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
NEG Develops “BDX-3,” a New Starveil™ Ultra-thin Cover Glass for a Wider Range of Space Environments6.10.2026 03:00:00 CEST | Press release
Nippon Electric Glass Co., Ltd. (NEG) (TOKYO: 5214) has developed “BDX-3,” a new Starveil™ ultra-thin cover glass for space applications. BDX-3 is designed to reduce radiation-induced discoloration while providing greater ultraviolet (UV) shielding performance than BDX-2. While primarily intended for low Earth orbit (LEO), it can also be used in medium Earth orbit (MEO) and high Earth orbit, making it suitable for a wider range of space environments. Samples are now available for purchase, and NEG aims to achieve commercial adoption of BDX-3 in satellites and other spaceborne equipment. About BDX-3 Satellites and other equipment operating in space are exposed to intense UV radiation and other forms of radiation. Low Earth orbit is widely used for Earth observation and communications, medium Earth orbit for positioning systems, and high Earth orbit for communications and weather observation. Cover glass used in these environments must not only protect precision equipment from harsh cond
AM Intelligence Expands NVIDIA Vera Rubin AI Factory Buildout in India and Malaysia5.10.2026 20:16:00 CEST | Press release
Two further binding orders of ~20,000 NVIDIA GPUs take AMI's committed NVIDIA Vera Rubin capacity to approximately ~29,000 GPUs and close to 100 MW, part of its global development pipeline of ~400 MW AM Intelligence (“AMI”), the AI infrastructure platform set up by Promoters of Greenko, today announced two further firm and binding orders for 20,000 NVIDIA Rubin GPUs, to be deployed as NVIDIA Vera Rubin NVL72 rack-scale systems. Building on its first AI factory in Hyderabad, the expansion is designed to give cloud providers, enterprises and AI developers access to large-scale computing capacity closer to where they build and deploy AI. These orders are in addition to the AMI's inaugural commitment announced on August 25, 2026, for 9,000 NVIDIA Rubin GPUs at its first AI Factory in Hyderabad. This follow-on capacity totalling ~70 megawatts (MW) will be deployed at Malaysia and India with delivery scheduled for Q2 2027. Taken together, the three orders bring AMI's committed frontier compu
SES Announces Final Results of Its Cash Tender Offer5.10.2026 19:49:00 CEST | Press release
THIS ANNOUNCEMENT RELATES TO THE DISCLOSURE OF INFORMATION THAT QUALIFIED OR MAY HAVE QUALIFIED AS INSIDE INFORMATION WITHIN THE MEANING OF ARTICLE 7(1) OF THE MARKET ABUSE REGULATION (EU) 596/2014. NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION IN OR INTO OR TO ANY PERSON LOCATED OR RESIDENT IN, OR AT ANY ADDRESS IN, THE UNITED STATES OF AMERICA, ITS TERRITORIES AND POSSESSIONS (INCLUDING PUERTO RICO, THE U.S. VIRGIN ISLANDS, GUAM, AMERICAN SAMOA, WAKE ISLAND AND THE NORTHERN MARIANA ISLANDS), ANY STATE OF THE UNITED STATES OF AMERICA OR THE DISTRICT OF COLUMBIA (THE UNITED STATES) OR TO ANY U.S. PERSON (AS DEFINED IN REGULATION S OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED (THE SECURITIES ACT)) OR IN OR INTO ANY JURISDICTION WHERE IT IS UNLAWFUL TO RELEASE, PUBLISH OR DISTRIBUTE THIS ANNOUNCEMENT. SES (the “Offeror”) announces today the final results and pricing of its invitation to holders of its outstanding €500,000,000 0.875 per cent. Guaranteed Notes due 4 November 2027
Cessna Skyhawk Veris Virtual Reality Flight Training Device to Make Show Debut at NBAA-BACE in Las Vegas5.10.2026 17:00:00 CEST | Press release
Attendees can experience how the dual-seat Cessna Skyhawk Veris brings instructors and students together for realistic, immersive flight training TRU Simulation + Training Inc., a Textron Inc. (NYSE:TXT) company, and an affiliate of Textron Aviation, announced today its Veris Virtual Reality Flight Training Device (FTD) configured for the Cessna Skyhawk is making its show debut at the 2026 National Business Aviation Association Business Aviation Convention & Exhibition (NBAA-BACE). The show debut builds on momentum from NBAA-BACE 2025, where TRU Simulation announced a purchase agreement with US Aviation Academy for five Cessna Skyhawk Veris devices, with options for additional units. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261005927782/en/ Cessna Skyhawk Veris Virtual Reality Flight Training Device to make show debut at NBAA-BACE in Las Vegas This year, NBAA-BACE attendees will have the opportunity to experience the C
FuzeBox AI Named Founding Co-Author of SPUR Coalition Technical Committee on Verifying AI Content Use5.10.2026 15:00:00 CEST | Press release
A new technical committee will define how publishers can independently confirm AI companies' reports of content use. FuzeBox AI has been named by the SPUR Coalition, an international nonprofit of 37 news and media organizations, as one of four founding co-authors of its Evidence Profile Technical Committee, adopted Sept. 2, 2026, to draft an evidence profile for SPUR's Content Telemetry standard: a way for publishers to verify AI usage reports without depending on the reporting company's cooperation. Under SPUR's current standard, AI companies self-report their content use. A company that skips reporting leaves no record, and publishers can't check what they do receive. On July 10, 2026, FuzeBox proposed its Verified Provenance Telemetry Standard (VPTS): publishers seed content with detectable markers, then verify their appearance in AI outputs via an auditable ledger, with no change to SPUR's standard. Within 48 hours, three organizations filed related proposals: ProRata on usage magn
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