THERAMEX
17.6.2022 12:45:04 CEST | Business Wire | Press release
The European Commission (EC) has granted Marketing Authorization for Yselty® (linzagolix), an oral GnRH antagonist, indicated for the treatment of moderate to severe symptoms of Uterine Fibroids (UF) in adult women (over 18 years of age) of reproductive age. This announcement is in partnership with ObsEva SA (Nasdaq: OBSV), a biopharmaceutical company developing and commercializing novel therapies for women’s health.
The EC decision follows the Committee for Medicinal Products for Human Use (CHMP) confirmation of positive opinion in April 2022.
Linzagolix ® is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF. Yselty® is approved in the EU at the following doses:
- 100 mg or 200 mg once daily with hormonal ABT, with no limitation in treatment duration
- 100 mg once daily for women in whom ABT is not recommended or who prefer to avoid hormonal therapy, with no limitation in treatment duration
- 200 mg once daily for short-term use (< 6 months) in clinical situations when reduction of uterine and fibroid volume is desired
The approval is based on positive data from the ObsEva’s two Phase 3 PRIMROSE trials.
“Uterine Fibroids affect 25% of women within reproductive age, many with severe symptoms requiring surgery. With the approval of Linzagolix we can potentially offer a new treatment option for physicians in managing women with uterine fibroids to provide symptomatic relief and delay or avoid surgery. Additionally, we will continue to work with our partner ObsEva for follow-on indications, such as endometriosis, another area of women’s health with limited treatment options. This marks an important therapeutic extension for Theramex to widen our portfolio and provide gynaecologist’s support for unmet medical needs,” said Robert Stewart, Theramex CEO.
“As the first and only approved GnRH antagonist to provide flexible dosing options with and without hormonal add-back therapy, Yselty® has the potential to transform the treatment paradigm and significantly advance medical options for women in the EU with uterine fibroids,” said Dr. Brandi Howard, Chief Clinical Officer of ObsEva. “We are pleased to be the first to provide women and doctors with a non-hormonal dosing option for the millions of women who either have contraindications to or a personal preference to avoid the use of hormonal add-back therapy, while also providing dosing options for women for whom hormonal add-back therapy is appropriate.”
In February 2022, Theramex entered into a strategic licensing agreement with Obseva, a leading biopharmaceutical company in novel therapies, to commercialize and market the introduction of linzagolix across international markets outside of the U.S., Canada, and Asia.
About Yselty® (linzagolix)
Linzagolix is a once daily, oral GnRH receptor antagonist developed to offer flexible dosing options with and without hormonal add-back therapy to women suffering from uterine fibroids and is approved in the EU.
About Theramex
Theramex is a leading global speciality pharmaceutical company dedicated to women and their health. Theramex supports women at different stages of their lives by providing a broad portfolio of innovative and established brands covering contraception, fertility, menopause and osteoporosis. Theramex’s commitment is to listen to and understand its patients, serve their needs and offer healthcare solutions to help improve their lives. Theramex’s vision is to be a lifetime partner for women and the healthcare professionals who treat them by providing patient-focused and effective solutions that care for and support women through different stages of their life.
About ObsEva
ObsEva is a biopharmaceutical company developing and commercializing novel therapies to help improve women’s reproductive health and pregnancy. The Company’s first approved drug is Yselty® (linzagolix), which is approved in the EU. ObsEva is listed on the Nasdaq Global Select Market and is traded under the ticker symbol “OBSV” and on the SIX Swiss Exchange where it is traded under the ticker symbol “OBSN”.
For more information, please visit www.ObsEva.com
About Kissei
Linzagolix has been discovered by Central Research Laboratories of Kissei Pharmaceutical Co., Ltd. Kissei is a Japanese pharmaceutical company based on the management philosophy “contributing to society through high-quality, innovative pharmaceutical products” and “serving society through our employees.” As a strong R&D-oriented corporation, it concentrates on providing innovative pharmaceuticals to patients worldwide in the focus fields of urology, nephrology/dialysis, gynaecology and rare/intractable diseases.
Yselty_HQ_PRESSR_007649 D.O.P: 17/06/22
View source version on businesswire.com: https://www.businesswire.com/news/home/20220617005176/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Mobix Labs Signs Definitive Agreement to Acquire Vision Aerial, Accelerating Global Drone Platform for National Security and Aerial Intelligence24.7.2026 13:00:00 CEST | Press release
Transaction accelerates Mobix Labs’ global aerial intelligence strategy and National Security Matters Initiative Mobix Labs, Inc. (Nasdaq: MOBX) today announced that it has signed a definitive agreement to acquire Vision Aerial, Inc., a U.S.-based designer and manufacturer of American-built, National Defense Authorization Act (NDAA)-compliant unmanned aerial systems. The definitive agreement moves the transaction beyond the previously announced letter of intent and represents a major step toward closing an acquisition that would expand Mobix Labs into one of the world’s most important technology growth markets: secure drones, autonomous aerial systems and aerial intelligence for national security, critical infrastructure, energy, public safety, industrial inspection and government operations. Vision Aerial’s customers and end-users include the U.S. Air Force, U.S. Navy, government agencies, energy and utility operators, research institutions and other organizations requiring performanc
Enhertu® Plus Pertuzumab Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with HER2 Positive Metastatic Breast Cancer24.7.2026 13:00:00 CEST | Press release
Recommendation based on DESTINY-Breast09 phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% versus THP with a median progression-free survival exceeding three years If approved, Daiichi Sankyo and AstraZeneca’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for first-line HER2 positive metastatic breast cancer Enhertu® (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the first-line treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+ or in-situ hybridization [ISH]+) breast cancer. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP)
SLB Announces Second-Quarter 2026 Results24.7.2026 12:50:00 CEST | Press release
Revenue of $8.97 billion increased 3% sequentially and 5% year on year GAAP EPS of $0.52 increased 4% sequentially and decreased 30% year on year EPS, excluding charges and credits, of $0.55 increased 6% sequentially and decreased 26% year on year Net income attributable to SLB of $786 million increased 5% sequentially and decreased 22% year on year Adjusted EBITDA of $1.90 billion increased 7% sequentially and decreased 7% year on year Cash flow from operations was $1.36 billion and free cash flow was $716 million Board approved quarterly cash dividend of $0.295 per share SLB (NYSE: SLB) today announced results for the second-quarter 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260722694386/en/ The exterior of the SLB headquarters in Houston, Texas.Second-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChangeJun. 30, 2026Mar. 31, 2026Jun. 30, 2025SequentialYear-on-yearRevenue $8,972 $8
NIQ Expands GenAI Capabilities Across gfknewron, Turning Trusted Intelligence into Decisions Faster24.7.2026 12:30:00 CEST | Press release
New capabilities help businesses uncover trends faster, simplify complex analysis, and accelerate confident decision-making NIQ (NYSE: NIQ), a leader in consumer intelligence, today announced the expansion of AI-powered Smart Insights across its gfknewron® platform. By bringing together markets and categories into a single view, gfknewron enables businesses to transform complex market, consumer and supply chain data into clear, actionable intelligence quickly. The latest enhancements help users identify trends, opportunities and performance drivers more quickly, reducing the time required to analyze large datasets and accelerating confident decision-making across teams. As brands and retailers face growing pressure to respond quickly to changing consumer behavior and market dynamics, the ability to unlock meaningful insights from increasingly rich datasets has become a significant competitive advantage. As AI is only as effective as the intelligence behind it, Smart Insights helps busi
Thales to Strengthen Romania’s Airspace Protection With Twelve Ground Master 200 MM/A Radars24.7.2026 10:05:00 CEST | Press release
The Romanian General Directorate for Armaments and the French Direction Générale de l’Armement (DGA – the French defence procurement agency) have signed an agreement to supply twelve Thales GM200 Multi-Mission All-in-one (GM200 MM/A) radars to protect the Romanian airspace. This government-to-government agreement underlines the high level of partnership between France and Romania, within the framework of the European Union’s SAFE funding programme, in order to bolster Europe’s defence capabilities. The GM200 MM/A is part of Thales’ proven Ground Master radar family, which has already been deployed in over 40 countries, including now in Romania. In a context of growing collaboration between European nations to bolster collective security, the Romanian General Directorate for Armaments has just signed a landmark agreement with France’s Direction Générale de l’Armement (DGA) to acquire twelve Thales Ground Master 200 Multi-Mission All-in-one (GM200 MM/A) radars. This government-to-governm
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom