Welcome to our dedicated page for OBSV news (Ticker: OBSV), a resource for investors and traders seeking the latest updates and insights on OBSV stock.
ObsEva SA (OBSV) is a clinical-stage biopharmaceutical company pioneering novel therapies for women's reproductive health challenges. This comprehensive news hub provides essential updates on their therapeutic pipeline, clinical milestones, and strategic initiatives.
Investors and healthcare professionals will find timely information about linzagolix development progress, including regulatory submissions and trial data analysis. The resource also covers partnership announcements, financial updates, and scientific presentations relevant to uterine fibroid treatments and endometriosis care.
Key content areas include detailed reports on Phase 3 clinical trial outcomes, FDA/EMA regulatory communications, intellectual property developments, and market access strategies. All information is sourced directly from company filings and verified medical publications to ensure accuracy.
Bookmark this page for structured access to ObsEva's latest advancements in GnRH antagonist research and women's health solutions. Check regularly for updates on their mission to transform reproductive medicine through targeted therapeutic innovation.
GENEVA, Switzerland – July 27, 2022 – ObsEva SA (NASDAQ: OBSV; SIX: OBSN) announced a corporate restructuring to address FDA review issues concerning its New Drug Application (NDA) for linzagolix, aimed at treating uterine fibroids. The company plans to terminate its license agreement with Kissei and apply for a moratorium in Switzerland to protect against debt enforcement. The restructuring will refocus on existing agreements with Organon and Yuyuan BioScience for ebopiprant and nolasiban, respectively. These changes aim to secure the company’s financial stability amid ongoing FDA negotiations.
ObsEva SA (NASDAQ: OBSV; SIX: OBSN) has announced the immediate resignation of Fabien de Ladonchamps from its Executive Committee, although he will continue as a senior management member. The biopharmaceutical company focuses on developing therapies for women’s reproductive health and pregnancy, particularly targeting preterm labor and improving live birth rates following IVF.
ObsEva emphasizes its commitment to drug development through strategic partnerships and has a pipeline that includes ongoing clinical trials and strategic collaborations.
ObsEva has received marketing authorization from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Yselty® (linzagolix), the first and only approved oral GnRH antagonist with flexible dosing options for moderate to severe symptoms of uterine fibroids in women of reproductive age. Following the European Commission's prior approval, Yselty® offers non-hormonal options and has a favorable efficacy and tolerability profile. Theramex will commercialize Yselty®, while ObsEva will earn royalties and milestone payments.
ObsEva SA has received marketing authorization from the European Commission for Yselty® (linzagolix), designed to treat moderate to severe symptoms of uterine fibroids in women over 18. This approval follows a positive recommendation from the European Medicines Agency in April 2022. Yselty® is notable for its flexible dosing options, available with and without hormonal add-back therapy. ObsEva will receive royalties and milestone payments from Theramex, which will commercialize Yselty® in Europe. The FDA is currently reviewing its NDA, with a decision expected by September 13, 2022.
The European Commission (EC) has granted Marketing Authorization for Yselty® (linzagolix), a novel oral GnRH antagonist for treating moderate to severe symptoms of Uterine Fibroids in women over 18. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use in April 2022. Yselty® offers flexible dosing options with and without hormonal therapy. Approval is based on data from two Phase 3 PRIMROSE trials. ObsEva SA partnered to commercialize Yselty® across international markets.
ObsEva announced the European Commission's marketing authorization for Yselty® (linzagolix), the first approved oral GnRH antagonist for managing moderate to severe symptoms of uterine fibroids in women over 18. The approval follows a positive opinion from the European Medicines Agency and is valid across 27 EU countries, Iceland, Norway, and Liechtenstein. ObsEva has a strategic licensing agreement with Theramex for commercialization, entitling ObsEva to royalties and milestone payments. The New Drug Application for Yselty® is under review by the FDA, with a PDUFA target date of September 13, 2022.
ObsEva has entered a waiver and amendment agreement with JGB Management regarding its securities purchase agreement, which offers up to $135 million borrowing capacity through nine tranches. The third tranche, due May 25, 2022, was not funded as ObsEva's share price fell below $3.00 for the requisite trading days. JGB waived its termination rights, allowing future funding, but ObsEva faces further restrictions on its control agreements. The fourth tranche is due by August 23, 2022.
ObsEva SA presented new clinical data on linzagolix, an oral GnRH antagonist, at two major congresses. At the 8th Society of Endometriosis and Uterine Disorders Congress, the drug showed significant reduction in heavy menstrual bleeding in non-responders. In the EDELWEISS 3 trial, linzagolix improved pain symptoms associated with endometriosis. The trials involved extensive patient populations and demonstrated strong efficacy, supporting further development. Both trials are critical for obtaining regulatory approval, with future data expected in mid-2022 and early 2023.
ObsEva SA presented promising clinical data on linzagolix, an oral GnRH antagonist, at various medical congresses, including the 8th Society of Endometriosis and Uterine Disorders Congress and the International Society of Gynecological Endocrinology Congress.
Key findings showed significant reductions in heavy menstrual bleeding and endometriosis-associated pain in clinical trials. Results indicated a substantial proportion of non-responders still achieved objective measures of reduced bleeding after treatment, underscoring linzagolix's potential in treating women's health issues.
ObsEva SA has appointed Annette Clancy as the new Chair of the Board of Directors, effective following the Annual General Meeting on May 18, 2022. Clancy, who has been a board member since 2013 and previously served as Chair, succeeds Dr. Frank Verwiel, who is retiring. Clancy brings over 30 years of pharmaceutical experience, notably at GlaxoSmithKline, and is expected to lead the company during its transition to a commercial-stage entity. The company is preparing for the potential approval of its drug linzagolix for women's health.
