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Daré Bioscience, Inc. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company focused on the advancement of innovative products for women's reproductive health. The company's mission is to identify, develop, and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes, and facilitate convenience for women. Initially, the company's focus is on contraception, vaginal health, and fertility.
Daré's portfolio includes several product candidates in advanced clinical development. Their lead product, Ovaprene, is a non-hormonal monthly contraceptive ring currently undergoing clinical studies. The company's first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), is a prescription gel for treating bacterial vaginosis in females aged 12 and older. Another prominent product candidate is Sildenafil Cream, 3.6%, a novel formulation intended to treat female sexual arousal disorder (FSAD).
Daré Bioscience has also engaged in significant partnerships to further its mission. For instance, the U.S. commercial rights for Ovaprene are licensed to Bayer, while XACIATO is under a global license agreement with Organon. This collaborative approach has enabled Daré to harness the clinical and market expertise of its partners while retaining control over development and regulatory approval processes.
Recently, Daré has aligned with the FDA on key elements of the Phase 3 program for Sildenafil Cream, setting the stage for a pivotal study to support a New Drug Application (NDA) filing. The company has also received grants, such as the $750,000 from the Bill & Melinda Gates Foundation, to support the development of bacteria-based biotherapeutic products. In addition, Daré is progressing with the clinical development of its hormonal therapy candidate, DARE-HRT1, a bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy.
Daré continues to build on its achievements from 2023, advancing its portfolio of novel investigational therapies, particularly those demonstrating proof of concept. The company actively engages in strategic processes to explore partnering opportunities for additional indications, such as GLP-1s for obesity and metabolic disorders.
Moreover, Daré received a $1 million payment as the latest installment under a grant agreement to advance its investigational contraceptive, DARE-LARC1. This product aims to address specific individual family planning goals with features like precision dosing and wireless control.
For the latest news and updates, investors and interested parties can visit Daré's investor relations website and follow their social media channels. The company remains committed to distributing material information through these channels and encourages stakeholders to stay informed about their developments and milestones.
Daré Bioscience (NASDAQ: DARE) will feature its President and CEO, Sabrina Martucci Johnson, at the Virtual Global Healthcare Conference from September 27 to 30, 2021. Johnson's presentation is scheduled for September 30 at 12:40 p.m. ET. Investors can access a live webcast at this link, with an archived version available until October 15, 2021, on the company's investor website. Daré is known for its commitment to advancing innovative women’s health products, including Ovaprene® and Sildenafil Cream, 3.6%.
Daré Bioscience, Inc. (NASDAQ: DARE) announced that its President and CEO, Sabrina Martucci Johnson, will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13 at 7:00 a.m. ET. An archived version will be accessible until September 29, 2021. Daré specializes in women’s health and is developing innovative therapies, including Ovaprene®, Sildenafil Cream, DARE-BV1, and DARE-HRT1. More information can be found on their website.
Daré Bioscience (NASDAQ: DARE) announces its participation in the Women’s Health Innovation Summit in Boston on September 14-15, 2021. The panel will focus on optimizing study enrollment during the COVID-19 pandemic, specifically discussing the DARE-BVFREE Phase 3 study of DARE-BV1, an investigational treatment for bacterial vaginosis. The study, initiated in 2020, successfully enrolled 307 women and met its primary endpoint, showing clinical cure rates of 70-81%, significantly higher than current FDA-approved treatments. A new drug application for DARE-BV1 has been submitted to the FDA, with a review date set for December 7, 2021.
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.
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