OBSV - OBSV STOCK NEWS

ObsEva SA reported a net income of $0.8 million, or $0.01 per share, for Q3 2021, a significant improvement from a net loss of $24.4 million, or $0.49 per share, in Q3 2020. R&D expenses decreased to $11.5 million from $20.1 million year-over-year. The company is advancing its drug linzagolix for uterine fibroids and endometriosis, with regulatory approvals expected in Q4 2021. Additionally, a global license agreement for ebopiprant was completed with Organon. Cash and equivalents stood at $62.9 million as of September 30, 2021, up from $31.2 million at the end of 2020.

ObsEva SA announces the resignation of CFO David Renas, effective January 5, 2022, for personal reasons. The company has engaged an executive search firm to find a successor. CEO Brian O’Callaghan expressed gratitude for Renas's contributions over the past year. ObsEva focuses on developing therapies for women's reproductive health, with an advanced clinical pipeline targeting uterine fibroids, endometriosis, and preterm labor. The company is publicly traded on NASDAQ under the symbol OBSV.

ObsEva SA announced the presentation of clinical data for linzagolix, a GnRH antagonist, at the ASRM 2021 Congress. The Phase 3 PRIMROSE 1 and 2 studies showed that linzagolix 200 mg reduced uterine volume by 39% at 24 weeks but effects diminished by week 52 when combined with hormonal add-back therapy. In a pilot study for severe adenomyosis, high-dose linzagolix (200 mg) led to a 55% reduction in uterine volume at 12 weeks. Safety results indicated manageable side effects with no serious adverse events reported.

ObsEva SA (NASDAQ: OBSV) announced two poster presentations on linzagolix at the ASRM 2021 Scientific Congress, scheduled for October 20, 2021. One presentation will discuss the efficacy and safety of linzagolix for severe adenomyosis, featuring results from a pilot study. The second will address how hormonal add-back therapy affects uterine volume during GnRH antagonist therapy. Both presentations will be available via the conference portal, enhancing ObsEva's visibility in women's reproductive health therapies.

ObsEva has partnered with Syneos Health to commercialize Linzagolix, an oral GnRH antagonist pending regulatory approval in the U.S. and Europe for uterine fibroids treatment. This collaboration aims to leverage Syneos Health’s expertise in women’s health to maximize product value. ObsEva also announced a $135 million financing agreement with JGB Management to support the launch and operational costs. Additionally, they amended the license agreement with Kissei, extending commercial milestones and adjusting royalty payments.

ObsEva announced the appointment of Luigi Marro as Chief Transformation Officer, effective October 1, 2021. Marro, a seasoned executive with over 20 years in the pharmaceutical industry, will lead the company's strategic initiative for commercial operational readiness. His extensive experience in reproductive health and financial expertise is expected to support the regulatory approval and commercialization of linzagolix, aimed at treating heavy menstrual bleeding and pain associated with uterine fibroids in pre-menopausal women.

ObsEva SA has submitted a New Drug Application (NDA) to the FDA for linzagolix, an oral GnRH receptor antagonist aimed at treating uterine fibroids. If approved, linzagolix will offer flexible dosing options, making it unique in the market. The Phase 3 PRIMROSE trials reported positive results, showing significant reductions in heavy menstrual bleeding over 52 weeks. The company awaits an EMA recommendation for marketing approval by Q4 2021. This submission marks a critical step toward addressing women's health needs in this area.

ObsEva SA (NASDAQ: OBSV; SIX: OBSN) announced a corporate update and investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be accessible on-demand from 7:00 a.m. ET on September 13, via the conference portal. ObsEva focuses on developing therapies for women’s reproductive health, with a late-stage clinical pipeline addressing issues like endometriosis and preterm labor.

ObsEva SA (NASDAQ: OBSV) reported its Q2 2021 financial results, revealing a net loss of $19.1 million or $0.25 per share, compared to a loss of $18.2 million or $0.38 per share in Q2 2020. The company focuses on advancing linzagolix for uterine fibroids and endometriosis, with a U.S. New Drug Application submission planned for Q3 2021. A global license agreement for ebopiprant was completed with Organon. As of June 30, 2021, ObsEva held $58.9 million in cash and cash equivalents, significantly up from $31.2 million at year-end 2020.