Daré Bioscience wins FDA approval for XACIATO antibacterial gel. Nasdaq halted the stock from the time FDA approved Xaciato about 11am that day until 30 minutes after Dare issued their own pr FDA Approves Vaginal Gel for Treatment of Bacterial Vaginosis. DARE-BV1 has Fast Track and QIDP designations from FDA. Let's start up with the current stock price of Dare Bioscience Inc. (DARE), which is $1.99 to be very precise. Ongoing strategic discussions underway to support a robust market introduction of the product in 2022, if approved. The FDA has approved Daré Bioscience Inc.s Xaciato for the treatment of bacterial vaginosis in females 12 years of age and older.Xaciato, formerly known as DARE-BV1, is a viscous gel, which contains the antibiotic Clindamycin at a concentration of 2%, for a one-time vaginal administration with the help of a single-dose user-filled disposable applicator. Afterhours. Most women would prefer a contraceptive method they don't need to remember to take every day and that doesn't . To read the full story on Seeking Alpha, click here. Sildenafil Cream, 3.6% has the Potential to Receive the First FDA Approval for Female Sexual Arousal Disorder. DARE-BV1 (clindamycin phosphate) was approved today by the US Food and Drug Administration (FDA) to treat bacterial vaginosis. san diego, dec. 07, 2021 (globe newswire) -- daré bioscience, inc. (nasdaq: dare), a leader in women's health innovation, today announced that the u.s. food and drug administration (fda) approved. Daré Announces FDA Approval of XACIATO™ (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis. Dare Bioscience gives back most of its strong gains from Tuesday's FDA approval Seeking Alpha - 12/10/2021 2:18:15 PM: Current Report Filing (8-k) Edgar (US Regulatory) - 12/8/2021 4:06:49 PM Current Report Filing (8-k) Edgar (US Regulatory) - 12/7/2021 4:17:45 PM Daré Announces FDA Approval of XACIATO™ (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis GlobeNewswire . Lastly, PagerDuty ( PD ) is up 10.36% after the company beat earnings and revenue estimates while providing upside earnings and revenue guidance for the fourth quarter. Dare Bioscience Inc Registered Shs - - USD 2011 Dare Bioscience Inc Registered Shs . 1.81. With a list price of $6,500 per year, the drug is being pitched at around the same level as the incumbent PCSK9 MAbs; early sales could indicate whether the long-acting therapy can . 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 just received its first FDA approval and is advancing other candidates in its pipeline. On Tuesday, DARE closed the day at $2.12 after surging 10.52% during regular trading hours. 1.81. Ongoing strategic discussions underway to support a robust market introduction of the product in 2022, if approved. The approval marks the first FDA green light for the San Diego company, which said it is in talks on strategic . -0.13 (-6.7%) Upgrade to Real-Time. Dare Bioscience Spoke to Lee Roth who wrote this morning's press release and who does Dare's investor relations. Daré Bioscience, Inc. DARE +4.5% (Get Free Alerts for DARE) rose 45.2% to $3.08 in pre-market trading after the company reported the FDA approval of XACIATO Vaginal Gel as a treatment for bacterial. The increase in stock could be attributed to the approval of . WHIPPANY, N.J. & SAN DIEGO--(BUSINESS WIRE)-- Bayer, a leader in women's health, and DARÉ Bioscience, Inc. (NASDAQ:DARE), a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's health, announced today that the companies have signed a license agreement under which Bayer may commercialize Daré's investigational contraceptive product . SAN DIEGO, Aug. 09 . "The approval marks the first FDA green light for the San Diego company, which said it is in talks on strategic partnering and other activities aimed at supporting . -0.13 (-6.7%) Upgrade to Real-Time. Investors are responding positively to Daré Bioscience announcing that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2% . Six-month priority review granted for DARE-BV1 with PDUFA target action date set for December 7, 2021.NDA supported by positive data from the DARE-BVFREE Phase 3 study, which demonstrated clinical cure rates of 70-81% from a single vaginal dose of DARE-BV1.Ongoing strategic discussions underway to support a robust market introduction of the product in 2022, if approved. SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company's New . Seeking Alpha. Xaciato (clindamycin phosphate vaginal gel . An investigational hormone-free monthly intravaginal contraceptive. SAN DIEGO, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the treatment of bacterial . SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company's New Drug Application (NDA) for DARE-BV1 for the treatment of bacterial vaginosis. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women's reproductive health. Gainers Insignia Systems, Inc. (NASDAQ: ISIG) shares jumped 79% to $18.63. Daré's New Drug Application (NDA) for XACIATO (clindamycin phosphate) vaginal gel (formerly known as DARE-BV1) was approved by the FDA on December 7, 2021. SAN DIEGO, Dec. 07, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE ), a leader in women's health innovation, today announced that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1… View Full Article Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin . Update: Press Release: . The company shares. And it also increased by over 37% after-hours. RTTNews 24d. The FDA has approved Daré Bioscience Inc (NASDAQ: DARE) Xaciato (DARE-BV1) to treat bacterial vaginosis. The Stock rose vividly during the last session to $2.13 after opening rate of $1.93 while the lowest price it went was recorded $1.83 before closing at $1.91.Recently in News on December 7, 2021, Daré Announces FDA Approval of XACIATO™ (clindamycin phosphate) Vaginal Gel as a . Consequently, DARE is trading at $2.92 at the time of the writing. Earnings Whisper. Daré Bioscience's DARE-BV1 is being reviewed by the FDA for treatment of bacterial vaginosis. Johnson said the company aims to develop "differentiated products" that can improve women's "outcomes and convenience". On December 7, 2021, Daré announced that the U.S. Food and Drug Administration (FDA) approved XACIATO [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) (formerly known as DARE-BV1) for the treatment of bacterial vaginosis in females 12 years of age and older. The consensus estimate was a loss of $0.15 per share. OVAPRENE ®. SAN DIEGO, Nov. 12, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today reported financial results for the third quarter ended September 30, 2020 and provided a company update. After a tough 2021, Novartis finally caught a break with the approval of Leqvio, its long-awaited cholesterol-lowering therapy. Current Market Price is $2.92 as of end of AH today (Dec 7). Xaciato FDA Approval History. Daré's lead product candidate, Ovaprene, is a non-hormonal, monthly contraceptive ring that is currently in clinical studies. SAN DIEGO, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced that Sabrina Martucci Johnson, its President and Chief Executive Officer, will deliver a company presentation at the H.C. Wainwright BIOCONNECT 2022 Conference being held virtually January 10 - 13, 2022.. Ms. Johnson's presentation will be available . 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. When it comes to contraception, women value convenience and efficacy. . Daré Bioscience to Participate in H.C. Wainwright BIOCONNECT 2022 Conference GlobeNewswire Inc. - 1/4/2022 8:00:00 AM: Dare Bioscience gives back most of its strong gains from Tuesday's FDA approval Seeking Alpha - 12/10/2021 2:18:15 PM: Current Report Filing (8-k) Edgar (US Regulatory) - 12/8/2021 4:06:49 PM Current Report Filing (8-k) Edgar (US Regulatory) - 12/7/2021 4:17:45 PM New drug application (NDA) submission planned 1H of 2021 SAN DIEGO, Dec. 07, 2020 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's . "The FDA approval of Xaciato marks a major milestone not only for Daré as a company but . Since the FDA approval DARE stock price has declined. Conference Call Today at 4:30 p.m. Eastern Time. 1.81. Daré's New Drug Application (NDA) for XACIATO (clindamycin phosphate) vaginal gel (formerly known as DARE-BV1) was approved by the FDA on December 7, 2021. Meanwhile, Dare Bioscience is up 23.9% after the company announced that the FDA approved XACIATO, a first in its category vaginal gel for the treatment of bacterial vaginosis. This is off the back of FDA approval for Daré's Xaciato as a treatment for bacterial vaginosis. SAN DIEGO, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced that Sabrina Martucci Johnson, its President and Chief Executive Officer, will deliver a company presentation at the H.C. Wainwright BIOCONNECT 2022 Conference being held virtually January 10 - 13, 2022.. Ms. Johnson's presentation will be available . DARE Stock Summary. Last updated by Judith Stewart, BPharm on Dec 8, 2021.. FDA Approved: Yes (First approved December 7, 2021) Brand name: Xaciato Generic name: clindamycin phosphate Dosage form: Vaginal Gel Previous Name: DARE-BV1 Company: Daré Bioscience, Inc. 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