OBSV - OBSV STOCK NEWS

ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company focused on women's reproductive health, announced a corporate update presentation during the H.C. Wainwright BioConnect Conference from January 10-13, 2022. The presentation will be available on-demand starting at 7 a.m. EST on January 10, 2022. Additionally, a webcast will be accessible after the event on the company's website under Events Calendar. ObsEva is advancing therapies for uterine fibroids, endometriosis, and preterm labor.

ObsEva has announced its addition to the NASDAQ Biotechnology Index, effective December 20, 2021. This milestone is expected to enhance the company's visibility among investors and broaden its audience. CEO Brian O’Callaghan highlighted significant achievements in clinical and regulatory milestones over the past year. The NASDAQ Biotechnology Index includes securities from biotechnology and pharmaceutical companies, tracked by investment managers and institutional investors. ObsEva is focused on developing therapies for women's reproductive health.

ObsEva SA, a biopharmaceutical firm focused on women's reproductive health, announced its inclusion in the NASDAQ Biotechnology Index effective December 20, 2021. CEO Brian O’Callaghan expressed pride in this achievement, highlighting the company’s progress in clinical and regulatory milestones. The NASDAQ Biotechnology Index serves as a benchmark for investment managers, tracking the performance of biotechnology and pharmaceutical securities. ObsEva's late-stage clinical pipeline targets treatments for uterine fibroids, endometriosis, and preterm labor.

ObsEva SA announced a positive opinion from the CHMP of the EMA recommending approval for linzagolix, an oral GnRH antagonist for managing moderate to severe symptoms of uterine fibroids in women of reproductive age. This decision follows the acceptance of a New Drug Application by the FDA. If approved, linzagolix will be the first non-hormonal GNRH antagonist available. The final decision from the European Commission is expected in the next two months. The positive opinion is based on successful data from Phase 3 PRIMROSE trials.

ObsEva SA announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval for linzagolix, an oral GnRH antagonist for treating moderate to severe uterine fibroids in women of reproductive age. The recommendation is based on positive data from two Phase 3 trials, PRIMROSE 1 and PRIMROSE 2, showing significant efficacy. A final decision from the European Commission is expected within two months, following the recent acceptance of the NDA by the U.S. FDA.

ObsEva SA (NASDAQ: OBSV) announced the appointment of Will Brown as Chief Financial Officer, effective January 1, 2022. Brown, a seasoned biopharmaceutical executive, has a proven track record in business development and finance, previously serving as CFO at Altimmune, Inc. His role comes amid significant developments for ObsEva, including the NDA acceptance of linzagolix by the FDA, which has the potential to be a breakthrough therapy for uterine fibroids. This leadership change aims to enhance the company's strategic direction and drive long-term value for shareholders.

ObsEva SA (NASDAQ: OBSV) announced upcoming presentations of its linzagolix clinical development program at the SEUD Congress, focusing on uterine fibroids and endometriosis. Key results from Phase 3 PRIMROSE studies show linzagolix demonstrated significant efficacy in reducing heavy menstrual bleeding (HMB) with improvements maintained at 52 weeks. Additionally, long-term data indicates bone mineral density recovery in endometriosis patients. The symposium highlights the potential of personalized therapeutic approaches for managing uterine fibroids.

ObsEva SA (NASDAQ: OBSV) announced its participation in the 7th SEUD Congress on December 2, 2021. The company will feature a symposium focusing on linzagolix, an oral GnRH antagonist, scheduled for December 10, 2021. Key presentations include results from a Phase 2b trial on Bone Mineral Density recovery in women with endometriosis and Phase 3 trial results on the efficacy and safety of linzagolix for heavy menstrual bleeding due to uterine fibroids. These presentations aim to highlight the potential benefits of linzagolix in addressing unmet needs in women's health.

ObsEva SA announced the acceptance of its New Drug Application (NDA) for linzagolix, targeting heavy menstrual bleeding associated with uterine fibroids in premenopausal women. The FDA review is based on positive results from Phase 3 PRIMROSE trials. If approved, linzagolix could be the first GnRH receptor antagonist offering flexible dosing options. The FDA's target action date is September 13, 2022. Additionally, the European marketing authorization application is progressing, with a recommendation expected in Q4 2021.