Daré Bioscience Receives FDA Clearance for HPV Treatment Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 3 days ago
0mins
Should l Buy DARE?
Source: Newsfilter
- FDA Clearance Milestone: Daré Bioscience's DARE-HPV has received IND approval from the FDA, allowing the company to initiate a planned Phase 2 clinical study aimed at evaluating the drug as a potential treatment for persistent high-risk HPV infection, addressing a significant gap in women's health treatment options.
- Innovative Treatment Approach: DARE-HPV is a non-surgical, localized self-administered therapy designed to target the HPV virus directly, potentially transforming the current monitoring-focused treatment paradigm and alleviating the economic and psychological burdens on women during the waiting period for the virus to clear.
- Funding Support and Market Need: The program is backed by a $10 million contract from the Advanced Research Projects Agency for Health (ARPA-H), with $6.5 million received to date, highlighting the emphasis on and investment potential in women's health.
- Clinical Study Outlook: The planned Phase 2 study will assess the safety and antiviral activity of DARE-HPV, and if successful, it will provide women with new treatment options, significantly changing the management of high-risk HPV infections and carrying important social and economic implications.
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Analyst Views on DARE
Wall Street analysts forecast DARE stock price to rise
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 1.720
Low
8.00
Averages
10.00
High
12.00
Current: 1.720
Low
8.00
Averages
10.00
High
12.00
About DARE
Dare Bioscience, Inc. is a biopharmaceutical company. The Company's programs target unmet needs in women's health, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. Its product includes XACIATO (clindamycin phosphate) vaginal gel 2%. XACIATO is a single-dose prescription medication for the treatment of bacterial vaginosis in females 12 years of age and older. Its other product candidates include Ovaprene, Sildenafil Cream, and DARE-HRT1. Ovaprene is an investigational, hormone-free, monthly intravaginal contraceptive. Sildenafil Cream is a novel cream formulation of sildenafil for the treatment of female sexual arousal disorder; and DARE-HRT1 is an intravaginal ring designed to deliver a combination of menopausal hormone therapy, bio-identical 17b-estradiol and progesterone together, continuously over a 28-day period for the treatment of moderate to severe vasomotor symptoms, also known as hot flashes.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Daré Bioscience Receives FDA Clearance for HPV Treatment Study
- FDA Clearance Milestone: Daré Bioscience's DARE-HPV has received IND approval from the FDA, allowing the company to initiate a planned Phase 2 clinical study aimed at evaluating the drug as a potential treatment for persistent high-risk HPV infection, addressing a significant gap in women's health treatment options.
- Innovative Treatment Approach: DARE-HPV is a non-surgical, localized self-administered therapy designed to target the HPV virus directly, potentially transforming the current monitoring-focused treatment paradigm and alleviating the economic and psychological burdens on women during the waiting period for the virus to clear.
- Funding Support and Market Need: The program is backed by a $10 million contract from the Advanced Research Projects Agency for Health (ARPA-H), with $6.5 million received to date, highlighting the emphasis on and investment potential in women's health.
- Clinical Study Outlook: The planned Phase 2 study will assess the safety and antiviral activity of DARE-HPV, and if successful, it will provide women with new treatment options, significantly changing the management of high-risk HPV infections and carrying important social and economic implications.
See More
Atossa Therapeutics Receives FDA Orphan Drug Designation, Stock Rises Nearly 13%
- FDA Orphan Drug Designation: Atossa Therapeutics (ATOS) announced that its (Z)-endoxifen received Orphan Drug Designation from the FDA, leading to a 12.98% stock increase to $0.69, marking a significant milestone in the treatment of Duchenne muscular dystrophy and expected to drive future R&D progress.
- Clinical Trial Progress: ImmunityBio (IBRX) reported that over 85% of the study population has been enrolled in its registrational trial QUILT-2.005 for BCG-naïve non-muscle-invasive bladder cancer, with stock rising 9.43% to $6.04, and full enrollment anticipated by Q2 2026, enhancing market confidence.
- NASDAQ Compliance Extension: Femasys (FEMY) received NASDAQ approval for a 180-day extension to meet the minimum $1.00 bid price requirement, with stock climbing 10.68% to $0.72, providing the company until July 13, 2026, to regain compliance, alleviating investor concerns.
- Successful Financing: Foghorn Therapeutics (FHTX) closed a $50 million registered direct financing at a 30% premium, resulting in a 4.02% stock increase to $6.26, demonstrating market confidence and support for its future development.
See More
Daré Bioscience Launches DARE to PLAY™ Sildenafil Cream for Women, Effective in 10-15 Minutes
- Breakthrough in Women's Health: Daré Bioscience's DARE to PLAY™ Sildenafil Cream is the first topical arousal product specifically designed for women, clinically shown to significantly increase genital blood flow within 10-15 minutes, addressing a long-standing gap in women's sexual health.
- Market Opportunity: With approximately 20 million women in the U.S. facing genital arousal challenges and no FDA-approved therapeutics available, the launch of DARE to PLAY™ provides a scientifically-backed solution for this large, underserved market, presenting significant commercial potential.
- Clinical Validation: The product has undergone multiple clinical trials, including a randomized placebo-controlled study involving 200 women and their partners, ensuring its safety and efficacy, marking a significant advancement in the field of women's sexual health.
- Manufacturing Compliance: DARE to PLAY™ is produced through a 503B outsourcing facility, adhering to current Good Manufacturing Practice (cGMP) regulations, ensuring product quality and consistency, thus providing women with a reliable health option.
See More
Daré Bioscience Launches DARE to PLAY™ Sildenafil Cream for Women, Effective in 10-15 Minutes
- Breakthrough in Women's Health: Daré Bioscience's DARE to PLAY™ Sildenafil Cream is the first topical product specifically designed for women, clinically shown to increase genital blood flow within 10-15 minutes, addressing a long-standing gap in women's sexual health.
- Market Opportunity: With approximately 20 million women in the U.S. experiencing genital arousal issues and no FDA-approved therapeutics available, the launch of DARE to PLAY™ provides a clinically evidence-backed solution for this large, underserved market, presenting significant commercial potential.
- Clinical Support: The product is backed by multiple clinical trials, including a randomized placebo-controlled study involving 200 women and their partners, ensuring its safety and efficacy, marking a scientific advancement in women's sexual health products.
- Manufacturing Compliance: DARE to PLAY™ is produced through a 503B outsourcing facility compliant with cGMP standards, ensuring product quality and consistency while providing women with a safe and effective option to take charge of their sexual health.
See More
Daré Bioscience Regains Ovaprene® Rights, Advancing Women's Health Innovation
- Consolidation of Rights: Daré Bioscience announced the return of commercialization rights for Ovaprene®, enhancing the company's strategic position in women's health, effective February 2026, marking full control over this critical asset.
- Clinical Trial Progress: The Phase 3 clinical trial for Ovaprene is underway, supported by non-dilutive funding, with positive interim data indicating favorable safety and tolerability, positioning it to potentially become the first FDA-approved hormone-free monthly intravaginal contraceptive.
- Market Potential: As an innovative non-hormonal contraceptive option, Ovaprene addresses a significant gap in women's health, expected to attract broad strategic interest from pharmaceutical and consumer health organizations, further driving company growth.
- Increased Strategic Flexibility: By consolidating global commercialization rights, Daré can explore the most attractive commercial and access pathways, including partnerships and non-traditional commercialization models, maximizing long-term economic benefits.
See More
Daré Bioscience (DARE) Third Quarter 2025 Earnings Call Transcript
- Author's Perspective: The views and opinions presented are solely those of the author.
- No Official Endorsement: The content does not necessarily reflect the views of Nasdaq, Inc.
See More
Daré Bioscience Receives FDA Clearance for HPV Treatment Study
- FDA Clearance Milestone: Daré Bioscience's DARE-HPV has received IND approval from the FDA, allowing the company to initiate a planned Phase 2 clinical study aimed at evaluating the drug as a potential treatment for persistent high-risk HPV infection, addressing a significant gap in women's health treatment options.
- Innovative Treatment Approach: DARE-HPV is a non-surgical, localized self-administered therapy designed to target the HPV virus directly, potentially transforming the current monitoring-focused treatment paradigm and alleviating the economic and psychological burdens on women during the waiting period for the virus to clear.
- Funding Support and Market Need: The program is backed by a $10 million contract from the Advanced Research Projects Agency for Health (ARPA-H), with $6.5 million received to date, highlighting the emphasis on and investment potential in women's health.
- Clinical Study Outlook: The planned Phase 2 study will assess the safety and antiviral activity of DARE-HPV, and if successful, it will provide women with new treatment options, significantly changing the management of high-risk HPV infections and carrying important social and economic implications.
See More
Atossa Therapeutics Receives FDA Orphan Drug Designation, Stock Rises Nearly 13%
- FDA Orphan Drug Designation: Atossa Therapeutics (ATOS) announced that its (Z)-endoxifen received Orphan Drug Designation from the FDA, leading to a 12.98% stock increase to $0.69, marking a significant milestone in the treatment of Duchenne muscular dystrophy and expected to drive future R&D progress.
- Clinical Trial Progress: ImmunityBio (IBRX) reported that over 85% of the study population has been enrolled in its registrational trial QUILT-2.005 for BCG-naïve non-muscle-invasive bladder cancer, with stock rising 9.43% to $6.04, and full enrollment anticipated by Q2 2026, enhancing market confidence.
- NASDAQ Compliance Extension: Femasys (FEMY) received NASDAQ approval for a 180-day extension to meet the minimum $1.00 bid price requirement, with stock climbing 10.68% to $0.72, providing the company until July 13, 2026, to regain compliance, alleviating investor concerns.
- Successful Financing: Foghorn Therapeutics (FHTX) closed a $50 million registered direct financing at a 30% premium, resulting in a 4.02% stock increase to $6.26, demonstrating market confidence and support for its future development.
See More
Daré Bioscience Launches DARE to PLAY™ Sildenafil Cream for Women, Effective in 10-15 Minutes
- Breakthrough in Women's Health: Daré Bioscience's DARE to PLAY™ Sildenafil Cream is the first topical arousal product specifically designed for women, clinically shown to significantly increase genital blood flow within 10-15 minutes, addressing a long-standing gap in women's sexual health.
- Market Opportunity: With approximately 20 million women in the U.S. facing genital arousal challenges and no FDA-approved therapeutics available, the launch of DARE to PLAY™ provides a scientifically-backed solution for this large, underserved market, presenting significant commercial potential.
- Clinical Validation: The product has undergone multiple clinical trials, including a randomized placebo-controlled study involving 200 women and their partners, ensuring its safety and efficacy, marking a significant advancement in the field of women's sexual health.
- Manufacturing Compliance: DARE to PLAY™ is produced through a 503B outsourcing facility, adhering to current Good Manufacturing Practice (cGMP) regulations, ensuring product quality and consistency, thus providing women with a reliable health option.
See More
Daré Bioscience Launches DARE to PLAY™ Sildenafil Cream for Women, Effective in 10-15 Minutes
- Breakthrough in Women's Health: Daré Bioscience's DARE to PLAY™ Sildenafil Cream is the first topical product specifically designed for women, clinically shown to increase genital blood flow within 10-15 minutes, addressing a long-standing gap in women's sexual health.
- Market Opportunity: With approximately 20 million women in the U.S. experiencing genital arousal issues and no FDA-approved therapeutics available, the launch of DARE to PLAY™ provides a clinically evidence-backed solution for this large, underserved market, presenting significant commercial potential.
- Clinical Support: The product is backed by multiple clinical trials, including a randomized placebo-controlled study involving 200 women and their partners, ensuring its safety and efficacy, marking a scientific advancement in women's sexual health products.
- Manufacturing Compliance: DARE to PLAY™ is produced through a 503B outsourcing facility compliant with cGMP standards, ensuring product quality and consistency while providing women with a safe and effective option to take charge of their sexual health.
See More
Daré Bioscience Regains Ovaprene® Rights, Advancing Women's Health Innovation
- Consolidation of Rights: Daré Bioscience announced the return of commercialization rights for Ovaprene®, enhancing the company's strategic position in women's health, effective February 2026, marking full control over this critical asset.
- Clinical Trial Progress: The Phase 3 clinical trial for Ovaprene is underway, supported by non-dilutive funding, with positive interim data indicating favorable safety and tolerability, positioning it to potentially become the first FDA-approved hormone-free monthly intravaginal contraceptive.
- Market Potential: As an innovative non-hormonal contraceptive option, Ovaprene addresses a significant gap in women's health, expected to attract broad strategic interest from pharmaceutical and consumer health organizations, further driving company growth.
- Increased Strategic Flexibility: By consolidating global commercialization rights, Daré can explore the most attractive commercial and access pathways, including partnerships and non-traditional commercialization models, maximizing long-term economic benefits.
See More
Daré Bioscience (DARE) Third Quarter 2025 Earnings Call Transcript
- Author's Perspective: The views and opinions presented are solely those of the author.
- No Official Endorsement: The content does not necessarily reflect the views of Nasdaq, Inc.
See More
