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ObsEva SA is a biopharmaceutical company based in Plan-les-Ouates, Switzerland, specializing in the development and commercialization of novel therapies to enhance women's reproductive and pregnancy health. Founded in 2012, ObsEva is dedicated to addressing unmet needs in reproductive medicine by focusing on innovative treatments that aim to improve fertility outcomes and manage preterm labor.

Currently, ObsEva is involved in several key projects, including their lead product linzagolix, an oral GnRH antagonist designed to treat uterine fibroids and endometriosis. This medication aims to offer significant benefits over existing treatments by providing symptom relief with fewer side effects.

ObsEva's approach is underscored by a robust pipeline and strategic partnerships with leading healthcare organizations. Financially, the company continues to navigate its path with a focus on securing funding to propel its clinical trials and regulatory submissions. Recently, ObsEva has made significant strides with positive results from their Phase 3 trials for linzagolix, putting them on track for potential market approval.

ObsEva's commitment to innovation and patient health is reflected through its continuous efforts in research and development, making significant progress in areas with high medical needs. The company's forward-looking strategy is built on scientific rigor, collaborative partnerships, and a deep understanding of women's health issues.

For more information, please contact:
General inquiries: contact@obseva.ch
Investor relations: IR@obseva.ch

ObsEva SA
Chemin des Aulx 12,
1228 Plan-les-Ouates,
Switzerland

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ObsEva SA presented data from the PRIMROSE Phase 3 studies on linzagolix for treating heavy menstrual bleeding linked to uterine fibroids at the ACOG Annual Meeting. Results showed linzagolix improved health-related quality of life, hemoglobin levels, and had a low incidence of adverse effects like alopecia and mood disorders. The drug offers unique dosing options and, if approved, could become the only oral GnRH antagonist with non-hormonal options. The studies included 1,109 women and indicate promising long-term benefits.

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ObsEva SA announces the appointment of Dr. Brandi Howard as Chief Clinical Officer, effective May 9, 2022. Dr. Howard, with over 20 years in women's health, succeeds Dr. Elizabeth Garner, who departs on May 6, 2022. Dr. Howard's role involves leading clinical development strategies as ObsEva prepares for potential product approvals in 2022, particularly for linzagolix targeting uterine fibroids. CEO Brian O’Callaghan emphasizes her expertise as a strong asset during this pivotal time for the company aimed at addressing unmet needs in women's health.

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ObsEva has announced the appointment of Dr. Brandi Howard as Chief Clinical Officer, effective May 9, 2022. Dr. Howard, with over 20 years of experience in women's health, succeeds Dr. Elizabeth Garner, who departs to pursue other opportunities. Garner will assist ObsEva as a consultant. Under Dr. Howard's leadership, the company aims to advance its product pipeline, particularly the anticipated approval of linzagolix for uterine fibroids in the coming months. This leadership change comes at a critical time as ObsEva transitions towards becoming a commercial-stage company.

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ObsEva SA announced a confirmed positive opinion from the European Medicines Agency (EMA)'s CHMP for linzagolix to treat uterine fibroids. This recommendation follows the initial positive stance from December 2021. If approved by the European Commission, linzagolix would be the first approved oral GnRH antagonist with a non-hormonal dosing option for women who cannot or choose not to take hormones. The company has partnered with Theramex for commercialization in Europe and with Syneos Health for the U.S. market, where a decision from the FDA is expected by September 2022.

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ObsEva SA announced on April 25, 2022, that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) confirmed its positive opinion for linzagolix to treat uterine fibroids (UF). Linzagolix, if approved by the European Commission, will be the first oral GnRH antagonist offering a non-hormonal option for women not wanting hormone treatment. ObsEva partnered with Theramex for commercialization in Europe and with Syneos Health for its U.S. launch, with a PDUFA date set for September 13, 2022.

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ObsEva SA (NASDAQ: OBSV/SIX: OBSN) announced its 2022 Annual General Meeting (AGM) scheduled for May 18, 2022, in Geneva. Key agenda items include approving the 2021 Annual Report and financial statements, discharging Board and Executive Committee members from liability, and addressing the company's loss of USD 55.48 million. Notable proposals include re-electing members of the Board and increasing authorized share capital to 54.31 million shares. Shareholder approval is sought for compensation plans totaling USD 17.5 million for Board and Executive members.

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ObsEva SA (NASDAQ: OBSV / SIX: OBSN) has announced its 2022 Annual General Meeting scheduled for May 18, 2022, at its Geneva office. Key agenda items include the approval of financial statements for FY 2021, re-elections of board members, and increases in authorized and conditional share capital. The company reported a net loss of USD 55.48 million for 2021, raising total accumulated losses to USD 383.93 million. The proposals also cover compensation changes for the board and executive committee, along with the re-election of auditors.

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ObsEva SA has released its Annual Report 2021 to Shareholders, detailing the company's developments in women's reproductive health. The report can be accessed via their website. ObsEva is focused on developing therapies for uterine fibroids, endometriosis, and preterm labor. The company utilizes strategic in-licensing and disciplined drug development, and is listed on both NASDAQ under the ticker OBSV and the SIX Swiss Exchange as OBSN.

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ObsEva SA has published its Annual Report 2021 to Shareholders on March 31, 2022. The report details the company’s progress in developing therapies aimed at improving women’s reproductive health and pregnancy. ObsEva is focused on treating uterine fibroids, endometriosis, and preterm labor, bolstered by a late-stage clinical pipeline. The report is accessible on their website. For additional inquiries, the CEO and investor contacts are provided.

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ObsEva SA (NASDAQ: OBSV) announced promising results from the Phase 3 EDELWEISS 3 trial of linzagolix, a GnRH antagonist for treating endometriosis-associated pain. After 6 months, both co-primary endpoints, reductions in dysmenorrhea (DYS) and non-menstrual pelvic pain (NMPP), showed significant improvement compared to placebo. Secondary endpoints also demonstrated symptom relief. Notably, the treatment improved patients' quality of life and reduced the inclination for surgical intervention. Further results and developments in the study are anticipated in late 2022.

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FAQ

What is ObsEva SA's core business?

ObsEva SA specializes in developing therapies for women's reproductive and pregnancy health.

Where is ObsEva SA headquartered?

ObsEva SA is headquartered in Plan-les-Ouates, Switzerland.

What is linzagolix?

Linzagolix is an oral GnRH antagonist developed by ObsEva to treat uterine fibroids and endometriosis.

How can I contact ObsEva for general information?

You can contact ObsEva at contact@obseva.ch for general inquiries.

How can investors get in touch with ObsEva?

Investors can reach out to ObsEva at IR@obseva.ch.

What are some recent achievements of ObsEva?

ObsEva has reported positive results from their Phase 3 trials for linzagolix, positioning them for potential market approval.

Does ObsEva have any strategic partnerships?

Yes, ObsEva collaborates with leading healthcare organizations to advance their research and development efforts.

What is the focus of ObsEva's research and development?

ObsEva focuses on innovative treatments to improve fertility outcomes and manage preterm labor.

How does linzagolix differ from existing treatments?

Linzagolix aims to provide symptom relief for uterine fibroids and endometriosis with fewer side effects compared to existing treatments.

What is ObsEva's commitment to women's health?

ObsEva is dedicated to addressing unmet needs in reproductive medicine through rigorous scientific research and innovative therapies.

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Medicinal and Botanical Manufacturing
Manufacturing
Link
Switzerland
Plan Les Ouates