CSBio CSBio

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Health)","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Outside the US Bayer Extends Development Program for Investigational Product Elinzanetant With Phase III Study in Breast Cancer Patients With Vasomotor Symptoms Caused by Endocrine Therapy","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Astellas Pharma"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Mithra Announces Completion of Recruitment in Pediatric Study of Estelle in Adolescent Patients","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Mithra Pharmaceuticals"},{"orgOrder":0,"company":"ObsEva","sponsor":"Yuyuan","pharmaFlowCategory":"D","amount":"$132.0 million","upfrontCash":"Undisclosed","newsHeadline":"ObsEva Recovers Full Worldwide Rights on Nolasiban","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"SWITZERLAND","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"ObsEva"},{"orgOrder":0,"company":"Mithra Pharmaceuticals","sponsor":"SEARCHLIGHT PHARMA INC","pharmaFlowCategory":"D","amount":"$18.7 million","upfrontCash":"Undisclosed","newsHeadline":"Mithra and Searchlight Pharma Announce Donesta\u00ae Licensing Agreement for Canada","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"BELGIUM","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Mithra Pharmaceuticals"},{"orgOrder":0,"company":"VistaGen Therapeutics","sponsor":"Pherin Pharmaceuticals","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Vistagen Announces Positive Results from Exploratory Phase 2A Study of PH80 for Acute Management of the Symptoms of Premenstrual Dysphoric Disorder","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"VistaGen Therapeutics"},{"orgOrder":0,"company":"Gedeon Richter","sponsor":"Sumitomo","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Gedeon Richter and Sumitomo Pharma Receive Positive CHMP Opinion for RYEQO\u00ae for Treatment of Endometriosis","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"HUNGARY","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Gedeon Richter"},{"orgOrder":0,"company":"Asieris Pharmaceuticals","sponsor":"Photocure","pharmaFlowCategory":"DU","amount":"Not 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molecule","graph2":"Mithra Pharmaceuticals"},{"orgOrder":0,"company":"Bayer AG","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Bayer\u2019s Elinzanetant Meets All Primary and Key Secondary Endpoints in Pivotal OASIS 1 and 2 Phase III Studies","therapeuticArea":"Obstetrics\/Gynecology (Women\u2019s Health)","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2024","url1":"","url2":"","graph1":"Small molecule","graph2":"Bayer AG"}]

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            Details:

            BAY-3427080 (elinzanetant) is a first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.

            Lead Product(s): Elinzanetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: BAY-3427080

            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 January 08, 2024

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            Under the terms of the agreement, Searchlight will have sales and marketing rights for DONESTA® in Canada. DONESTA (estetrol) phase 3 clinical program, which demonstrated a meaningful reduction in the frequency and severity of vasomotor symptoms compared to placebo.

            Lead Product(s): Estetrol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC

            Deal Size: $17.9 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement October 26, 2023

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            Cevira (APL-1702) is a photodynamic drug-device combination product in development for the non-surgical treatment of high-grade squamous intraepithelial lesions (HSIL), licensed to Asieris by Photocure.

            Lead Product(s): APL-1702

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Cevira

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Photocure

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 20, 2023

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            Ryeqo (relugolix, estradiol, and norethisterone acetate) receives positive opinion by CHMP recommending approval in for the adjuvant treatment of endometriosis in women with a history of previous medical or surgical treatment for their endometriosis.

            Lead Product(s): Relugolix,Estradiol,Norethisterone Acetate

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Ryeqo

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Sumitomo

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 15, 2023

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            PH80 is a first-in-class, rapid-onset product candidate, designed to be used in a manner analogous to a rescue inhaler for acute management of the symptoms of premenstrual dysphoric disorder.

            Lead Product(s): PH80

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: PH80

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Pherin Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 12, 2023

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            Under the agreement, Searchlight will have the Canadian rights to Donesta, a next generation orally administered Estetrol (E4)-based hormone therapy product, for the treatment of the symptoms of menopause.

            Lead Product(s): Estetrol

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Donesta

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: SEARCHLIGHT PHARMA INC

            Deal Size: $18.7 million Upfront Cash: Undisclosed

            Deal Type: Licensing Agreement July 31, 2023

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            Under the termination of agreement with Yuyuan, ObsEva recovered full worldwide rights on OBE001 (nolasiban), a novel, oral oxytocin receptor antagonist being developed to improve pregnancy and live birth rates in women undergoing embryo transfer after in vitro fertilization.

            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: Yuyuan

            Deal Size: $132.0 million Upfront Cash: Undisclosed

            Deal Type: Termination July 13, 2023

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            Estelle® is a novel patent protected combined oral contraceptive pill containing 3 mg drospirenone (DRSP) and 15 mg estetrol (E4). E4 is a naturally produced estrogen during pregnancy, which can now be made from a plant source.

            Lead Product(s): Estetrol,Drospirenone

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: Estelle

            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 10, 2023

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            Details:

            ESN364 (fezolinetant) works by blocking NKB binding on the kisspeptin/neurokinin B/dynorphin neuron to modulate neuronal activity in the hypothalamus to reduce the frequency and severity of moderate to severe VMS due to menopause.

            Lead Product(s): Fezolinetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: ESN364

            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 20, 2023

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            Details:

            BAY3427080 (elinzanetant) is an oral, once-daily, non-hormonal, selective neurokinin-1,3 (NK-1,3) receptor antagonist that is being studied for the reduction of vasomotor symptoms (VMS).

            Lead Product(s): Elinzanetant

            Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Product Name: BAY3427080

            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 02, 2023

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