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
LabGenius Therapeutics and LG Chem Enter a Research Collaboration, Option and License Agreement to Develop an AI/ML-Designed Tumour-Targeting Antibody18.6.2026 01:01:00 CEST | Press release
The companies have entered into a multi-year research collaboration, option and licensing agreement in which LabGenius Therapeutics will leverage its AI/ML-driven antibody discovery platform,EVA™, to design and engineer next-generation multispecifics with enhanced therapeutic properties LabGenius Therapeutics will receive an undisclosed upfront payment and potential early milestones, plus, if the option is exercised, potential triple-digit million clinical, regulatory, and commercial milestones, along with royalties on net sales LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise therapeutic antibodies, today announced a multi-year research collaboration, option and licensing agreement with LG Chem. The collaboration aims to identify next-generation multispecific antibodies designed to overcome the key limitations of existing immunotherapies, including on-target, off-tumour toxicities. Together,
Joe Vernachio Named President of SOREL18.6.2026 00:00:00 CEST | Press release
Columbia Sportswear Company (Nasdaq: COLM), a leading innovator in active outdoor apparel, footwear, accessories and equipment, today announced that Joe Vernachio will be the next President of SOREL. Founded in 1962, SOREL is a leader in functional and lifestyle footwear that can be worn anywhere from the tundra to the streets of New York City. “We’re excited to welcome Joe Vernachio back to the Columbia Sportswear family,” said Tim Boyle, CEO and Chair of the Board. “Joe is a terrific leader who can build on the great work, talent and momentum in place at SOREL.” Mr. Vernachio led the Mountain Hardwear brand for several years, until he left to become the COO and ultimately, the CEO of Allbirds. His background also includes time as Global Vice President for Product and Operations at The North Face, and key roles at Nike, Spyder, Roots, Calvin Klein and Patagonia. “Joe is a consumer‑focused, collaborative leader with a deep passion for product and brand storytelling. His energy, experti
Venture Global and EnBW Announce New LNG Purchase Agreements17.6.2026 22:30:00 CEST | Press release
Today, Venture Global, Inc. (NYSE: VG) and EnBW announced the execution of new, binding agreements for the purchase of approximately 0.82 million tonnes per annum (MTPA) of U.S. liquefied natural gas (LNG) from Venture Global for approximately five years commencing in 2026, to be supplied from Venture Global’s portfolio. The new agreements add to the existing long-term sales and purchase agreements (SPAs) between Venture Global and EnBW for 2 MTPA for 20 years. “As one of Germany’s top LNG suppliers, Venture Global is proud to strengthen our partnership with EnBW and support the region’s energy security with a reliable supply of LNG,” said Venture Global CEO Mike Sabel. “The new mid-term agreements build on our strong, long-standing relationship with EnBW and reflects our commitment to meeting our customers’ evolving energy needs. Our dynamic marketing platform uniquely positions us to provide supply solutions across the short, medium, and long term.” About Venture Global Venture Globa
Kinaxis Announces Results of Voting at Annual and Special Meeting of Shareholders17.6.2026 22:05:00 CEST | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, received approval for all resolutions put forward to shareholders at today’s Annual and Special Meeting of Shareholders (the “Meeting”), as detailed in the Company’s management information circular dated May 5, 2026 (the “Circular”). 1. Election of Directors Shareholders voted to elect all eight directors nominated to the Kinaxis board, to hold office until the close of the next annual meeting of shareholders of the Company or until their successors are elected or appointed. Name of Nominee Total Number of Votes For Percentage of Votes For Total Number of Votes Against Percentage of Votes Against Razat Gaurav 21,870,163 99.01% 219,468 0.99% Robert Courteau 20,882,945 94.54% 1,206,685 5.46% Gillian (Jill) Denham 21,474,486 97.22% 615,143 2.78% José Alberto Duarte 21,699,181 98.23% 390,448 1.77% Lynn Loewen 21,952,244 99.38% 137,387 0.62% Angel Mendez 21,410,402 96
SES Announces Results of the Extraordinary General Meeting of Shareholders17.6.2026 19:23:00 CEST | Press release
SES (the “Company”) held an Extraordinary General Meeting (“EGM”) of Shareholders today in Betzdorf, Luxembourg. Following the recommendations made by the Board of Directors of SES, the shareholders have voted in favor of all resolutions. In particular, shareholders approved the cancellation of shares repurchased under the Company’s share buyback program of 2 November 2023, as amended on 2 May 2024, resulting in a corresponding reduction of the Company’s share capital. Shareholders also approved amendments to the Company’s articles of association, including indemnification for Board members and executives, as well as updates relating to the conduct of shareholder meetings. Detailed results on all matters voted on at the EGM will be available on the company’s webpage: https://www.ses.com/company/investors/shareholder-information/general-meeting-shareholders Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES At SES, we b
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