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Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: EVO100
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 07, 2020
Details:
AMPOWER was a single-arm, open-label Phase 3 study designed to evaluate the efficacy and safety of Phexxi™ (lactic acid, citric acid and potassium bitartrate) in preventing pregnancy.
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Lead Product(s): Ferrous Gluconate Anhydrous,Vitamin C
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ovaprene
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Avomeen
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 01, 2020
Details:
Daré and Avomeen are currently collaborating on development-stage programs, including Ovaprene®, an investigational hormone-free, monthly contraceptive, and intend to expand their partnership to include more programs in Daré’s women’s health pipeline.
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Lead Product(s): Relugolix,Estradiol,Norethindrone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: MVT-601
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 17, 2020
Details:
Myovant's NDA for once-daily, oral relugolix combination tablet for the treatment of women with heavy menstrual bleeding associated with uterine fibroids has been accepted for review by the U.S. Food and Drug Administration (FDA).
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Lead Product(s): Relugolix,Estradiol,Norethindrone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: TAK-385
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 06, 2020
Details:
Data from Phase 3 LIBERTY program show improvement in patient-reported outcomes in addition to improvement in hemoglobin levels in anemic women after administration of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg).
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Lead Product(s): Ferrous Gluconate Anhydrous
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ovaprene
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 24, 2020
Details:
Publication of a literature review article by Biology of Reproduction identifies and reviews 10 postcoital test studies of vaginal contraceptives involving 9 test products, including Daré’s Ovaprene, currently under a license agreement with Bayer.
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Lead Product(s): Relugolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
Details:
NDA is supported by positive data from two Phase 3 studies and a long-term extension study, demonstrating sustained reduction in heavy menstrual bleeding while maintaining bone health through one year.
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Lead Product(s): Relugolix,Estradiol,Norethindrone Acetate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 18, 2020
Details:
Co-primary endpoints and six key secondary endpoints met in Phase 3 SPIRIT 2 study in women with endometriosis, with results from the Phase 3 SPIRIT 1 study expected this year.
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Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Undisclosed
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Financing April 27, 2020
Details:
Funding to support the company's launch and commercialization plans for PHEXXI™.
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Lead Product(s): L-Lactic Acid,Citric Acid,Potassium Bitartrate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 24, 2020
Details:
Data demonstrate high efficacy rates of more than 93% when Phexxi is used as directed, also underscore the sexual satisfaction and lubricating factors experienced by women in the AMPOWER trial.
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Lead Product(s): Relugolix
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 10, 2020
Details:
Primary efficacy endpoint met with 87.7% response rate at one year; women experienced, on average, an 89.9% reduction in menstrual blood loss
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