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News about Daré Bioscience, Inc. (NASDAQ: DARE) centers on its efforts to advance and commercialize women’s health products across contraception, sexual health, vaginal health and menopause. Company press releases highlight progress on clinical programs, grant-funded research, regulatory interactions and commercialization plans for both prescription and consumer health offerings.
Recent news has focused on DARE to PLAY Sildenafil Cream, a proprietary topical arousal cream designed specifically for women. Daré reports that this first-of-its-kind topical sildenafil formulation for women has been evaluated in multiple clinical studies and is being introduced via a Section 503B outsourcing facility as an evidence-backed option to enhance genital blood flow and arousal response. Updates describe pre-order availability in select U.S. states, webinar events with sexual health clinicians and the role of DARE to PLAY in the company’s broader 503B compounding strategy.
Another major news theme is Ovaprene, Daré’s investigational hormone-free monthly intravaginal contraceptive. Releases discuss interim Phase 3 results, data safety monitoring board recommendations to continue the pivotal study without modification, and the return of commercialization rights to Daré from a prior license partner. These items provide context on clinical progress, safety and tolerability findings, and the company’s plans to maximize the asset’s value.
Daré’s news flow also covers non-dilutive grant funding and collaborations, including multi-year support for DARE-LARC1, a long-acting contraceptive based on the DARE-IDDS programmable drug delivery platform, and grants for non-hormonal intravaginal contraceptive research and HPV-related programs. Corporate updates detail quarterly financial results, Nasdaq listing matters, and strategic initiatives that combine near-term revenue opportunities with long-term pipeline development. Investors and observers can use the DARE news page to follow these developments and track how clinical, commercial and funding milestones evolve over time.
Dare Bioscience (NASDAQ: DARE) launched nationwide telehealth consultations for DARE to PLAY™ Sildenafil Cream, a clinically studied topical arousal cream for women shown to increase genital blood flow in 10–15 minutes and improve arousal on validated endpoints. Pre-fulfillment prescribing is available in all 50 states with prescriptions held until pharmacy dispensing begins via a 503B outsourcing facility. Early access benefits include a complimentary telehealth visit during pre-fulfillment, 25% off initial order and refills, and priority fulfillment once dispensing starts.
Dare Bioscience (NASDAQ: DARE) announced pre-orders by prescription for DARE to PLAY™ Sildenafil Cream beginning Dec 10, 2025, with commercial rollout through a 503B outsourcing facility.
The topical sildenafil cream is described as the first evidence-backed formulation for women, supported by toxicology studies, multiple clinical trials including a randomized placebo-controlled study of 200 women, and peer-reviewed publications. Prescriptions can be filled in CT, FL, IN, MO, NH, NJ, OR, PA, RI, and UT and will ship within 45 days during the pre-order phase. The product is a compounded 503B drug and is not FDA approved.
Daré Bioscience (NASDAQ: DARE) announced Bayer will return all rights to Ovaprene after Bayer elected to terminate the license; termination is effective February 2026. Daré will hold consolidated global commercialization rights for the late-stage, first-in-category, hormone-free monthly intravaginal contraceptive while its pivotal Phase 3 trial continues.
Key facts: positive interim Phase 3 data reported in July 2025 showing consistent safety and tolerability and pregnancy rates aligned with pre-pivotal results; enrollment is expected to complete in 2026; the trial continues with non-dilutive grant funding, including a Gates Foundation award announced in 2024. Daré plans to evaluate partnership and commercialization options and pursue a PMA strategy with the FDA CDRH.
Daré Bioscience (NASDAQ: DARE) received an additional ~$3.6 million payment under an existing Gates Foundation grant on Nov 24, 2025. The tranche is part of an up-to-approximately $10.7 million grant originally announced in November 2024 and follows an initial ~$5.4 million payment in 2024. Funds will support preclinical work to identify and develop a non-hormonal intravaginal contraceptive for low- and middle-income country settings and activities on product design, formulation, acceptability, and early-stage development. In parallel, initial grant funding continues to support enrollment in the pivotal Phase 3 trial of Ovaprene (ClinicalTrials.gov ID: NCT06127199). Future payments depend on achievement of specified milestones.
Daré Bioscience (NASDAQ: DARE) reported Q3 2025 results and a corporate update announcing near-term commercialization plans and continued clinical progress.
Key points: DARE to PLAY™ Sildenafil Cream on track for initial prescription fulfillment in December via a 503B outsourcing facility; Ovaprene® Phase 3 received a positive interim DSMB recommendation and enrollment continues; multiple grant-funded programs advanced (DARE-HPV, DARE-LARC1, DARE-NHC) with recent grant installments totaling $10 million and an anticipated $3.6 million installment in November 2025. Financials: $23.1M cash, $3.8M working capital, Q3 G&A $2.5M, R&D $1.2M.
Daré Bioscience (NASDAQ: DARE) will host a live webinar on November 17, 2025 to review clinical data and commercial launch readiness for DARE to PLAY™ Sildenafil Cream, a first-of-its-kind topical sildenafil formulation for women. Clinical results cited show increased genital blood flow within 10–15 minutes of application and improvements in arousal on clinically validated, FDA-reviewed endpoints. The company said commercial availability is anticipated via a 503B outsourcing facility, expected before year-end, and webinar attendees can join a product alert list to be notified when the prescription product becomes available.
Daré Bioscience (NASDAQ: DARE) will host a third quarter 2025 financial results conference call and live webcast on Thursday, November 13, 2025 at 4:30 p.m. ET to review results for the quarter ended September 30, 2025 and provide a company update.
Participants can join by phone at (646) 307-1963 or (800) 715-9871 (toll-free) with conference ID 5794075. The live webcast is available in the Investors > Presentations, Events & Webcasts section at http://ir.darebioscience.com. The webcast archive will be available for replay through November 27, 2025. Attendees are advised to log in 5-10 minutes early to register and install any required software.
Daré Bioscience (NASDAQ: DARE) announced on November 3, 2025 that it has a contract with the Gates Foundation to receive up to $300,000 to conduct a global strategic landscape assessment of organizations with capabilities relevant to contraceptive product development.
Under the contract Daré will identify and assess for-profit and non-profit organizations worldwide with demonstrated capabilities in formulation development, clinical and commercial manufacturing, clinical trial design, and regulatory support for contraceptive products. The project is presented as part of Daré’s effort to strengthen the contraceptive innovation ecosystem and identify potential strategic partners to accelerate product translation.
Daré Bioscience (NASDAQ: DARE) received a $4.0 million non-dilutive grant installment on Oct 6, 2025 for DARE-LARC1, the contraception use case of its programmable DARE-IDDS implantable drug-delivery platform. Total grant funding received is approximately $41.8 million of an up-to-approximately $49 million commitment, with up to $7.1 million remaining contingent on milestones. DARE-LARC1 is preclinical and uses levonorgestrel; the platform is described as capable of programmable, wireless dosing and is being explored for obesity, diabetes, and other chronic conditions. Daré is pursuing strategic partnerships and IND-enabling studies toward an FDA IND submission.
Daré Bioscience (NASDAQ: DARE) has secured a grant of up to $499,000 from the Gates Foundation to support preeclampsia research initiatives. The company will provide strategic mentorship and project management support to Grand Challenges grantee organizations worldwide, focusing on prevention, diagnosis, and treatment of preeclampsia.
The multi-year engagement aims to advance research addressing this critical maternal health condition that claims approximately 76,000 maternal and 500,000 infant lives annually. Currently, there are no FDA-approved treatments for preeclampsia, making this initiative particularly significant for advancing women's health solutions.
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