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Daré Bioscience Reports Second Quarter 2020 Financial Results and Provides Company Update
Conference Call Today at 4:30 p.m. Eastern Time SAN DIEGO, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Conference Call Today at 4:30 p.m. Eastern Time\nSAN DIEGO, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the second quarter ended June 30, 2020 and provided a company update.\n “During the second quarter, we continued to execute on key strategic and operational objectives, despite the challenges presented by the COVID-19 pandemic,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Importantly, we initiated the DARE-BVFREE pivotal study for DARE-BV1 in June. Given the anticipated short duration of the study, we expect to report topline data from the study by year-end 2020. Positive results from this single pivotal study will enable us to submit a new drug application for DARE-BV1 with the FDA in early 2021, two years from licensing the technology.” Daré licensed the rights to DARE-BV1 and the underlying hydrogel technology at the end of 2018. The company applied for and obtained a qualified infectious disease product (QIDP) designation from the U.S. Food and Drug Administration (FDA) for DARE-BV1 in 2019, making DARE-BV1 eligible for a 5-year marketing exclusivity extension for the treatment of bacterial vaginosis in women upon approval. Daré also received Fast Track designation for DARE-BV1 for the treatment of bacterial vaginosis, which is granted by the FDA for drugs that are intended for the treatment of serious or life-threatening diseases or conditions and demonstrate the potential to address an unmet medical need. The designation offers the opportunity for more frequent interactions with the FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support FDA approval. The Fast Track program is intended to facilitate development and expedite review of a Fast Track drug so that an approved product can reach the market expeditiously. “The DARE-BVFREE study represents the first of a series of important upcoming milestones for our clinical-stage product candidates that are integral to our value creation strategy,” said William Rastetter, PhD, Chairman of Daré’s Board of Directors. “In addition to anticipating the topline data readout for our Phase 3 study of DARE-BV1 in 2020, in 2021, we expect to report topline data from our planned Phase 2b study of Sildenafil Cream ...