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Lead Product(s): APL-1702
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Cevira
Highest Development Status: Phase III Product Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2020
Details:
APL-1702 (Cevira ® ) is a photodynamic drug device combination product. Based on the principle of photodynamics, it combines a photosensitizer with a specific wavelength of light activation to produce a therapeutic effect.
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Lead Product(s): Linzagolix,Hormonal add-back therapy
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Yselty
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 22, 2020
Details:
Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a best-in-class profile. Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.
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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 October 21, 2020
Details:
Company to present data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and in women with uterine fibroids at the ASRM 2020 Virtual Congress.
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Lead Product(s): Nolasiban
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: OBE001
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 20, 2020
Details:
Results support the further evaluation of higher doses and/or alternate regimens of nolasiban. ObsEva is partnering with YuYuan BioScience Technology, a Chinese company, for the development of nolasiban.
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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 20, 2020
Details:
EVOGUARD is a double-blind, placebo-controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of EVO100 for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhea infection in women.
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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: Adjuvant Capital
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Financing October 15, 2020
Details:
Proceeds from the sale of the notes will be used to support EVOGUARD, Evofem's planned Phase 3 clinical trial of EVO100 for the prevention of urogenital chlamydia and gonorrhea in women, and to expand global market access for Phexxi™ vaginal contraceptive gel.
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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,Ascorbic Acid
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): Photodynamic drug
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Cevira
Highest Development Status: Phase III Product Type: Undisclosed
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 08, 2020
Details:
Asieris has received Clinical Trial Approval from China NMPA for the global, multi-centered Phase III clinical trial of its photodynamic drug-device combination product Cevira®, which is being developed for the non-surgical treatment of high-grade cervical dysplasia.
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