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ObsEva SA: ObsEva Announces First Quarter 2021 Financial Results and Business Update

-Yselty for uterine fibroids: US New Drug Application submission planned in Q3:21; European marketing approval recommendation anticipated in Q4:21- -Yselty for endometriosis: Readout from Phase ....

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ObsEva Announces Year End 2020 Financial Results and Business Update

ObsEva Announces Year End 2020 Financial Results and Business Update
March 05, 2021 01:00 ET
| Source:
ObsEva SA
ObsEva SA
Plan-Les-Ouates Geneva, SWITZERLAND
-Yselty® for uterine fibroids: US New Drug Application filing planned in Q2:21; European marketing approval anticipated in Q4:21-
-Yselty® for endometriosis: Readout from Phase 3 EDELWEISS 3 study
expected in Q4:21-
-Ebopiprant: Phase 2b dose ranging study planned to initiate in Q4:21 based on positive Phase 2a proof of concept-
-Actively pursuing new indications and partnerships to maximize value of pipeline candidates-

GENEVA, Switzerland and BOSTON, MA – March 5, 2021 – ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today reported financial results for the year end ....

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ObsEva SA: ObsEva Provides Business Outlook for 2021

ObsEva SA: ObsEva Provides Business Outlook for 2021
GENEVA, Switzerland and BOSTON, MA (February 10, 2021) - ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women s reproductive health, today provided a corporate update, including its roadmap for advancing its clinical programs in 2021.
We made significant progress across all aspects of the company in 2020, most significantly preparing Yselty for uterine fibroids for regulatory approval with a filed and validated European marketing authorization application and an upcoming planned new drug application in the US, said Brian O Callaghan, CEO of ObsEva. Meanwhile our other pipeline programs have continued to advance through development as evidenced by the recent exciting topline results from the PROLONG Phase 2a proof-of concept study of ebopiprant which, to our knowledge, is the only candidate drug in active development that has the potential to d ....

United States , Shauna Dillon , David Renas , Brian Ocallaghan , Joyce Allaire , Ayman Al Hendy , George Saade , Fetal Medicine Division , Clinical Development Details , Swiss Exchange , Exchange Commission , Merck Kga , Merck Kgaa , University Of Texas Medical Branch In Galveston , European Medicine Agency , Briano Callaghan , Distinguished Professor , Chicago Division , African American , Hispanic African American , Preterm Labor , Maternal Fetal Medicine Division , Texas Medical Branch , Vitro Fertilization , Financial Guidance , Nasdaq Global Select Market ,

ObsEva Provides Business Outlook for 2021

for Uterine Fibroids
ObsEva is developing Yselty®, an oral GnRH receptor antagonist with the potential to treat more women thanks to its potential best-in-class efficacy, a favorable tolerability profile and unique, flexible dosing options for the treatment of uterine fibroids. Following the European Medicine Agency’s (EMA) recent validation of the marketing authorization application (MAA), a major milestone toward making Yselty® available in the E.U., the Company will continue to work closely with the EMA to achieve marketing approval, projected in Q4:2021.
The second key objective for 2021 will be to submit a U.S. New Drug Application (NDA), projected in Q2:2021, that will include the Week 76 post-treatment follow-up results from the Phase 3 PRIMROSE 1 (US only; n=574) and PRIMROSE 2 (Europe and US; n=535) clinical studies. In both studies, patients with heavy menstrual bleeding (HMB) associated with uterine fibroids were administered Yselty doses of 100 mg or 200 m ....

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Investegate |ObsEva SA Announcements | ObsEva SA: ObsEva Provides Business Outlook for 2021

ObsEva Provides Business Outlook for 2021

GENEVA, Switzerland and BOSTON, MA (February 10, 2021) – ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve women’s reproductive health, today provided a corporate update, including its roadmap for advancing its clinical programs in 2021.
“We made significant progress across all aspects of the company in 2020, most significantly preparing Yselty® for uterine fibroids for regulatory approval with a filed and validated European marketing authorization application and an upcoming planned new drug application in the US,” said Brian O’Callaghan, CEO of ObsEva. “Meanwhile our other pipeline programs have continued to advance through development as evidenced by the recent exciting topline results from the PROLONG Phase 2a proof-of concept study of ebopiprant which, to our knowledge, is the only candidate drug in active development that has the pote ....

United States , Shauna Dillon , David Renas , Brian Ocallaghan , Joyce Allaire , Ayman Al Hendy , George Saade , Fetal Medicine Division , Clinical Development Details , Swiss Exchange , Exchange Commission , Merck Kga , Merck Kgaa , University Of Texas Medical Branch In Galveston , European Medicine Agency , Obseva Provides Business Outlook , Briano Callaghan , Drug Application , Distinguished Professor , Chicago Division , African American , Hispanic African American , Preterm Labor , Maternal Fetal Medicine Division , Texas Medical Branch , Vitro Fertilization ,