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
KATE Launches "KABUKE: Break Convention" Kabuki-Inspired International Campaign17.7.2026 09:00:00 CEST | Press release
Where “NO MORE RULES.” intersects with the Kabuku spirit. Inspired by Japanese aesthetics, KATE shares the value of shadow enhancing makeup and self‑expression with the world. Global cosmetics brand KATE launched “KABUKE: Break Convention,” a new international campaign drawing on elements of Kabuki, the traditional Japanese performing art. The campaign debuted on Wednesday, July 8, 2026. In this campaign, KATE’s shadow enhancing makeup—rooted in Japanese aesthetics—was paired with the Kabuki spirit inherited from traditional Kabuki theater to communicate the value of individuality and self‑expression through makeup on a global scale. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708829427/en/ KATE international campaign “KABUKE: Break Convention” key visual. Dedicated website: https://www.kate-global.net/my/special/kate_kabuki/ Since its founding, KATE has championed the slogan “NO MORE RULES.,” offering makeup that defi
Meiji Seika Pharma: Results from the Global Phase III Trial (Integral-2) of Nacubactam, a Novel β-Lactamase Inhibitor, Highlighted in The Lancet Microbe’s Coverage of ESCMID Global Congress 202617.7.2026 03:00:00 CEST | Press release
Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Toshiaki Nagasato) today announced that results from the global Phase III trial (Integral-2) of nacubactam (Development Code: OP0595), a novel β-lactamase inhibitor, were highlighted in The Lancet Microbe’s coverage of ESCMID Global Congress 2026 (held in Munich, Germany). As highlighted in The Lancet Microbe’s coverage, the key findings presented by Meiji Seika Pharma at ESCMID Global Congress 2026 are as follows: The Integral-2 study (jRCT2031230076) is a global Phase III clinical trial that enrolled patients with complicated urinary tract infections, acute uncomplicated pyelonephritis, hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia, or complicated intra-abdominal infections caused by carbapenem-resistant Gram-negative bacteria (excluding Acinetobacter species). The study has achieved the prespecified study objectives. For the primary endpoint of overall treatme
Yoshihiro Shimamura Joins the Marché du Film’s “Investors Circle 2026” as an Invited Investor, Backing a New Feature Film17.7.2026 03:00:00 CEST | Press release
Shimamura Yoshihiro Film Production Co., Ltd. (Head office: Osaka, Japan; Representative Director: Yoshihiro Shimamura), a company active in film production and investment, today announced that Representative Director Yoshihiro Shimamura has decided to invest in an international feature film after being invited to the “Investors Circle 2026” — a distinction that reflects his standing as one of the field’s most highly regarded producers and investors. Hosted by the Marché du Film, the business arm of the Festival de Cannes and one of the world’s largest film markets, the Investors Circle is an invitation-only summit that connects a select group of private investors with high-end feature films during early-stage financing. Held in Cannes, France, May 16-17, 2026, it brings internationally acclaimed directors and producers together with investors around a curated slate of projects in development. During the summit, Shimamura attended private pitching sessions and, after individual meeting
Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies17.7.2026 00:00:00 CEST | Press release
On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16 Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16 Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-
Merz Completes Inaugural €450 Million Schuldschein Loan Issuance16.7.2026 23:36:00 CEST | Press release
Debut transaction more than three times oversubscribed The Merz Group has successfully completed its first-ever Schuldschein loan issuance, placing a total volume of €450 million in the debt capital market – a multiple of three relating to the launch volume. The debut transaction was significantly oversubscribed and attracted strong interest from all investor groups. The proceeds were settled and paid out today. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260716926041/en/ Dr. Almuth Steinkühler, Chief Financial Officer Merz Group The transaction comprises both fixed- and floating-rate tranches with maturities of three, five, seven, and ten years. Around 50 German and international investors participated, representing a broad range of institutions, including private banks, German federal state-owned banks, public savings banks, cooperative banks, pension funds and occupational pension institutions. With the successful plac
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