Daré Bioscience(US:DARE) Globenewswire·2026-02-23 13:00Core Viewpoint - Daré Bioscience has received FDA clearance for its investigational drug DARE-HPV, which aims to treat persistent high-risk HPV infections, marking a significant advancement in women's health as there are currently no FDA-approved pharmacologic treatments for HPV [1][5][8] Company Overview - Daré Bioscience is a health biotech company focused on addressing gaps in women's health through innovative solutions backed by rigorous research [9][10] - The company aims to provide evidence-based therapies for various women's health issues, including HPV infections, which have historically lacked effective treatment options [10] Product Development - DARE-HPV is a non-surgical, localized, self-administered therapy designed to clear persistent high-risk HPV infections, which are responsible for nearly all cervical cancer cases in the U.S. [2][3][8] - The drug targets the virus directly, potentially redefining the treatment paradigm for cervical disease prevention by intervening before precancerous changes occur [2][5] Clinical Study and Funding - The planned Phase 2 clinical study will evaluate the safety and antiviral activity of DARE-HPV in women with persistent high-risk HPV infection, supported by a $10 million contract from the Advanced Research Projects Agency for Health (ARPA-H) [5][6] - The company has received $6.5 million of the funding to date and is preparing to initiate the study in 2026 [5][6] Market Need - Persistent high-risk HPV infection represents a substantial unmet medical need, as current standard care involves monitoring without treating the virus, leading to significant physical and emotional burdens for women [4][6] - The lack of effective treatments has resulted in women being subjected to costly and burdensome "watchful waiting" visits, contributing to disparities in cervical cancer outcomes [5][6]