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Daré Bioscience Reports Third Quarter 2021 Financial Results and Provides a Company Update
Significant progress on several key clinical and corporate initiatives with the portfolio during the third quarter, including DARE-BV1 NDA acceptance and
About this update from Dare Bioscience, Inc.
[{"type":"text","content":"Significant progress on several key clinical and corporate initiatives with the portfolio during the third quarter, including DARE-BV1 NDA acceptance and Ovaprene NIH CRADA for the pivotal Phase 3 Actively advancing clinical development and strategic partnerships to maximize value of pipeline candidates Conference Call and Webcast Today at 4:30 p.m. ET SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2021 and provided a company update. “We’ve continued to make significant progress on several key clinical and strategic corporate initiatives with our portfolio during a rather challenging year,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The FDA accepted our NDA for DARE-BV1 for priority review with a PDUFA target date of December 7, 2021, and we entered into a CRADA under which a pivotal Phase 3 clinical study of Ovaprene® will be supported by the NICHD’s Contraceptive Development Program and conducted within its Contraceptive Clinical Trial Network. We also initiated a Phase 1/2 clinical study of DARE-VVA1, our intravaginal tamoxifen program. Additionally, we’re continuing to enroll patients in our Phase 2b RESPOND study of Sildenafil Cream, 3.6%, and are scoping the development strategy for DARE-HRT1 following the positive topline results of our Phase 1 clinical study reported earlier this year. On the heels of the important milestones achieved thus far in 2021, we are gearing up for an eventful next few months, and I look forward to providing updates as we progress further.” 4Q 2021 Key Portfolio Objectives DARE-BV1: PDUFA target action date for the NDA of December 7, 2021DARE-BV1: Announce U.S. commercialization strategyOvaprene®: Submit Investigational Device Exemption (IDE) to the FDA for pivotal clinical study Portfolio Accomplishments and Expectations for 2021 – 2022 DARE-BV1: Daré innovation: Novel, investigational thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% as a first-line, single-administration treatment for bacterial vaginosisNew Drug Application (NDA) accepted for filing and granted priority review by the FDA in 3Q 2021PDUFA target action date of December 7, 2021Announce U.S. commercialization strategy in 4Q 2021Robust m...