims to advance products that enhance women's health.
Daré Bioscience (NASDAQ: DARE) announced that its President and CEO, Sabrina Martucci Johnson, will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference. The event is scheduled from September 12-14, 2022 at the Lotte New York Palace Hotel, with virtual attendance options available.
The chat will start on September 12 at 11:30 AM ET, and can be accessed on-demand through their website until September 26, 2022. Daré is focused on advancing women's health innovations.
Daré Bioscience (NASDAQ: DARE) announced key updates regarding their Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6%, targeting female sexual arousal disorder (FSAD). Enrollment is expected to complete by 4Q-2022, with topline data anticipated in 2Q-2023. This study aims to evaluate the efficacy and safety of the cream compared to a placebo in premenopausal patients. If successful, it could become the first FDA-approved treatment for FSAD, filling a significant market gap as currently no such options exist for women.
Daré Bioscience has announced a licensing agreement with Hennepin Life Sciences, acquiring exclusive global rights to develop and commercialize glycerol monolaurate (GML) for various vaginal infections. GML, a natural antimicrobial, has shown efficacy against significant strains of Candida and Gardnerella vaginalis without promoting antibiotic resistance. The deal includes milestone payments and royalties based on sales, with patents extending to 2040. This initiative advances Daré's mission to enhance women's health options, building on its recent agreement for the XACIATO treatment.
Daré Bioscience (NASDAQ: DARE) reported its financial results for Q2 2022, highlighting a $32.1 million cash position and a $10 million revenue recognition from a licensing agreement with Organon for XACIATO, an FDA-approved treatment for bacterial vaginosis. The company expects to launch XACIATO in the U.S. in Q4 2022. Ongoing clinical studies for DARE-VVA1 and DARE-HRT1 are also on track for topline data in the fourth quarter. General and administrative expenses increased to $2.8 million, while research and development expenses decreased slightly to $6.8 million.