Daré Bioscience and Rosy Wellness Announce Strategic Collaboration to Educate and Market Daré’s DARE to PLAY Sildenafil Cream

Rhea-AI Summary

Daré Bioscience (NASDAQ: DARE) has announced a strategic partnership with Rosy Wellness to support the marketing and awareness campaign for DARE to PLAY Sildenafil Cream, a topical formulation of sildenafil citrate (Viagra's active ingredient) for female sexual arousal. The product is expected to be available by prescription in Q4 2025 as a compounded drug. Rosy Wellness, with its 250,000+ women community and endorsement from 8,000+ healthcare professionals, will leverage its digital platform to provide educational outreach and healthcare provider engagement. The collaboration aims to destigmatize female sexual health discussions, with data showing 65% of women in Rosy's community reporting arousal concerns. Daré expects to begin recording revenue in Q4 2025 through this partnership that combines Daré's clinical expertise with Rosy's digital reach and engagement model.

Positive

• Partnership with Rosy Wellness provides access to a large established community of 250,000+ women
• Expected revenue generation to begin in Q4 2025
• Strong healthcare professional network with 8,000+ recommendations for Rosy platform
• Large target market potential with 65% of surveyed women reporting arousal concerns

Negative

• Product will only be available as a compounded drug under Section 503B, not as an FDA-approved product
• Market entry not until Q4 2025

Insights

Pharmaceutical Industry Analyst

Daré's partnership with Rosy Wellness creates direct access to target consumers for its upcoming sexual health product, with revenue expected in Q4 2025.

This strategic collaboration between Daré Bioscience and Rosy Wellness represents a targeted commercialization approach for DARE to PLAY Sildenafil Cream. By partnering with Rosy's digital platform, which has 250,000+ women users and endorsements from 8,000+ healthcare professionals, Daré gains immediate access to a relevant audience with demonstrated interest in sexual wellness. The statistic that 65% of Rosy's questionnaire respondents reported arousal concerns confirms a substantial target market within this community.

The regulatory strategy here is particularly noteworthy. By launching as a compounded drug under Section 503B of the FDCA, Daré can bring their product to market in Q4 2025 without completing the lengthy traditional FDA approval process. This compounding pathway typically offers faster commercialization but with less exclusivity protection than FDA-approved drugs. For investors, this means earlier revenue generation but potentially more competitive pressure in the longer term.

Female sexual health remains significantly underserved in the pharmaceutical market. Using sildenafil citrate (Viagra's active ingredient) in a female-specific topical formulation represents a scientifically logical approach to addressing arousal issues by increasing local blood flow to genital tissues. The partnership's focus on education and destigmatization through Rosy's platform addresses a critical barrier in women's sexual health market - the hesitancy to discuss these issues openly - which could accelerate adoption rates.

This collaboration demonstrates tangible progress in Daré's commercialization strategy, establishing a clear timeline for market entry and revenue generation in an underserved therapeutic area.

Collaboration will leverage Rosy Wellness’ extensive reach and community of over 250,000 women

Rosy Wellness is a multi-award winning app recommended by 8,000+ healthcare professionals

Daré expects to start recording revenue in the 4th quarter this year

SAN DIEGO, June 04, 2025 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority, and Rosy Wellness, a pioneering digital platform focused on providing lifespan support for women, today announced a strategic collaboration to support the upcoming marketing and consumer and healthcare provider awareness campaign for Daré’s DARE to PLAY Sildenafil Cream.

Daré’s DARE to PLAY Sildenafil Cream is a proprietary topical formulation of sildenafil citrate, the same active ingredient in Viagra^®, developed specifically to increase blood flow locally to genital tissues, which is part of the sexual arousal response in women. The company is targeting availability by prescription in the United States in the 4^th quarter 2025 as a compounded drug under Section 503B of the FDCA.

This partnership brings together Daré’s clinical expertise and innovation in women's health with Rosy’s digital reach and content-driven community engagement model, which includes a community of 250K+ women. Concerns with arousal were reported by 65% of those women who completed the Female Sexual Function Index screener questionnaire. The collaboration will center on educational outreach, consumer and healthcare provider engagement, and companion digital support to destigmatize conversations around female sexual health and promote awareness of DARE to PLAY Sildenafil Cream, helping women regain intimacy and satisfaction in their lives.

“Female sexual health remains significantly underserved, and we believe our DARE to PLAY Sildenafil Cream represents a meaningful advancement,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “Partnering with Rosy allows us to connect with women in a trusted, authentic space that encourages open discussion and education about sexual wellness.”

Rosy, known for its innovative and evidence-based approach to women’s sexual health through education, CBT-based (Cognitive Behavioral Therapy) exercises, expert-led health coaching, and community support, will support the launch with a comprehensive digital strategy including educational campaigns, and a companion care platform aimed at increasing understanding of female sexual health and supporting DARE to PLAY Sildenafil Cream’s users throughout their journey.      

“At Rosy, we’re committed to closing gaps in women’s healthcare with evidence-based, accessible solutions,” said Lyndsey Harper, MD, Founder and CEO of Rosy. “This partnership with Daré accelerates our efforts to bring much needed attention and resources to sexual wellness, a historically stigmatized area. Together, we can expand sexual wellness education, access, and support for women."     

The partnership underscores a shared commitment to advancing sexual health equity and ensuring women have access to both the information and solutions they need.

For more information, please visit www.darebioscience.com and www.meetrosy.com.

About Rosy Wellness     

Rosy is a leading women's health platform dedicated to empowering women with evidence-based resources, expert support, and community connection, starting with sexual health and expanding across the full spectrum of the health of women. Founded by Lyndsey Harper, a board-certified OB-GYN, Rosy addresses long-overlooked aspects of women's care through an accessible digital platform that combines personalized education, self-guided tools, community, and health coaching.

Whether tackling issues like sexual dysfunction, menopause, migraine, or emotional well-being, Rosy provides judgment-free, medically backed support designed for real life. By combining evidence-based support with user-friendly technology, Rosy is redefining how women take charge of their health and experience more fulfilling lives.     

About Daré Bioscience

Daré Bioscience is a biopharmaceutical company driven by a mission to challenge the status quo, making women's health a priority. Daré believes that innovation does not have to start from scratch. The company’s goal is to bring to market as soon as practicable innovative evidence-based solutions that address decades of unmet needs in women’s health and enhance outcomes and convenience, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious disease, vaginal health and menopause. The potential products Daré identifies, in many cases, already have clinical proof of concept or existing safety data for the active ingredient that the company leverages. This provides optionality and flexibility, in many cases, in how Daré seeks to bring solutions to market in ways designed to optimize access for women in a fiscally responsible manner.

The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil citrate, the active ingredient in an oral erectile dysfunction drug for men, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com.

Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma and Daré's CEO has been honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space.

Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.

Forward-Looking Statements

Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s go-to-market strategies; Daré’s plans and timing for making its proprietary formulation of sildenafil citrate available by prescription in the U.S. as a compounded drug via Section 503B of Federal Food, Drug, and Cosmetic Act (FDCA); the market opportunity for the product and its ability to gain market acceptance; expected timing of revenue from sales; the potential benefits of Daré’s collaboration with Rosy Wellness; and Daré’s development plans for the investigational products in its portfolio and their respective potential to complete clinical development and obtain regulatory approval. As used in this press release, “first-in-category” is a forward-looking statement relating to the potential of a product candidate to represent a new category of product if it were to receive marketing approval for the indication for which it is being developed because Daré believes it would address a need in women’s health that is not being met by existing U.S. Food and Drug Administration (FDA)-approved products. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to execute its business strategy and continue as a going concern; the risk of delisting of Daré’s common stock from Nasdaq; the effects of macroeconomic conditions, geopolitical events, and major changes and disruptions in U.S. government policies and operations on Daré’s ability to raise additional capital or on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; Daré’s ability to enter into and maintain third-party collaborations to facilitate access to the solutions Daré intends to bring to market as compounded drugs or consumer health products and Daré’s reliance on those third parties; the performance of Section 503B-registered outsourcing facilities and other third parties on which Daré will rely to execute its expanded business strategy; the risk that the FDA could stop permitting Section 503B-registered outsourcing facilities to compound the drug substances in the proprietary formulations Daré intends to bring or brings to market; the degree of market demand and acceptance for the products Daré brings to market; Daré’s reliance on third parties to manufacture and conduct clinical trials and preclinical studies of its product candidates and commercialize XACIATO™ (clindamycin phosphate) vaginal gel 2% and future products, if any; the risk that the current regulatory pathway known as the FDA’s 505(b)(2) pathway for drug product approval in the U.S. is not available for a product candidate as Daré anticipates; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its subaward and grant agreements; the potential for termination of the subaward and grant agreements before Daré receives additional payments; the limits on Daré’s ability to sell stock under its equity line arrangement at times it may desire to raise additional capital; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate and the inherent uncertainty of outcomes of clinical trials; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risks that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate and that interim data or results from a particular clinical study do not necessarily predict the final results for that study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage, pricing and reimbursement from third-party payors; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s products or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Contacts:

Daré Bioscience Investor Relations
innovations@darebioscience.com

Source: Daré Bioscience, Inc.

FAQ

When will DARE to PLAY Sildenafil Cream be available in the market?

DARE to PLAY Sildenafil Cream is expected to be available by prescription in the United States in the fourth quarter of 2025.

What is the purpose of Daré Bioscience's partnership with Rosy Wellness?

The partnership aims to support marketing, consumer awareness, and healthcare provider engagement for DARE to PLAY Sildenafil Cream through Rosy's digital platform and community of 250,000+ women.

How many healthcare professionals recommend Rosy Wellness?

Rosy Wellness is recommended by over 8,000 healthcare professionals.

What is DARE to PLAY Sildenafil Cream used for?

It is a topical formulation of sildenafil citrate designed to increase blood flow to genital tissues as part of the sexual arousal response in women.

When does Daré Bioscience (DARE) expect to start generating revenue from this product?

Daré Bioscience expects to start recording revenue in the fourth quarter of 2025.