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ObsEva SA (NASDAQ: OBSV) announced on July 15, 2020, that it won the Clinical Science Award for Oral Presentation at the ESHRE Virtual 36th Annual Meeting, held from July 5-8, 2020. The award recognized Dr. Hugh Taylor for his presentation on the efficacy and safety of linzagolix for treating heavy menstrual bleeding due to uterine fibroids, showcasing results from a Phase 3 trial. ObsEva is focused on developing therapies for women’s reproductive health, and linzagolix is in late-stage development for treating related conditions.
ObsEva SA (NASDAQ: OBSV) announced positive results from the PRIMROSE 1 and 2 studies for Yselty® (linzagolix), demonstrating significant reduction in menstrual blood loss in women with uterine fibroids. At 24 weeks, 75.5% of patients on 200 mg with Add Back Therapy achieved responder status. At 52 weeks, responder rates remained high at 91.6%. The studies support linzagolix as a viable treatment option, especially for those contraindicated for ABT. Regulatory submissions for EU and US are expected in 4Q 2020 and 1H 2021, respectively.
ObsEva SA (NASDAQ: OBSV), a clinical-stage biopharmaceutical company focused on women's reproductive health, announced its participation in the ESHRE Virtual 36th Annual Meeting from July 5-8, 2020. Dr. Hugh Taylor will present on July 6th about the efficacy and safety of linzagolix for heavy menstrual bleeding related to uterine fibroids. Dr. Oliver Pohl will present on July 7th regarding the action of oxytocin receptor antagonists in assisted reproductive technology. Both presentations will be accessible via ObsEva's website.
ObsEva SA announced that Yuyuan BioScience Technology has submitted a pre-IND meeting request to the Chinese NMPA for nolasiban, an oral oxytocin receptor antagonist aimed at improving pregnancy and live birth rates during IVF. This marked the initial step for a Phase 1 and 2 study in China, with Yuyuan holding exclusive rights to develop nolasiban there. ObsEva sees potential in nolasiban based on prior clinical data, with the hope it will enhance IVF outcomes. Yuyuan aims to establish nolasiban as a key treatment in a country where IVF procedures are extensive.
ObsEva SA, a clinical-stage biopharmaceutical company, announced the upcoming release of Phase 3 results from the PRIMROSE 1 and PRIMROSE 2 clinical trials on July 6, 2020. These trials focus on the treatment of heavy menstrual bleeding due to uterine fibroids using linzagolix. An investment community conference call is scheduled for the same day at 8 a.m. Eastern Time to discuss the results. ObsEva aims to enhance women's reproductive health through innovative therapies and is listed under the ticker symbol OBSV.
ObsEva SA announced the approval of all Board proposals at its 2020 Annual General Meeting on June 9, 2020. Key approvals included the Annual Report and Financial Statements for FY 2019, discharge for the Board and Executive Committee, re-elections for Board members and the Chairman, as well as re-elections for the Compensation Committee and Auditors. Additionally, shareholders approved increases in Authorized and Conditional Share Capital for Equity Plans, along with changes to the Equity Incentive Plan.
ObsEva SA (NASDAQ: OBSV) published a case report in Fertility and Sterility on its drug, linzagolix, demonstrating significant improvement in a patient with uterine adenomyosis after treatment. The study involved nine women and observed a reduction in uterine volume and alleviation of symptoms over 24 weeks. Linzagolix, taken in two dosing regimens, showed promising efficacy, warranting potential further studies for additional labeling. The unmet medical need for effective long-term therapies for adenomyosis highlights the importance of these findings.
ObsEva SA (NASDAQ: OBSV) reported a net loss of $21.9 million for Q1 2020, improving from $25.7 million in Q1 2019. R&D expenses were $17.2 million, a decrease from $20.1 million year-over-year. Key Phase 3 trials for linzagolix remain on track for results in Q2 2020, while new patient enrollment in EDELWEISS trials is temporarily on hold. The company is actively pursuing commercial partnerships for linzagolix. A Phase 2 PROLONG trial for OBE022 is ongoing, with data expected in 2H 2020. Cash reserves totaled $62 million as of March 31, 2020, down from $69.4 million at the end of 2019.