NICHD

The Foundation for the National Institutes of Health Launches First Public-Private Partnership for Early Detection of Preeclampsia

Retrieved on: 
Monday, February 12, 2024

The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia.

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) today announces the launch of a new public-private partnership to develop tools to identify pregnant women at high risk of early-onset preeclampsia.
  • Preeclampsia is a serious pregnancy-related hypertensive disorder that can lead to maternal and neonatal deaths and long-term negative health outcomes.
  • The disorder is becoming more prevalent in the United States, with women of color more likely to be affected and experience poor outcomes.
  • Currently, preeclampsia risk is determined early in pregnancy using a combination of maternal medical history and clinical risk factors.

Daré Bioscience Announces Funding Award Notice from the National Institutes of Health (NIH) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to Support DARE-PTB1 Phase 1 Human Clinical Study

Retrieved on: 
Wednesday, December 13, 2023

SAN DIEGO, Dec. 13, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that it received a Notice of Award of a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), a division of the National Institutes of Health (NIH). The award will support the clinical development of Daré’s novel, investigational intravaginal ring (IVR), DARE-PTB1. DARE-PTB1 is designed to deliver bio-identical progesterone continuously for up to a 14-day period and is being developed as a treatment for the prevention of preterm birth in at-risk women, for which there are currently no FDA-approved treatments.

Key Points: 
  • The award will support the clinical development of Daré’s novel, investigational intravaginal ring (IVR), DARE-PTB1.
  • “Daré is committed to addressing persistent unmet needs in women’s health and preterm birth is a large category that could benefit from new treatment options to protect women and babies.
  • The content of this press release is solely the responsibility of Daré Bioscience, Inc. and does not necessarily represent the official views of the National Institutes of Health.
  • This press release discusses a project that will be supported by the Eunice Kennedy Shriver National Institute of Child Health & Human Development of the National Institutes of Health under Award Number 4R44HD101169-02.

Daré Bioscience Announces Commencement of Phase 3 Study of Ovaprene®, an Investigational Hormone-Free Monthly Intravaginal Contraceptive

Retrieved on: 
Monday, December 4, 2023

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive.

Key Points: 
  • SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced commencement of the Company’s pivotal Phase 3 clinical study of Ovaprene, an investigational hormone-free monthly intravaginal contraceptive.
  • The multi-center, single arm, non-comparative, pivotal Phase 3 clinical study of Ovaprene will evaluate its effectiveness as a contraceptive along with its safety and usability.
  • If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.
  • The agreement gives Daré access to the contraceptive clinical trial expertise of the NICHD clinical trial network while also sharing the costs of the Phase 3 pivotal study with the NICHD.

Daré Bioscience and Premier Research Extend Strategic Partnership to Accelerate the Clinical Development of Daré’s Novel Women’s Health Programs

Retrieved on: 
Monday, November 20, 2023

The agreement was originally established with Health Decisions, Inc., which was acquired by Premier Research in 2021.

Key Points: 
  • The agreement was originally established with Health Decisions, Inc., which was acquired by Premier Research in 2021.
  • “In 2020, Daré and Premier Research conducted a successful Phase 3 clinical study of XACIATO™ (clindamycin phosphate) vaginal gel 2% despite the challenges posed by a global pandemic.
  • “Premier Research is thrilled to renew this partnership and continue our successful work with Daré,” said Michael Arlotto, Ph.D., Chief Operating Officer of Premier Research.
  • “This partnership underscores our joint commitment to advancing women’s health by supporting efforts to include women in clinical research and bring novel products to market.

Daré Bioscience Reports Third Quarter 2023 Financial Results and Provides Company Update

Retrieved on: 
Thursday, November 9, 2023

SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2023 and provided a company update.

Key Points: 
  • ET
    SAN DIEGO, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended September 30, 2023 and provided a company update.
  • XACIATO™ provides a new therapeutic option for the millions of women suffering from bacterial vaginosis in the U.S.
  • Financial Highlights for the Quarter ended September 30, 2023
    Cash and cash equivalents: $13.8 million at September 30, 2023.
  • Daré will host a conference call and live webcast today, November 9, 2023, at 4:30 p.m. Eastern Time to review financial results for the quarter ended September 30, 2023 and to provide a company update.

Daré Bioscience Announces Grant Funding Installment to Support Further Development of Novel Contraceptive Technology DARE-LARC1

Retrieved on: 
Thursday, September 21, 2023

Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1.

Key Points: 
  • Under the terms of the grant agreement, Daré may receive a total of up to approximately $49 million to support nonclinical development of DARE-LARC1.
  • Daré received an initial $11.5 million payment in 2021 and aggregate payments of approximately $12.4 million in 2022 under the grant agreement.
  • “The DARE-LARC1 product candidate is one of a number of novel contraceptive technologies being developed by Daré,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • Bayer, in its sole discretion, has the right to make the license effective by paying $20.0 million to Daré.

The FNIH Awards 2023 Charles A. Sanders, M.D., Partnership Award to NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family

Retrieved on: 
Monday, September 18, 2023

The Foundation for the National Institutes of Health (FNIH) has named the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family as recipients of the 2023 Charles A. Sanders, M.D., Partnership Award .

Key Points: 
  • The Foundation for the National Institutes of Health (FNIH) has named the National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, GSK, and the O’Neill Family as recipients of the 2023 Charles A. Sanders, M.D., Partnership Award .
  • The Partnership Award recognizes persons or organizations that have made significant contributions to the FNIH’s work in support of the mission of the National Institutes of Health (NIH).
  • The Azithromycin Prevention in Labor Use Study (A-PLUS) assessed low-cost, sustainable interventions to improve maternal and child health.
  • The Charles A. Sanders, M.D., Partnership Award is named for the former Chairman of the FNIH Board of Directors.

Daré Bioscience Reports Second Quarter 2023 Financial Results and Provides a Company Update

Retrieved on: 
Thursday, August 10, 2023

SAN DIEGO, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended June 30, 2023, and provided a company update.

Key Points: 
  • 2, 3
    A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare.
  • Financial Highlights for the Quarter ended June 30, 2023
    Cash and cash equivalents: $13.3 million at June 30, 2023.
  • Daré will host a conference call and live webcast today at 4:30 p.m. Eastern Time to review financial results for the quarter ended June 30, 2023 and to provide a company update.
  • The webcast and presentation slides will be archived under “Presentations, Events & Webcasts" in the Investors section of the Company's website at http://ir.darebioscience.com and available for replay until August 24, 2023.

Daré Bioscience Announces Grant Award Supporting Development of Potential New Therapeutic Intervention for the Prevention of Idiopathic Preterm Birth

Retrieved on: 
Monday, July 31, 2023

SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it was awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $385,000 to support activities related to the conduct and completion of proof-of-concept target validation studies in support of a potential new approach for the prevention and treatment of idiopathic preterm birth. Daré will collaborate with its sub awardee, the Lockwood Laboratory at the University of South Florida (USF) Morsani College of Medicine, on the grant-funded activities.

Key Points: 
  • SAN DIEGO, July 31, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it was awarded a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) in the amount of approximately $385,000 to support activities related to the conduct and completion of proof-of-concept target validation studies in support of a potential new approach for the prevention and treatment of idiopathic preterm birth.
  • Daré will collaborate with its sub awardee, the Lockwood Laboratory at the University of South Florida (USF) Morsani College of Medicine, on the grant-funded activities.
  • Preterm birth is defined as a live birth before 37 completed weeks of gestation.1,2 Premature babies often have serious health problems.
  • March of Dimes PeriStats™, Preterm Birth, accessed 28 July 2023. https://www.marchofdimes.org/peristats/data?reg=99&slev=4&top=3

Daré Bioscience Reports First Quarter 2023 Financial Results and Provides a Company Update

Retrieved on: 
Thursday, May 11, 2023

SAN DIEGO, May 11, 2023 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the quarter ended March 31, 2023 and provided a company update.

Key Points: 
  • A proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical administration to treat female sexual arousal disorder.
  • Financial Highlights for the Quarter ended March 31, 2023
    Cash and cash equivalents: $19.8 million at March 31, 2023.
  • Daré will host a conference call and live webcast today at 4:30 p.m. Eastern Time to review financial results for the quarter ended March 31, 2023 and to provide a company update.
  • The webcast will be archived under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com and available for replay until May 25, 2023.