OBSV - OBSV STOCK NEWS

ObsEva SA has announced its final 76-week results from the PRIMROSE 1 clinical study for Yselty, a treatment for heavy menstrual bleeding due to uterine fibroids. The results confirm previous findings from PRIMROSE 2, showcasing sustained post-treatment effects and evidence of bone mineral density recovery. Yselty offers unique dosing options, including a low-dose regimen. The US NDA submission is on track for Q3 2021, while an EU MAA recommendation is expected in Q4 2021. The data enhances Yselty's profile as a potential best-in-class therapy.

ObsEva SA (NASDAQ: OBSV) reported a net loss of $20 million for Q1 2021, improving from a $21.9 million loss in Q1 2020. R&D expenses totaled $15.5 million, down from $17.2 million year-over-year. Significant milestones include the planned submission of a U.S. New Drug Application (NDA) for Yselty for uterine fibroids in Q3 2021, with a European marketing approval recommendation expected in Q4 2021. The company also aims to initiate a Phase 2b trial for Ebopiprant in Q4 2021. Cash reserves stood at $68 million, bolstered by a $60 million equity raise earlier this year.

ObsEva has announced the appointment of Clive Bertram as Chief Commercial Officer, effective May 10, 2021. He replaces Wim Souverijns, who will leave on June 30, 2021. Bertram brings 30 years of experience in the pharmaceutical industry and will play a crucial role in the commercialization of the company's lead product, Yselty, targeting uterine fibroids. The transition aims to strengthen investor relations as ObsEva prepares for the EU launch of Yselty and a new drug application in the U.S.

ObsEva SA has completed enrollment for the Phase 3 EDELWEISS 3 trial of Yselty® targeting moderate to severe endometriosis-associated pain, with top-line data expected in Q4 2021. This trial is crucial as it aims to provide better long-term treatment options for the approximately 176 million women affected globally. The Phase 2b trial indicated that linzagolix significantly improved symptoms for patients without decreasing bone mineral density. This successful milestone builds on the positive data from earlier trials and reflects the company's commitment to women's reproductive health.

ObsEva SA (NASDAQ: OBSV) announced the presentation of five e-Posters on linzagolix at the ACOG Annual Clinical and Scientific Meeting from April 30 to May 2, 2021. The data showcased linzagolix's potential as a best-in-class treatment for heavy menstrual bleeding (HMB) due to uterine fibroids, further validating results from the PRIMROSE Phase 3 program. Key findings included significant reductions in uterine and fibroid volumes, pain relief, and improvements in hemoglobin levels in anemic patients. The safety profile also aligns with prolonged usage.

ObsEva SA has initiated the PRIMROSE 3 observational study to evaluate long-term bone mineral density (BMD) in women who completed at least 20 weeks of treatment in the Phase 3 studies PRIMROSE 1 and 2. The study will enroll over 300 eligible participants and assess BMD using DXA scans up to 24 months post-treatment. The CEO expressed optimism over the anticipated results, which follow positive data regarding the treatment's efficacy and tolerability. Yselty, a GnRH receptor antagonist for uterine fibroids, is still awaiting regulatory approval.

ObsEva SA (NASDAQ: OBSV) has announced its 2021 Annual General Meeting of Shareholders to be held on May 28, 2021, in Geneva. The agenda includes the approval of financial statements for fiscal year 2020, where the company reported a net loss of USD 75,216,317, increasing total accumulated losses to USD 328,451,570. The board recommends discharging the executive committee from liability for their actions in 2020. Additionally, several board members are up for re-election, including Franciscus Verwiel as Chairman.

ObsEva SA (NASDAQ: OBSV) reported its 2020 financial results, marking a pivotal year in transitioning from a clinical stage to preparing for commercialization. The company plans to file a New Drug Application (NDA) for Yselty® for uterine fibroids in Q2:21 and anticipates European approval in Q4:21. It also expects Phase 3 EDELWEISS 3 study results for endometriosis in Q4:21 and will initiate a Phase 2b study for ebopiprant. The cash position at year-end was $31.2 million, with recent funding increasing this to $86.8 million. Net loss was $83 million, showing improvement from $108.8 million in 2019.

ObsEva announced on March 3, 2021, that its management team will provide a corporate update during the H.C. Wainwright Global Life Sciences Conference, held on March 9-10, 2021. The presentation will be available on-demand via the conference portal starting at 7 a.m. EST on March 9. ObsEva focuses on developing novel therapies to enhance women's reproductive health, with a late-stage clinical pipeline targeting endometriosis, uterine fibroids, and preterm labor. The company is publicly traded on NASDAQ under the symbol OBSV.