Associated tags: Health, Birth, Fertility, SAN, Pharmaceutical industry, Woman, FDA, Cream, Birth control, Female
Locations: BOSTON, FLORIDA, NEW ZEALAND, EASTERN, SAN DIEGO, CA, US, UNITED STATES, MASSACHUSETTS
To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free).
Key Points:
- To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free).
- The live webcast can be accessed under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com .
- Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software.
- 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 28, 2024.
FDA,
LARC,
Woman,
Levonorgestrel,
Software,
Diabetes,
Communication,
Fertility,
Birth,
Osteoporosis,
Obesity,
Human,
Patient,
Electronics,
DSM-IV codes,
Condition,
Investigational New Drug,
Injection,
Pharmaceutical industry SAN DIEGO, April 23, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it will receive a payment of $1 million as the latest installment under a grant agreement to advance the development of Daré’s investigational contraceptive DARE-LARC1 through nonclinical proof of principle studies and other IND-enabling work to allow for the submission of an Investigational New Drug (IND) Application with the FDA, approval of which will be required to commence testing in humans. 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. To date, Daré has received payments totaling approximately $28.3 million. Additional payments are conditioned on the program meeting specified development and reporting milestones.
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.
- Additional payments are conditioned on the program meeting specified development and reporting milestones.
- “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.
- To support development opportunities outside of the reproductive health category, including diabetes, obesity, and other conditions requiring precise and prolonged treatment, Daré is exploring strategic discussions with potential industry partners.
FDA,
Birth control,
Bangladesh Technical Education Board,
NIH,
Woman,
Human services,
NICHD,
Trial of the century,
Research,
Development,
CRADA,
PCT,
Human development,
SAN SAN DIEGO, April 11, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced the publication of data from the postcoital test clinical study of Ovaprene in two original research articles in the journal Contraception.
Key Points:
- “Successful postcoital testing of Ovaprene: An investigational non- hormonal monthly vaginal contraceptive.” Contraception.
- “Safety Testing of Ovaprene: an Investigational Non-Hormonal Monthly Vaginal Contraceptive.” Contraception.
- Advance online publication, 110440. https://doi.org/10.1016/j.contraception.2024.110440
“We are very pleased to have the postcoital test study results for our investigational, hormone-free intravaginal contraceptive Ovaprene published in a leading reproductive health journal,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
- If successful, Daré expects the pivotal study to support marketing approvals of Ovaprene in the U.S. and other countries.
Cream,
Dysmenorrhea,
Patient,
History,
Bacteria,
G&A,
Vaginal discharge,
IND,
Bayer,
Human development,
Investment,
Diclofenac,
NSAID,
Menstruation,
Research,
Hormone,
Bacterial vaginosis,
P-value,
Webcast,
SAN,
NIH,
Trial of the century,
Pleasure,
Woman,
Breast cancer,
Safety,
Pharmacokinetics,
Food,
Development,
Menopause,
Nonsteroidal anti-inflammatory drug,
HR,
ARPA,
VVA,
Tamoxifen,
FDA,
Attention,
CRADA,
Female,
Dyspareunia,
Ecosystem,
NICHD,
Bangladesh Technical Education Board SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.
Key Points:
- In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
- In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
- Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
Cash and cash equivalents: $10.5 million at December 31, 2023.
- Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.
To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (international).
Key Points:
- To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (international).
- The live webcast can be accessed under “Presentations, Events & Webcasts" in the Investors section of the company's website at http://ir.darebioscience.com .
- Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software.
- 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 April 11, 2024.
Retrieved on:
Thursday, February 22, 2024
Cream,
FSAD,
Orgasm,
Woman,
Embarrassment,
FDA,
Food,
Female,
Erectile dysfunction,
Guilt,
Pharmaceutical industry SAN DIEGO, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that additional data from the exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% (Sildenafil Cream) in women with female sexual arousal disorder (FSAD) will be presented at the upcoming International Society for the Study of Women’s Sexual Health (ISSWSH) Annual Meeting. These data include efficacy results across multiple endpoints in the proposed Phase 3 study population.
Key Points:
- “The results highlight specific endpoints with the strongest responses including arousal sensation, desire, orgasm, as well as stress, guilt, and embarrassment about the sexual dysfunction.
- Notably, Sildenafil Cream enhanced solo, unpartnered sexual experiences, which represented approximately 1 in 5 sexual events in the Phase 2b RESPOND study.
- “We are excited to share additional data from this groundbreaking study in one of the leading forums for scientific research on female sexual dysfunction,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
- Daré Bioscience previously announced a positive end-of-Phase 2 meeting with the FDA supporting advancement of Sildenafil Cream for the treatment of FSAD.
Retrieved on:
Wednesday, January 31, 2024
Cream,
SAN,
Orgasm,
Embarrassment,
Trial of the century,
Arousal,
Feedback,
FSAD,
Patient,
FDA,
Guilt,
Food,
Woman,
Female,
NDA,
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Pharmaceutical industry The Company also provided an update on focus areas for 2024.
Key Points:
- The Company also provided an update on focus areas for 2024.
- The Company and the FDA aligned on key elements of the Phase 3 program to support a New Drug Application (NDA) filing, including confirming that:
FSAD is acceptable as an indication.
- 12-weeks of blinded treatment to assess efficacy may be acceptable, provided that the trials are adequately powered for efficacy assessment.
- In addition to the significant progress with Sildenafil Cream, Daré continues to build on numerous milestones and achievements from 2023.
Cream,
IP,
Employment,
LLP,
Digital Equipment Corporation,
SAN,
San Diego State University,
Biotechnology,
Female,
Business administration,
Accounting,
Retirement,
Management We also appreciate Dr. Blanchard’s and Dr. Ononye-Onyia’s seasoned counsel and insights as Board members and their future support as advisors,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
Key Points:
- We also appreciate Dr. Blanchard’s and Dr. Ononye-Onyia’s seasoned counsel and insights as Board members and their future support as advisors,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
- Following a periodic assessment by our Board of Directors of its size and composition, our Board determined that a reduction in the number of directors would help rightsize the Board to our current operations and further align the size of our Board with boards of companies of similar size.
- The size of our Board will be reduced from eight to six members effective as of our 2024 annual meeting of stockholders.
- In addition, in connection with the periodic assessment, our Board also determined to reduce the annual cash compensation payable to non-employee directors to the 25th percentile of our peer group of companies.
Retrieved on:
Wednesday, January 17, 2024
SAN DIEGO, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has received a grant from the Bill & Melinda Gates Foundation (the foundation) of $750,000 to fund activities related to bacteria-based live biotherapeutic product development.
Key Points:
- SAN DIEGO, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced it has received a grant from the Bill & Melinda Gates Foundation (the foundation) of $750,000 to fund activities related to bacteria-based live biotherapeutic product development.
- Daré previously received a grant of approximately $585,000 from the foundation for development of a hydrogel formulation for delivery of live biotherapeutics to support vaginal health in November 2022.
- The additional grant is intended to cover the costs of Daré personnel to gather and analyze data on the global bacterial biologic supply chain to help the foundation identify potential Contract Manufacturing Organization (CMO) partners for manufacturing clinical and commercial supplies of bacteria-based biotherapeutic products.
- This work will benefit women and newborns as the primary patient populations for interventions where bacteria consortia products are an important modality in the therapeutic arsenal,” said David Friend, PhD, Chief Scientific Officer of Daré Bioscience.
Retrieved on:
Thursday, January 4, 2024
Levonorgestrel,
LARC,
Woman,
IND,
Software,
FDA,
Injection,
Electronics,
Diabetes,
SAN,
Fertility,
DSM-IV codes,
Osteoporosis,
Obesity,
Patient,
Birth,
Communication This milestone reflects the drug delivery platform’s potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections.
Key Points:
- This milestone reflects the drug delivery platform’s potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections.
- Daré is currently developing the platform technology internally with funding from a foundation grant in DARE-LARC1, a potential new class of long-acting, reversible contraceptive (LARC).
- Key features of the implant technology include:
Precision dosing: Unique design allows for precise dose timing and amount using individually addressable drug micro-reservoirs.
- Smartphone integration: Platform can be paired with custom mobile apps designed for each application to create a personalized experience for the user.
