EDELWEISS

ObsEva Presents Clinical Data on Oral GnRH Antagonist Linzagolix at Multiple Congresses

Retrieved on: 
Wednesday, May 25, 2022
International Society, Catholic higher education, HMB, Gynecological Endocrinology, EDELWEISS, Uterine fibroid, Catholic University of Leuven (1834–1968), Doctor of Philosophy, World Congress, PRIMROSE, NASDAQ, LGX, Constipation, Gonadotropin-releasing hormone, Treatment, DYS, Uterus, MBL, Congress, Yale School of Medicine, Safety, Dysmenorrhea, ABT, Pharmaceutical industry, Birth control, Medical imaging, Endometriosis, Woman, MD

GENEVA, Switzerland May 25, 2022 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for womens health, today announced the presentation of clinical data on linzagolix, an oral GnRH antagonist.

Key Points: 
  • GENEVA, Switzerland May 25, 2022 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies for womens health, today announced the presentation of clinical data on linzagolix, an oral GnRH antagonist.
  • The encouraging data presented at these important medical congresses highlight the differentiated therapeutic potential of linzagolix to better address the individual needs of women with uterine fibroids and endometriosis, said Dr. Brandi Howard, Chief Clinical Officer of ObsEva.
  • These data demonstrate that linzagolix with or without add-back therapy (ABT) significantly reduced heavy menstrual bleeding due to uterine fibroids.
  • Linzagolix is an investigational novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile1,2,3.

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
NASDAQ, Health, New Drug Application, Patient, SIX Swiss Exchange, Quality of life, CEO, Birth certificate, Risk, Pregnancy, SEC, Review, Solution, EDELWEISS, Security (finance), Endometriosis, Uterine fibroid, Clinical trial, GLOBE, Nasdaq, Pain, Osteoporosis, Food and Drug Administration, Woman, Linzagolix, Gynaecology, FDA, Birth, Partnership, PDUFA, Gonadotropin-releasing hormone, Fertility, Private Securities Litigation Reform Act, Coronavirus, Investor, Menopause, Report, Drug development, Urology, U.S. Securities and Exchange Commission, Syneos Health, Pharmaceutical industry, Theramex

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.

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.

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

We remain dedicated to providing flexible treatment options for women and look forward to further development of linzagolix in the endometriosis indication.

Key Points: 
  • We remain dedicated to providing flexible treatment options for women and look forward to further development of linzagolix in the endometriosis indication.
  • 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.

ObsEva Hosts Symposium and Presents Clinical Data on Oral GnRH Antagonist Linzagolix at SEUD Congress 2021

Retrieved on: 
Friday, December 10, 2021
EMA, U.S. Securities and Exchange Commission, Uterine fibroid, Birth certificate, Risk, NDA, Investor, KLH-2109, SEC, Patient, Health, Review, Security (finance), Pain, MBL, SIX Swiss Exchange, Dual-energy X-ray absorptiometry, Woman, DXA, Endometriosis, Safety, Drug development, Quality of life, Coronavirus, Private Securities Litigation Reform Act, Urology, Amenorrhea, Nasdaq, History, ABT, EDELWEISS, BMD, FDA, Report, Estradiol, Gonadotropin-releasing hormone, Pharmaceutical industry

Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile1,2,3.

Key Points: 
  • Linzagolix is a novel, once daily, oral GnRH receptor antagonist with a potentially best-in-class profile1,2,3.
  • Obseva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.
  • The primary efficacy endpoint was reduced MBL at 24 weeks (MBL 80 mL and 50% reduction from baseline).
  • Patients were randomized to receive either an oral once daily dose of linzagolix (50mg, 75mg, 100mg or 200mg) or placebo for up 12 weeks.

ObsEva Announces Third Quarter 2021 Financial Results and Business Update

Retrieved on: 
Thursday, November 4, 2021
Woman, Pregnancy, Fertilisation, SIX Swiss Exchange, JGB, Gonadotropin-releasing hormone, Drug development, European Medicines Agency, New Drug Application, EMA, Security (finance), Patient, Private Securities Litigation Reform Act, NASDAQ, Investor, FDA, NYSE, SEC, Risk, Dysmenorrhea, Uterine fibroid, Income, CHMP, Marketing, Company, EDELWEISS, Nasdaq, CEO, NETA, U.S. Securities and Exchange Commission, Linzagolix, Birth certificate, Endometriosis, Research, OGN, Commercial, ABT, Syneos Health, Treatment, Coronavirus, Hormone, Cryptocurrency, Animal, Pharmaceutical industry, Birth control, Online shopping

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland November 4, 2021 ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today reported financial results for the quarter ended September 30, 2021 and provided a business update.
  • As of September 30, 2021, ObsEva had cash and cash equivalents of $62.9 million, compared with $31.2 million as of December 31, 2020.
  • The third quarter 2021 financial report will be available in the financial reports section of the Companys website.
  • To access the third quarter 2021 financial report directly, please click [ h e re ].

ObsEva Announces Relationship with Syneos Health to Commercialize Linzagolix

Retrieved on: 
Wednesday, October 13, 2021
NASDAQ, Company, Private Securities Litigation Reform Act, CRO, Uterine fibroid, Pain, Endometriosis, Risk, Syneos Health, Nasdaq, Pregnancy, Linzagolix, SIX Swiss Exchange, Investor, Gonadotropin-releasing hormone, Drug development, API, SEC, FDA, JGB, U.S. Securities and Exchange Commission, EMA, Birth certificate, Form 6-K, CCO, Woman, Security (finance), EDELWEISS, CEO, Coronavirus, Clinical trial, Patient, Contract research organization, Pharmaceutical industry, Fine chemical

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland, October 13, 2021 ObsEva SA (NASDAQ: OBSV; SIX: OBSN), a biopharmaceutical company dedicated to improving womens reproductive health today announced a strategic relationship with Syneos Health (Nasdaq:SYHN), the only fully integrated biopharmaceutical solutions organization, to commercialize linzagolix.
  • Brian OCallaghan, CEO of ObsEva, commented, We are thrilled to work with Syneos Health on the commercialization of linzagolix.
  • With a leading womens health sales force, Syneos Health is uniquely suited to support our goal of offering relief to women suffering from uterine fibroids.
  • This Syneos Health relationship, together with the newly announced financing facility and revised Kissei license terms, provides ObsEva with a strong foundation to execute on its commercialization plans.

ObsEva Announces Second Quarter 2021 Financial Results and Business Update

Retrieved on: 
Thursday, August 5, 2021
Company, Investor, Chief executive officer, Woman, Gonadotropin-releasing hormone, Hormone, U.S. Securities and Exchange Commission, Endometriosis, Dysmenorrhea, European Medicines Agency, Coronavirus, Fertilisation, Birth certificate, Private Securities Litigation Reform Act, Partnership, Neta, Patient, Abt, CHMP, SIX Swiss Exchange, OGN, EMA, SEC, Uterine fibroid, EDELWEISS, Food and Drug Administration, Risk, Pregnancy, New York Stock Exchange, Treatment, Nasdaq, NDA, Research, Drug development, Marketing, Security (finance), Medical device, Cryptocurrency, Pharmaceutical industry, Birth control, Payment card

53 LR of the SIX Swiss Exchange

Key Points: 
  • 53 LR of the SIX Swiss Exchange
    GENEVA, Switzerland August 5, 2021 ObsEva SA (NASDAQ: OBSV) (SIX: OBSN), a biopharmaceutical company developing and commercializing novel therapies to improve womens reproductive health, today reported financial results for the quarter ended June 30, 2021 and provided a business update.
  • As of June 30, 2021, ObsEva had cash and cash equivalents of $58.9 million, compared with $31.2 million as of December 31, 2020.
  • The second quarter 2021 financial report will be available in the financial reports section of the Companys website.
  • To access the second quarter 2021 financial report directly, please click [ here ].