Dare Bioscience Inc Stock Price, News & Analysis

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.

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.