Dare Bioscience, Inc. - DARE STOCK NEWS

Daré Bioscience (NASDAQ: DARE) announced the development of DARE-PDM1, a new product utilizing hydrogel technology for vaginal delivery of diclofenac to treat primary dysmenorrhea. A Phase 1 study is anticipated in 2023, aiming to fill a void in FDA-approved treatments for this condition. The company reported significant progress in 2022, including a licensing agreement with Organon for XACIATO, and several ongoing clinical trials in innovative women's health programs. The global market for dysmenorrhea treatment is projected to grow from USD 11 billion to USD 25 billion by 2028, indicating strong commercial potential.

Daré Bioscience (NASDAQ: DARE) has secured a grant of $584,986 from the Bill & Melinda Gates Foundation to develop a reconstitutable vaginal thermosetting gel for administering live biotherapeutics. This innovative formulation aims to improve vaginal health and could enhance therapeutic availability, especially in diverse climates. The company is addressing the unmet need for products that restore vaginal microbiota post-infection, with the potential to reduce infection recurrence. Daré's first FDA-approved product, XACIATO, is set for commercial sale in early 2023.

Daré Bioscience, Inc. (NASDAQ: DARE) announced positive topline results from its Phase 1/2 clinical study of DARE-VVA1, a novel intravaginal formulation for treating vulvar and vaginal atrophy (VVA) in postmenopausal women, particularly those with hormone receptor-positive breast cancer. The study demonstrated safety and tolerability, with significant improvements in vaginal cytology and bothersome symptoms. DARE-VVA1 could become the first FDA-approved product for VVA in this patient group, addressing a critical unmet need. The study involved 17 participants, with positive outcomes reported across various doses.

Daré Bioscience reported a strong financial position as of September 30, 2022, with $40.4 million in cash. The company received $18 million in non-dilutive cash, bolstering its balance sheet. Key developments include FDA approval for Ovaprene's pivotal study and positive efficacy data for DARE-HRT1. Additionally, subject screening for Sildenafil Cream's Phase 2b RESPOND study has been completed, targeting topline data announcement in Q2 2023. Daré anticipates the first commercial sale of XACIATO in the U.S. in 1H 2023, aimed at addressing bacterial vaginosis affecting 21 million women.

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.