Welcome to our dedicated page for Dare Bioscience news (Ticker: DARE), a resource for investors and traders seeking the latest updates and insights on Dare Bioscience stock.
Daré Bioscience, Inc. develops and commercializes women’s health therapies across contraception, fertility, vaginal health, and sexual health. Its updates center on XACIATO, DARE to PLAY™ Sildenafil Cream, and investigational programs such as DARE-HPV and DARE-PTB1, an intravaginal ring program for prevention of preterm birth.
Recurring news themes include financial results, company updates, product availability through prescription and 503B channels, FDA and IND-related development milestones, clinical-program disclosures, and non-dilutive funding from government sources. Coverage also reflects Daré’s public reporting on product candidates, trials, financing, and business development.
Daré Bioscience (NASDAQ: DARE), a women's health innovation company, has announced it will host a conference call and webcast on November 14, 2024, at 4:30 p.m. Eastern Time to discuss its third quarter 2024 financial results and provide a company update. The financial results will be released after market close on the same day. Participants can join via phone at (646) 307-1963 (U.S.) or (800) 715-9871 (international) using conference ID 6400145. A webcast will be available on the company's investor relations website and archived until November 28, 2024.
Daré Bioscience has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program for the development of DARE-HPV, a potential first-in-category treatment for HPV-related cervical disease. The funding will be distributed over two years through the launchpad track for later-stage health solutions. DARE-HPV aims to provide an alternative to current surgical treatments, which can increase risks of preterm birth and sexual dysfunction. The treatment could potentially address both late-stage cervical lesions and earlier stage HPV-related cervical infections, potentially transforming clinical HPV management with an at-home strategy.
Daré Bioscience has entered into a $15 million common stock purchase agreement with Lincoln Park Capital Fund, (LPC). This 24-month agreement allows Daré to sell up to $15 million of its stock to LPC at its discretion, subject to SEC approval and other conditions. Daré will control the timing and amount of sales, with LPC purchasing at prevailing market prices. The agreement provides Daré with access to capital to fund portfolio advancement, particularly the Phase 3 program for Sildenafil Cream, 3.6%, a potential first-in-category treatment for female sexual arousal disorder. The agreement includes no warrants, short selling restrictions, or limitations on use of proceeds. Daré can terminate the agreement at any time without penalty.
Daré Bioscience (NASDAQ: DARE) announced the publication of safety data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, involving 1,357 sexual experiences, showed that the topical cream was safe and well-tolerated by women with female sexual arousal disorder (FSAD) and their partners. Notably, the cream did not produce common side effects associated with oral sildenafil, such as headache and flushing. This is likely due to the hundred-fold lower systemic exposure compared to oral dosing. The study was designed to identify the most responsive patient population and appropriate patient-reported outcome measures for future Phase 3 trials. Daré is currently in discussions with the FDA regarding the development program for Sildenafil Cream as an FSAD treatment.
Daré Bioscience (NASDAQ: DARE) announced the publication of additional data from its Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% in The Journal of Sexual Medicine. The study, focusing on female sexual arousal disorder (FSAD), revealed that 1-month and 24-hour recall patient reported outcome (PRO) instruments yielded similar responses. This finding supports the use of either method for assessing treatment efficacy in future clinical studies, with longer recall intervals being less burdensome for participants and potentially improving data collection compliance.
The company previously announced a positive end-of-Phase 2 meeting with the FDA, supporting the advancement of Sildenafil Cream for FSAD treatment. Daré continues to interact with the FDA on the development program. Efficacy data from the Phase 2b RESPOND study were also published in Obstetrics & Gynecology.
Daré Bioscience (NASDAQ: DARE) reported Q2 2024 financial results and provided a company update. Key highlights include:
1. Ongoing enrollment in the Ovaprene Phase 3 contraceptive efficacy study across the U.S.
2. Progress on Sildenafil Cream, 3.6% for female sexual arousal disorder, awaiting FDA feedback on Phase 3 study design.
3. Cash and cash equivalents of $16.4 million as of June 30, 2024.
4. Q2 2024 R&D expenses decreased 19% to $4.9 million, while G&A expenses decreased to $2.4 million.
5. Received $22 million in April 2024 from a non-dilutive royalty monetization transaction.
The company continues to focus on advancing its late-stage candidates, all representing first-in-category opportunities in women's health.
Daré Bioscience (NASDAQ: DARE), a leader in women's health innovation, has announced its upcoming second quarter 2024 financial results conference call and webcast. The event is scheduled for August 12, 2024, at 4:30 p.m. Eastern Time. The company will release its financial results for the quarter ended June 30, 2024, after market close on the same day. Investors can access the call via phone or live webcast, with dial-in numbers provided for both U.S. and international participants. The conference ID is 6756565. The webcast will be available under the Investors section of Daré's website and will remain accessible for replay until August 26, 2024.
Daré Bioscience (NASDAQ: DARE) has regained compliance with Nasdaq's minimum bid price rule, as announced on July 19, 2024. The company's stock closed at $1.00 or higher for 10 consecutive trading sessions, meeting the Nasdaq Listing Rule 5550(a)(2) requirement. CEO Sabrina Martucci Johnson expressed enthusiasm about this development, stating it strengthens the company's market position and enhances its ability to advance its vision.
Johnson also provided updates on key programs in Daré's portfolio:
- Ongoing enrollment in the pivotal Phase 3 study of Ovaprene®, a potential first-in-category hormone-free monthly intravaginal contraceptive
- Continued activities supporting progression toward a Phase 3 trial of Sildenafil Cream, 3.6% for female sexual arousal disorder, an area with no current FDA-approved treatments
The company remains focused on accelerating the development of innovative treatments for women's health, with an emphasis on first-in-category opportunities.
Daré Bioscience (NASDAQ: DARE) will implement a 1-for-12 reverse stock split of its common shares effective July 1, 2024. This action aims to elevate the stock's bid price to meet Nasdaq's $1.00 minimum bid price requirement. Authorized by shareholders on June 5, 2024, the reverse split will reduce the total number of outstanding shares from about 101.1 million to 8.4 million, while also adjusting the exercise prices and number of shares underlying stock options and warrants. No fractional shares will be issued; instead, fractional interests will be rounded up. The stock will continue trading under the symbol 'DARE' with a new CUSIP number 23666P200.
Daré Bioscience (NASDAQ: DARE) published the efficacy results of their Phase 2b study on topical Sildenafil Cream, 3.6% for treating Female Sexual Arousal Disorder (FSAD) in the journal Obstetrics & Gynecology. This double-blind, placebo-controlled study showed significant improvements in sexual arousal sensation, reduced sexual distress, and increased desire and orgasm, particularly in a subset of women with FSAD, with or without decreased desire. Currently, no FDA-approved therapies exist for FSAD. Daré had a positive end-of-Phase 2 meeting with the FDA and awaits feedback on proposed endpoints for Phase 3 trials, which is expected this quarter.