Welcome to our dedicated page for Dare Bioscience news (Ticker: DARE), a resource for investors and traders seeking the latest updates and insights on Dare Bioscience stock.
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 announces a presentation by Dr. David Friend at the EMAS 13th European Congress on Menopause, from September 8-10, 2021. He will present data from the Phase 1 clinical trial of DARE-HRT1, a novel intravaginal ring delivering bio-identical estradiol and progesterone over 28 days. The results support DARE-HRT1’s potential to be the first FDA-approved hormone therapy for menopause symptoms, potentially transforming treatment options. For more information, visit Daré's Investor Relations.
Daré Bioscience (NASDAQ: DARE) reported strong advancements in women’s health innovation with its Q2 2021 financial results, marking a productive year. The company submitted a New Drug Application for DARE-BV1 and secured Priority Review by the FDA, targeting a PDUFA date of December 7, 2021. Clinical studies are underway for Sildenafil Cream and DARE-HRT1. Financially, cash equivalents increased to $9.1 million, with net cash from financing activities nearing $24.6 million. However, the company reported a comprehensive loss of $9.2 million for Q2 2021, up from $7.1 million YoY.
Daré Bioscience (NASDAQ: DARE) announced that the FDA has accepted its New Drug Application (NDA) for DARE-BV1, a treatment for bacterial vaginosis, granting it Priority Review with a PDUFA date set for December 7, 2021.
The NDA is backed by data from the DARE-BVFREE Phase 3 trial, showing clinical cure rates of 70-81% after a single dose of DARE-BV1. If approved, the company plans a robust market launch in 2022, supported by strategic discussions and commercialization arrangements.
Daré Bioscience (NASDAQ: DARE) announced a conference call on August 12, 2021, at 4:30 PM ET to review its financial results for Q2 2021 and provide an update on company developments. Investors can access the call by dialing (844) 831-3031 for the U.S. or (443) 637-1284 internationally, with conference ID 5286254. The company focuses on women's health, offering innovative solutions like the hormone-free contraceptive Ovaprene and Sildenafil Cream for sexual arousal disorders. To learn more, visit darebioscience.com.
Daré Bioscience presented positive results from the DARE-BVFREE Phase 3 trial for DARE-BV1, targeting bacterial vaginosis in women. The study met its primary endpoint, achieving clinical cure rates between 70-81% with a single vaginal dose. This investigational hydrogel formulation includes clindamycin phosphate 2% and aims to provide a convenient alternative to current treatments. The company submitted a new drug application to the FDA in June 2021 and shared findings at the Controlled Release Society Annual Meeting on July 27, 2021.
Daré Bioscience, Inc. (NASDAQ: DARE) has entered into a Cooperative Research and Development Agreement (CRADA) with the NICHD for the Phase 3 study of Ovaprene®, a hormone-free monthly contraceptive. This collaboration will enable shared funding and expertise in conducting the pivotal study, which is expected to begin in 2022. Daré will contribute $5.5 million towards the study costs and aims to submit an Investigational Device Exemption (IDE) to the FDA in Q4 2021. If approved, Ovaprene could become the first monthly non-hormonal contraceptive for women.
Daré Bioscience (NASDAQ: DARE) announced positive topline results from its Phase 1 clinical trial of DARE-HRT1, a novel intravaginal ring (IVR) delivering bio-identical estradiol and progesterone. The trial demonstrated successful continuous delivery over 28 days, targeting vasomotor symptoms and vaginal issues associated with menopause. This positions DARE-HRT1 to potentially be the first FDA-approved combined hormonal therapy in a monthly format. Encouragingly, the treatment was well-tolerated, with high acceptability among participants.
Daré Bioscience (NASDAQ: DARE) will present at the 2021 BIO Digital virtual event from June 10-11 and 14-18, 2021. CEO Sabrina Martucci Johnson will discuss the company's portfolio of innovative investigational products beginning June 10 at 9 a.m. ET. The presentation will be accessible to registered attendees on-demand. Following the event, a recording will be available on Daré's investor relations website until July 2, 2021. Daré is focused on advancing women's health through unique products, including Ovaprene® and Sildenafil Cream, among others.
Daré Bioscience (NASDAQ: DARE) announced its financial results for Q1 2021, reporting a comprehensive loss of approximately $7.3 million, up from $4.3 million in Q1 2020. The company has $7.7 million in cash and cash equivalents. Daré plans to submit a New Drug Application for DARE-BV1, a treatment for bacterial vaginosis, in Q2 2021. Additionally, the Phase 2b study for Sildenafil Cream, aimed at treating female sexual arousal disorder, has commenced. The company also targets several key milestones for 2021-2022 across its product portfolio.
Daré Bioscience, Inc. (NASDAQ: DARE) will host a conference call and live webcast on May 13, 2021, at 4:30 p.m. ET to discuss its financial results for Q1 2021 and provide updates on the company. Interested participants can join via phone or through a webcast on the company’s investor relations website. Daré is focused on innovating women's health products, including candidates for contraception, sexual arousal disorder, bacterial vaginosis, and hormone therapy for menopause.
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