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Daré Bioscience, Inc. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company focused on the advancement of innovative products for women's reproductive health. The company's mission is to identify, develop, and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes, and facilitate convenience for women. Initially, the company's focus is on contraception, vaginal health, and fertility.
Daré's portfolio includes several product candidates in advanced clinical development. Their lead product, Ovaprene, is a non-hormonal monthly contraceptive ring currently undergoing clinical studies. The company's first FDA-approved product, XACIATO (clindamycin phosphate vaginal gel 2%), is a prescription gel for treating bacterial vaginosis in females aged 12 and older. Another prominent product candidate is Sildenafil Cream, 3.6%, a novel formulation intended to treat female sexual arousal disorder (FSAD).
Daré Bioscience has also engaged in significant partnerships to further its mission. For instance, the U.S. commercial rights for Ovaprene are licensed to Bayer, while XACIATO is under a global license agreement with Organon. This collaborative approach has enabled Daré to harness the clinical and market expertise of its partners while retaining control over development and regulatory approval processes.
Recently, Daré has aligned with the FDA on key elements of the Phase 3 program for Sildenafil Cream, setting the stage for a pivotal study to support a New Drug Application (NDA) filing. The company has also received grants, such as the $750,000 from the Bill & Melinda Gates Foundation, to support the development of bacteria-based biotherapeutic products. In addition, Daré is progressing with the clinical development of its hormonal therapy candidate, DARE-HRT1, a bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy.
Daré continues to build on its achievements from 2023, advancing its portfolio of novel investigational therapies, particularly those demonstrating proof of concept. The company actively engages in strategic processes to explore partnering opportunities for additional indications, such as GLP-1s for obesity and metabolic disorders.
Moreover, Daré received a $1 million payment as the latest installment under a grant agreement to advance its investigational contraceptive, DARE-LARC1. This product aims to address specific individual family planning goals with features like precision dosing and wireless control.
For the latest news and updates, investors and interested parties can visit Daré's investor relations website and follow their social media channels. The company remains committed to distributing material information through these channels and encourages stakeholders to stay informed about their developments and milestones.
Daré Bioscience, a leading innovator in women’s health, has announced its participation in several upcoming conferences. Notably, Sabrina Martucci Johnson, CEO, will present at the Cowen 42nd Annual Health Care Conference on March 8, 2022, at 1:30 p.m. ET. Additionally, she will engage in a panel discussion at the Therapeutic Area Partnerships Conference on March 8 and participate in the 34th Annual Roth Conference on March 14. The company focuses on advancing therapies in women's health, with products like XACIATO for bacterial vaginosis.
Daré Bioscience, a leader in women’s health innovation, announced its President and CEO, Sabrina Martucci Johnson, will present at two major conferences: the 2022 BIO CEO & Investor Conference (February 14-17, 2022) and the SVB Leerink Virtual 11th Annual Global Healthcare Conference (February 14-18, 2022). Johnson's in-person presentation at the BIO CEO Conference is scheduled for February 14 at 2:15 p.m. EST, while her SVB Leerink presentation will be on February 17 at 1:00 p.m. EST. Archived webcasts will be available post-event on Daré's website.
Daré Bioscience (NASDAQ: DARE) announced that President and CEO Sabrina Martucci Johnson will present at the H.C. Wainwright BIOCONNECT 2022 Conference, taking place virtually from January 10-13, 2022. Her presentation will be available on-demand starting January 10 at 7:00 a.m. ET, and accessible under the Investors section of the company’s website. A recorded version will be available until January 27, 2022. Daré focuses on innovative women’s health products, including their FDA-approved product XACIATO and various clinical candidates.
On December 7, 2021, Daré Bioscience announced FDA approval for XACIATO (clindamycin phosphate vaginal gel, 2%), marking a significant milestone as it becomes the company's first FDA-approved product targeting bacterial vaginosis in women aged 12 and older. With over 21 million women affected, XACIATO aims to address the high recurrence rate of bacterial vaginosis and improve treatment outcomes. The company is pursuing strategic partnerships for commercialization, with expectations for a U.S. launch in 2022.
Daré Bioscience (NASDAQ: DARE) reported significant progress in Q3 2021, with the FDA accepting the NDA for DARE-BV1, targeting a PDUFA action date of December 7, 2021. The company entered a CRADA for Ovaprene's pivotal Phase 3 study and initiated a Phase 1/2 study for DARE-VVA1. Financially, Daré had cash equivalents of $45.6 million and a comprehensive loss of $12.7 million. R&D expenses rose to $10.4 million, driven by clinical trials. The company anticipates robust market introduction for DARE-BV1 in H1 2022, pending FDA approval.
Daré Bioscience (NASDAQ: DARE) announced that CEO Sabrina Martucci Johnson will present at the Stifel 2021 Virtual Healthcare Conference on November 16, 2021, at 3:20 p.m. ET. A live webcast of the presentation will be available, with an archived version accessible until November 30, 2021. Daré focuses on innovative products for women's health, with a portfolio including potential first-in-category therapies like Ovaprene® and Sildenafil Cream, 3.6%. The company aims to enhance treatment options in contraception, fertility, and sexual health.
Daré Bioscience (NASDAQ: DARE) will host a conference call on November 10, 2021, at 4:30 p.m. ET to discuss its financial results for Q3 2021 and provide an update on the company. Interested parties can join via phone or through a live webcast available on their website. Daré is focused on women's health, with products in development including Ovaprene, Sildenafil Cream, DARE-BV1, and DARE-HRT1, aimed at contraception, sexual health, and hormone therapy.
Daré Bioscience (NASDAQ: DARE) announced participation in the Xpectives.Health Summit in Boston, MA, from October 12-14, 2021. Sabrina Martucci Johnson, the company’s President and CEO, will join an expert panel to discuss the pharmaceutical industry's commitment to advancing women’s health innovation. The panel, titled Industry and Investors Commitment to Women’s Health, is scheduled for October 14, 2021, from 2:00 to 2:45 pm ET. Daré focuses on developing products that address unmet needs in areas such as contraception, vaginal health, and fertility.
Daré Bioscience announced a Notice of Award from the NICHD granting $309,614 to support the development of DARE-LARC1, a user-controlled long-acting reversible contraceptive (LARC). This funding adds to a previously announced grant of up to $48.95 million. DARE-LARC1 is designed for self-administration, offering flexibility for women to pause or resume contraception without medical intervention. The project aims to meet the unmet needs in women's health while ensuring a comparable contraceptive effectiveness to existing LARCs.
Daré Bioscience has initiated a Phase 1/2 clinical study of DARE-VVA1, an investigational intravaginal tamoxifen product aimed at treating moderate to severe vulvar and vaginal atrophy (VVA) in postmenopausal women, particularly those with hormone receptor-positive breast cancer. The study will assess the safety, pharmacokinetics, and pharmacodynamics of four different doses of DARE-VVA1 over a treatment period of 56 days. This offers a potential non-hormonal alternative to estrogen-based therapies, addressing unmet needs in women's health.
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