Norethisterone

Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

Retrieved on: 
Saturday, August 6, 2022 - 1:50am
Linda, FDA, Woman, Hospital, Dysmenorrhea, UCSF, Endometriosis, NYSE, Internal medicine, GLOBE, University of California, San Francisco, NEW, Senior, Norethisterone, Roivant Sciences, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pfizer, PFE, Pain, Patient, SPIRIT, Uterine fibroid, Safety, Rusyns, Webcast, Physician, University, Conditional sentence, Chair, Food, Health, Disease, Pharmaceutical industry, Dentistry, Lancet

MYFEMBREE offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.

Key Points: 
  • MYFEMBREE offers an effective, once-daily treatment option for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.
  • MYFEMBREE is available immediately to patients with moderate to severe pain associated with endometriosis with a prescription from their healthcare provider.
  • Myovant and Pfizer also are committed to supporting women in the U.S. who are prescribed MYFEMBREE throughout their treatment journeys.
  • Food and Drug Administration for the management of moderate to severe pain associated with endometriosis, with a treatment duration of up to 24 months.

Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 1 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women With Endometriosis-Associated Pain

Retrieved on: 
Friday, June 17, 2022 - 11:45am
Pfizer, Roivant Sciences, Endometriosis, Dysmenorrhea, Week, GLOBE, Pain, NEW, SPIRIT, Dyspareunia, NYSE, Norethisterone, Woman, PFE, Pharmaceutical industry, Birth control, Medical imaging, Lancet

In both studies, relugolix combination therapy was associated with a generally well-tolerated safety profile, including bone mineral density loss of

Key Points: 
  • In both studies, relugolix combination therapy was associated with a generally well-tolerated safety profile, including bone mineral density loss of
  • Seven key secondary endpoints in SPIRIT 1 and six key secondary endpoints in SPIRIT 2 comparing relugolix combination therapy with placebo at Week 24 also achieved statistical significance.
  • The most frequently reported adverse events in both relugolix combination treatment and placebo groups were headache, nasopharyngitis, and hot flushes.
  • For endometriosis-associated pain, current treatment options include prescription and over-the-counter pain medications, oral contraceptives, GnRH agonists, and antagonists.

Tequity Advised Managed Services Firm Triella on their Acquisition by Miii MSP

Retrieved on: 
Tuesday, April 5, 2022 - 1:41pm
Cloud, 1003, MSP, Software as a service, SME, Norethisterone, Entrepreneurship, School, Software, Technology, Knowledge, Solution, Consultant, Member of the Scottish Parliament, Acquisition, Sales

Triella is a leading managed services provider in Toronto with in-depth knowledge in the legal sector.

Key Points: 
  • Triella is a leading managed services provider in Toronto with in-depth knowledge in the legal sector.
  • Triella helps its clients to maintain and enhance their underlying technology through consulting, assessments, and managed services and solutions.
  • Miii MSP are long-term growth investors in the MSP market with a mission to become North America's leading network of innovative, interactive, and integrated managed service providers.
  • Pamela Miranda, Co-Founder and Partner at Miii MSP said, "Working with Wilf Rapp and Tequity was an absolute pleasure.

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 - 11:00am
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 - 6:00am
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.

Myovant Sciences Announces Preliminary Financial Results for Third Quarter of Fiscal Year 2021

Retrieved on: 
Monday, January 10, 2022 - 11:55am
Infertility, Pain, Man, LinkedIn, Gonadotropin-releasing hormone, FDA, Health care, Webcast, Roivant Sciences, Total, New Drug Application, European Commission, Female, Pregnancy, Union, Private Securities Litigation Reform Act, Medication, Woman, Norethisterone, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Adoption, SEC, Gedeon Richter, Endometriosis, Patient, Uterine fibroid, Food, Therapy, NYSE, Risk, Twitter, GLOBE, Royal commission, ORGOVYX, Sumitomo Dainippon Pharma, Growth, Testosterone, Marketing, Conference, Adult, Relugolix, Review, Prostate cancer, U.S. Securities and Exchange Commission, Fossil fuel, Pharmaceutical industry, Fine chemical, Audit, Pfizer

Furthermore, this press release includes information regarding Myovant Sciences preliminary financial results for the third fiscal quarter ended December 31, 2021.

Key Points: 
  • Furthermore, this press release includes information regarding Myovant Sciences preliminary financial results for the third fiscal quarter ended December 31, 2021.
  • Myovant Sciences is currently in the process of finalizing its financial results for the third fiscal quarter ended December 31, 2021, and the preliminary financial results presented in this press release are based only on preliminary information available to Myovant Sciences as of January 10, 2022.
  • These preliminary financial results should not be viewed as a substitute for audited consolidated financial statements prepared in accordance with U.S. GAAP, and undue reliance should not be placed on Myovant Sciences preliminary financial results.
  • Myovant Sciences independent registered public accounting firm has not audited or reviewed the preliminary financial results included in this press release or expressed any opinion or other form of assurance on such preliminary financial results.

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 - 12:00pm
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 - 6:00am
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.

Nancy Valente, M.D. Joins Myovant Sciences’ Board of Directors

Retrieved on: 
Monday, November 8, 2021 - 11:00am
Audit committee, Female, Sumitomo Dainippon Pharma, Roche, Food, Oregon Health Plan, Growth, Anosy, COVID-19, Pain, University, Review, Uterine fibroid, Gonadotropin-releasing hormone, Pregnancy, Infertility, Oregon, Woman, GLOBE, New Drug Application, Stanford University, Internal medicine, Patient, FDA, Adult, Roivant Sciences, UCSF, Health care, Private Securities Litigation Reform Act, Oregon Health & Science University, San Francisco, Norethisterone, Endometriosis, Twitter, SEC, Texas Health and Science University, United States, Man, Medication, Risk, Senior, University of California, San Francisco, Board, LinkedIn, Breast cancer, NYSE, Leadership, Drug development, Pharmaceutical industry

as an independent member of the companys Board of Directors.

Key Points: 
  • as an independent member of the companys Board of Directors.
  • In addition to her Board appointment, Dr. Valente will chair the Boards Nominating and Corporate Governance Committee and be a member of the Audit Committee.
  • We are excited to welcome Dr. Valente to our Board, said David Marek, Chief Executive Officer of Myovant Sciences, Inc.
  • I am honored to serve on the Board of Directors of Myovant Sciences, said Dr. Valente.

Myovant Sciences to Host Second Fiscal Quarter 2021 Earnings Conference Call at 8:30 a.m. Eastern Time on October 26, 2021

Retrieved on: 
Tuesday, October 12, 2021 - 1:30pm
Twitter, Uterine fibroid, Man, Pain, Endometriosis, Adult, Norethisterone, Pregnancy, Shanda, Food, Gonadotropin-releasing hormone, GLOBE, LinkedIn, Female, Webcast, Relugolix, FDA, Sumitomo Dainippon Pharma, Review, Infertility, Woman, New Drug Application, NYSE, Patient, Pharmaceutical industry

The webcast and conference call will be held at8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time onOctober 26, 2021.

Key Points: 
  • The webcast and conference call will be held at8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time onOctober 26, 2021.
  • Investors and the general public may access a live webcast of the call by visiting the investor relations page of Myovants website at investors.myovant.com .
  • Institutional investors and analysts may also participate in the conference call by dialing 1-800-532-3746 in theU.S.or+1-470-495-9166 from outside theU.S.
  • A replay of the webcast, along with the earnings press release and presentation materials, will be archived on Myovants investor relations website.