Linzagolix

ObsEva Announces UK MHRA Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Tuesday, June 28, 2022
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Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.

Key Points: 
  • Yselty is the only approved oral GnRH antagonist to offer flexible dosing options, with and without additional hormonal therapy, for women suffering from UF.
  • The MHRA approval follows the granting of marketing authorization by the European Commission earlier in June 2022.
  • For women with UF who cannot or do not want to take hormones, Yselty is the first and only approved oral GnRH antagonist with a non-hormonal dosing option.
  • As the first and only approved GnRH antagonist to offer flexible dosing options with and without additional hormonal therapy, we hope to redefine care for women suffering from uterine fibroids.

Theramex Announces European Commission Marketing Authorization for Yselty® (linzagolix), an Oral GnRH Antagonist, for the Treatment of Symptoms of Uterine Fibroids

Retrieved on: 
Friday, June 17, 2022
Medical Supplies, Health, Consumer, Women, Pharmaceutical, Biotechnology, Solution, Gonadotropin-releasing hormone, Fertility, Uterine fibroid, Nasdaq, CHMP, Menopause, Contraindication, Endometriosis, Urology, Theramex, Central Research Laboratories, Pregnancy, Linzagolix, SIX Swiss Exchange, Kissei, Birth, Committee, Physician, Health, Nephrology Dialysis Transplantation, European Commission, European Directive on Traditional Herbal Medicinal Products, Partnership, Adult, Patient, Life, Committee for Medicinal Products for Human Use, Osteoporosis, ABT, Woman, EC, Pharmaceutical industry, UF, EU

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.

Key Points: 
  • 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.
  • 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.
  • Uterine Fibroids affect 25% of women within reproductive age, many with severe symptoms requiring surgery.

ObsEva Announces Confirmation of Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Monday, April 25, 2022
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The positive CHMP opinion, which was initially adopted on December 16, 2021, was confirmed at the April 2022 CHMP meeting following further review of the linzagolix marketing authorization application.

Key Points: 
  • The positive CHMP opinion, which was initially adopted on December 16, 2021, was confirmed at the April 2022 CHMP meeting following further review of the linzagolix marketing authorization application.
  • European Commission decisions are valid in the European Union Member States, as well as Iceland, Norway, and Liechtenstein.
  • ObsEva has entered into a licensing agreement with Theramex to support the commercialization and market introduction of linzagolix in Europe.
  • Linzagolix has completed clinical trial development for the treatment of uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis.

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Tuesday, March 22, 2022
EAP, Private Securities Litigation Reform Act, Menstrual cycle, Drug development, Nephrology Dialysis Transplantation, Risk, Norethisterone, Dyspareunia, Investor, Analgesic, SIX Swiss Exchange, Ovulation, EDELWEISS, Fertility, Clinical trial, Infertility, Birth certificate, Coronavirus, Uterine fibroid, Constipation, Urology, Pelvic pain, SEC, Pregnancy, Uterus, Research, Woman, Endometrium, Patient, CEO, Gonadotropin-releasing hormone, Pain, Gynaecology, Security (finance), Sexual intercourse, Safety, Defecation, ABT, Estradiol, U.S. Securities and Exchange Commission, Dysmenorrhea, Endometriosis, Nasdaq, Linzagolix, Fatigue, Disease, Pharmaceutical industry, Birth control, Kissei

EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.

Key Points: 
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.
  • Results from the post-treatment follow-up of EDELWEISS 3 are expected in early 3Q2022.
  • Results from the treatment phase of the extension study (EDELWEISS 6) and its post-treatment follow-up phase are expected in early 3Q2022 and 4Q2022, respectively.

ObsEva Announces Additional Efficacy Results for Linzagolix 200 mg with Add-Back Therapy (ABT) and Linzagolix 75 mg without ABT in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Tuesday, March 22, 2022
EAP, Private Securities Litigation Reform Act, Menstrual cycle, Drug development, Nephrology Dialysis Transplantation, Risk, Norethisterone, Dyspareunia, Investor, Analgesic, SIX Swiss Exchange, Ovulation, EDELWEISS, Fertility, Clinical trial, Infertility, Birth certificate, Coronavirus, Uterine fibroid, Constipation, Urology, Pelvic pain, SEC, Pregnancy, Uterus, Research, Woman, Endometrium, Patient, CEO, Gonadotropin-releasing hormone, Pain, Gynaecology, Security (finance), Sexual intercourse, Safety, Defecation, ABT, Estradiol, U.S. Securities and Exchange Commission, Dysmenorrhea, Endometriosis, Nasdaq, Linzagolix, Fatigue, Disease, Pharmaceutical industry, Birth control, Kissei

EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.

Key Points: 
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.
  • Results from the post-treatment follow-up of EDELWEISS 3 are expected in early 3Q2022.
  • Results from the treatment phase of the extension study (EDELWEISS 6) and its post-treatment follow-up phase are expected in early 3Q2022 and 4Q2022, respectively.

ObsEva Enters into Licensing Agreement with Theramex for the Commercialization of Linzagolix

Retrieved on: 
Thursday, February 10, 2022
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GENEVA, Switzerland, Feb. 10, 2022 (GLOBE NEWSWIRE) -- ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for women’s health, today announced a strategic licensing agreement with Theramex, a leading global pharmaceutical company specializing in women’s health, to support the commercialization and market introduction of linzagolix across global markets outside of the U.S., Canada and Asia.

Key Points: 
  • Theramex is a proven global leader in womens health and the ideal partner to maximize the opportunity for linzagolix in key international markets, said Brian OCallaghan, CEO of ObsEva.
  • This Theramex partnership in Europe, together with our relationship with Syneos Health for the commercialization of linzagolix in the U.S., provides ObsEva with a strong foundation to realize the full value of the linzagolix program.
  • This agreement strengthens our portfolio and we look forward to deploying our extensive global commercial infrastructure to unlock linzagolixs potential.
  • Under the terms of the agreement, ObsEva is entitled to receive royalties of a mid-thirties percentage on commercial sales, which includes the cost of goods sold to Theramex.

Theramex Announces Licensing Agreement with ObsEva for the Commercialisation of Linzagolix for the Treatment of Uterine Fibroids

Retrieved on: 
Thursday, February 10, 2022
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Linzagolix is a GnRH receptor antagonist for the treatment of uterine fibroids.

Key Points: 
  • Linzagolix is a GnRH receptor antagonist for the treatment of uterine fibroids.
  • ObsEva is an ideal partner for Theramex given their focus on developing novel treatments to meet unmet medical needs of women suffering from uterine fibroids, endometriosis, and pre-term labour.
  • Uterine Fibroids affect 25% of women within reproductive age, many with severe symptoms requiring surgery.
  • By licensing 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.

ObsEva Provides Update on EU Marketing Authorisation Process for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids

Retrieved on: 
Friday, February 4, 2022
NASDAQ, Private Securities Litigation Reform Act, Pain, Report, European Medicines Agency, Linzagolix, New Drug Application, Investor, PDUFA, Uterine fibroid, Gonadotropin-releasing hormone, U.S. Securities and Exchange Commission, Clinical trial, Birth certificate, Risk, FDA, Patient, Review, Endometriosis, Security (finance), Urology, SEC, Nephrology Dialysis Transplantation, EMA, SIX Swiss Exchange, Coronavirus, Gynaecology, Drug development, Pregnancy, Nasdaq, Pharmaceutical industry, Kissei

ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.

Key Points: 
  • ObsEva is in dialogue with the EMA to understand areas that may require further clarification and is committed to promptly addressing any questions that could arise.
  • Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile1,2,3.
  • Linzagolix has completed clinical trial development for the treatment of uterine fibroids and is currently in late-stage clinical development for the treatment of pain associated with endometriosis.
  • ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.

Global Endometriosis Drug Forecast and Market Analysis Report 2021-2030: Current Therapies Leave Significant Unmet Needs & Pipeline Therapies Present Promise in Closing Treatment Gaps - ResearchAndMarkets.com

Retrieved on: 
Monday, January 31, 2022
Pharmaceutical, Health, Women, Consumer, Awareness, Growth, Diagnosis, Decision-making, Physician, Woman, Internet, Trademark symbol, CAGR, Fertility, Nonsteroidal anti-inflammatory drug, Disease, AbbVie, Biomarker, Health, Gonadotropin-releasing hormone, Opinion, Linzagolix, Ovulation, Pain, Laparoscopy, Drug development, Therapy, Lists of people executed in the United States, Evotec, Pharmaceutical industry, Fine chemical, Medical imaging, Marketing, Bayer, Endometriosis

The "Endometriosis - Global Drug Forecast and Market Analysis to 2030" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Endometriosis - Global Drug Forecast and Market Analysis to 2030" report has been added to ResearchAndMarkets.com's offering.
  • In particular, the publisher expects the US market will contribute the most to the endometriosis market sales, accounting for roughly 68% of global sales in both 2020 ($730.65M) and 2030 ($577.1M).
  • The launch of GnRH antagonists relugolix and linzagolix across the 7MM will be the main drivers of growth during the forecast period.
  • Treatment for endometriosis should improve over the forecast period, but unmet needs remain.

ObsEva Announces Positive Topline Results for Linzagolix 200 mg with Add-Back Therapy in the Phase 3 EDELWEISS 3 Trial in Patients with Moderate-to-Severe Endometriosis-Associated Pain

Retrieved on: 
Thursday, January 6, 2022
ID, EMA, Clinical trial, Endometriosis, Safety, Pelvic pain, Pregnancy, Urology, Uterine fibroid, Estradiol, Endometrium, Menstrual cycle, Sexual intercourse, Birth certificate, Investor, SIX Swiss Exchange, Patient, Uterus, Fertility, Dysmenorrhea, Nephrology Dialysis Transplantation, Gonadotropin-releasing hormone, Analgesic, BMD, Security (finance), Report, Risk, Private Securities Litigation Reform Act, Gynaecology, Central European Time, Disease, CEO, EAP, SEC, Norethisterone, Research, FDA, EDELWEISS, Woman, Infertility, Pain, Defecation, ABT, Dyspareunia, U.S. Securities and Exchange Commission, Drug development, Constipation, Headache, Linzagolix, Fatigue, Nasdaq, Coronavirus, Ovulation, Pharmaceutical industry, Birth control, Kissei

ObsEva will host a conference call and audio webcast with Dr. Hugh Taylor today, January 6 at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to discuss Phase 3 EDELWEISS 3 trial results of linzagolix.

Key Points: 
  • ObsEva will host a conference call and audio webcast with Dr. Hugh Taylor today, January 6 at 8:00 a.m. Eastern Time/2:00 p.m. Central European Time to discuss Phase 3 EDELWEISS 3 trial results of linzagolix.
  • Investors may participate by dialing 1-877-407-9208 for U.S. callers or +1-201-493-6784 for international callers and refer to conference ID 13725902.
  • EDELWEISS 3 (Europe and the U.S.) was a randomized, double-blind, placebo-controlled, Phase 3 trial that analyzed 484 women with moderate-to-severe EAP.
  • The study included a 200 mg once-daily dose in combination with ABT (1 mg estradiol / 0.5 mg norethindrone acetate), and a 75 mg once-daily dose without ABT.