Dare´ Bioscience Announces Positive End-of-Phase 2 Meeting with FDA on Development of Sildenafil Cream, 3.6% in Female Sexual Arousal Disorder and Provides Company Focus Areas for 2024
Dare Bioscience, Inc. (DARE)
Last dare bioscience, inc. earnings: 8/14 04:01 pm
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US:NASDAQ Investor Relations:
ir.darebioscience.com/investor-relations
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Source: GlobeNewswire
SAN DIEGO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- Dare´ Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, and its collaborator Strategic Science & Technologies, LLC (SST), a Cambridge, MA based novel topical drug delivery company, today announced the successful completion of an end-of-Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA), supporting advancement of Sildenafil Cream, 3.6% (Sildenafil Cream) for the treatment of female sexual arousal disorder (FSAD) to a Phase 3 clinical study. The Company also provided an update on focus areas for 2024. Progressing Towards Sildenafil Cream Phase 3 Pivotal Study The Company and the FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including confirming that: FSAD is acceptable as an indication.The trials can be conducted in a premenopausal FSAD-only population.12-weeks of blinded treatment to assess efficacy may be acceptable, provided that the trial
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DARE
Earnings
- 8/10/23 - Miss
DARE
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- DARE's page on the SEC website