Valuation metrics show that Dare Bioscience, Inc. may be overvalued. Its Value Score of F indicates it would be a bad pick for value investors. The financial health and growth prospects of DARE, demonstrate its potential to underperform the market.
Similarly What rating is dare Bioscience? The consensus rating score for Daré Bioscience is 3.00 while the average consensus rating score for medical companies is 2.73.
When was DARE Stock FDA approved? Development Timeline for Xaciato
| Date | Article |
|---|---|
| Dec 7, 2021 | Approval FDA Approves Xaciato (clindamycin phosphate) Vaginal Gel as a Treatment for Bacterial Vaginosis |
| Aug 9, 2021 | Daré Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis |
• 8 déc. 2021
Additionally, What is the stock of DARE Pharma?
(DARE) Stock Price, News, Quote & History – Yahoo Finance.
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Performance Outlook.
| Previous Close | 1.4900 |
|---|---|
| 52 Week Range | 1.2000 – 2.5100 |
| Volume | 6,361,573 |
| Avg. Volume | 2,143,816 |
What is DARE Bioscience FDA approval?
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 .
Is DARE Stock FDA approved? 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.
Is DARE Stock News approved by the FDA? Dare Bioscience (NASDAQ:DARE) recently rallied 30.0% on the news of FDA approval of XACIATO for bacterial vaginosis in women on Dec. 7, 2021. Since the FDA approval DARE stock price has declined for no fundamental reason other than the stock market weakness.
Can I dare Bioscience bacterial vaginosis? DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing clindamycin phosphate 2% designed as a one-time vaginally-administered treatment for bacterial vaginosis.
Is DARE Stock FDA approved?
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.
What does dare Bioscience do? Dare Bioscience, Inc. operates as a healthcare company. The Company offers women’s reproductive health devices, therapeutics, and diagnostics. Dare Bioscience provides contraception, vaginal health, pain, and fertility products.
Did DARE get FDA approval?
DARE-BV1, a gel that treats bacterial vaginosis, was granted FDA approval on its Prescription Drug User Fee Act (PDUFA) date today. DARE-BV1 (clindamycin phosphate) was approved today by the US Food and Drug Administration (FDA) to treat bacterial vaginosis.
What is Pdufa action date? In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application.
What is DARE Bioscience press release?
Press Releases
- Daré Bioscience to Host Full-year 2021 Financial Results and Company Update Conference Call and Webcast on March 31, 2022. 03-24-2022.
- Daré Bioscience to Present at the Maxim 2022 Virtual Growth Conference. 03-22-2022.
- Daré Bioscience to Participate in Upcoming Conferences. 03-02-2022.
What is Xaciato?
XACIATO is a lincosamide antibacterial indicated for the. treatment of bacterial vaginosis in female patients 12 years of. age and older. (
Who is the CEO of DARE Bioscience? Sabrina Martucci Johnson. Ms. Johnson founded Daré Bioscience Operations in 2015 and has served as President, CEO and a member of the Board of Directors since its inception and following its business combination with Cerulean Pharma in July 2017, when the Company was renamed Daré Bioscience.
What is the latest news in Dare Bioscience? Press Releases
- Daré Bioscience Reports Full-Year 2021 Financial Results and Provides a Company Update. …
- Organon Enters into Global License Agreement to Commercialize Daré Bioscience’s XACIATO™ (clindamycin phosphate vaginal gel, 2%), FDA-Approved Treatment for Females 12 and Older with Bacterial Vaginosis (BV)
What you mean by Dare?
1a : to challenge to perform an action especially as a proof of courage dared him to jump. b : to confront boldly : defy dared the anger of his family. 2 : to have the courage to contend against, venture, or try the actress dared a new interpretation of the classic role.
What happens on Pdufa date? In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application.
Can PDUFA date be extended?
While PDUFA dates are set after a regulatory filing is accepted, the dates aren’t set in stone. The FDA does occasionally extend the review period, most commonly when additional data is required from the drugmaker or the company itself submits additional data that requires more time to review.
What percentage of PDUFA are approved? In the first few years of the Prescription Drug User Fee Act (PDUFA) program, the first cycle approval rate for new drugs was as low as 23 percent. Now it is about 80 percent on average .
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| Brand (Generic Name) | Indication |
|---|---|
| Banzel (Rufinamide) | Seizures |
How long does BLA approval take?
Review Timeline
As per the Prescription Drug User Fee Act (PDUFA), the FDA agreed to review the majority of BLAs within 10 months of 60 day filing and for the priority submissions it has been cut down to 6 months of 60 day filing date.