Triketones

Allena Pharmaceuticals Provides Update on Clinical Development Programs

Retrieved on: 
Monday, July 12, 2021
Nitrogen cycle, Triketones, Uric acid, Branches of biology, Inborn errors of purine-pyrimidine metabolism, Kidney, Organ systems, Anatomy, Acute uric acid nephropathy, Hyperuricemia

Evaluation of clinical and laboratory parameters revealed no significant safety signals and no serious adverse events were reported.

Key Points: 
  • Evaluation of clinical and laboratory parameters revealed no significant safety signals and no serious adverse events were reported.
  • Key bioactivity endpoints will include serum uric acid level, 24-hour urine uric acid level, and renal clearance of uric acid.
  • Allena Pharmaceuticals, Inc.is a biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class, oral biologic therapeutics to treat patients with rare and severe metabolic and kidney disorders.
  • All information in this press release is as of the date of the release, and Allena undertakes no duty to update this information unless required by law.

ObsEva Announces Final Results from the Phase 3 PRIMROSE Program of Yselty® (linzagolix) for the Treatment of Uterine Fibroids

Retrieved on: 
Thursday, May 20, 2021
Organ systems, Endocrine system, Hormones, GnRH antagonists, Ethers, Triketones, Antiandrogens, Antiestrogens, Uterine fibroid, Gonadotropin-releasing hormone antagonist, Heavy menstrual bleeding, Linzagolix

These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and US) studies.\nThe PRIMROSE 1 and PRIMROSE 2 trials evaluated 100 mg and 200 mg doses with and without ABT.

Key Points: 
  • These results mark the final data measuring point for both the Phase 3 PRIMROSE 1 (US only) and PRIMROSE 2 (Europe and US) studies.\nThe PRIMROSE 1 and PRIMROSE 2 trials evaluated 100 mg and 200 mg doses with and without ABT.
  • Improvements in other clinically relevant secondary endpoints, including hemoglobin levels and quality of life also persisted off-treatment, supporting the durability of the treatment effect of Yselty.
  • \xe2\x80\x9cThis milestone represents the next critical step in bringing Yselty forward as a well-differentiated, once daily oral GnRH antagonist with unique dosing options designed to treat more women with uterine fibroids.
  • Linzagolix is currently in late-stage clinical development for the treatment of heavy menstrual bleeding associated with uterine fibroids and pain associated with endometriosis.

ObsEva SA presents posters at the ACOG Annual Clinical and Scientific Virtual Meeting April 30 - May 2, 2021

Retrieved on: 
Friday, April 30, 2021
Medicine, Clinical medicine, Medical specialties, Gynaecological neoplasia, Uterine fibroid, Ethers, GnRH antagonists, Triketones, Linzagolix, Hysterectomy, Kissei, Preterm birth

Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses.

Key Points: 
  • Uterine fibroids affect women of childbearing age and can vary in size from undetectable to large bulky masses.
  • Few long-term medical treatments are available, and as a result, approximately 300,000 hysterectomies are performed for uterine fibroids every year in the US.
  • Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids and preterm labor.
  • ObsEva licensed linzagolix from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for the product.

VYNE Therapeutics to Report First Quarter 2021 Financial Results on May 6, 2021

Retrieved on: 
Wednesday, April 28, 2021
Hepatotoxins, Anti-acne preparations, Tetracycline antibiotics, Minocycline, Triketones, XC2, Medication package insert, Drugs, Health sciences, Health

b'A replay of the call will be archived on the Company\xe2\x80\x99s website at www.vynetherapeutics.com after the conference call.\nVYNE\xe2\x80\x99s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.\nWith expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST\xe2\x84\xa2), and has received FDA approval for AMZEEQ\xc2\xae (minocycline) topical foam, 4%, the world\xe2\x80\x99s first topical minocycline, and for ZILXI\xc2\xae (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.\xc2\xa0For more information about our approved products, please see AMZEEQ\xe2\x80\x99s Full Prescribing Information at AMZEEQ.com and ZILXI\xe2\x80\x99s Full Prescribing Information at ZILXI.com .\nFor more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter.

Key Points: 
  • b'A replay of the call will be archived on the Company\xe2\x80\x99s website at www.vynetherapeutics.com after the conference call.\nVYNE\xe2\x80\x99s mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.\nWith expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST\xe2\x84\xa2), and has received FDA approval for AMZEEQ\xc2\xae (minocycline) topical foam, 4%, the world\xe2\x80\x99s first topical minocycline, and for ZILXI\xc2\xae (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea.\xc2\xa0For more information about our approved products, please see AMZEEQ\xe2\x80\x99s Full Prescribing Information at AMZEEQ.com and ZILXI\xe2\x80\x99s Full Prescribing Information at ZILXI.com .\nFor more information about VYNE Therapeutics Inc. or its investigational products, visit www.vynetherapeutics.com or follow VYNE on Twitter.
  • VYNE may use its website to comply with its disclosure obligations under Regulation FD.
  • Therefore, investors should monitor VYNE\xe2\x80\x99s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.\n'

Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization Application for Relugolix for the Treatment of Advanced Prostate Cancer

Retrieved on: 
Monday, March 29, 2021
Chemical compounds, Chemistry, Organic compounds, Ethers, GnRH antagonists, Triketones, Prodrugs, Testosterone, Relugolix, Prostate cancer, Androgen deprivation therapy, Conjugated estrogens

The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process.

Key Points: 
  • The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process.
  • We are delighted that the Marketing Authorization Application for relugolix has been accepted for review by the European Medicines Agency.
  • This is an important milestone in bringing a potential oral treatment option to men with advanced prostate cancer in Europe, said David Marek, Chief Executive Officer of Myovant Sciences, Inc.
  • Following our recent FDA approval and launch in the U.S., we believe relugolix has the potential to transform the standard of care for men with advanced prostate cancer requiring androgen deprivation therapy.

Myovant Sciences and Pfizer Announce Positive Data from Phase 3 LIBERTY Randomized Withdrawal Study of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Retrieved on: 
Wednesday, March 24, 2021
Chemical compounds, Organic compounds, GnRH antagonists, Chemistry, Ethers, Triketones, Gynaecological neoplasia, Uterine fibroid, Relugolix, Heavy menstrual bleeding, Placebo-controlled study

Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.

Key Points: 
  • Data from the LIBERTY randomized withdrawal study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.
  • The LIBERTY randomized withdrawal study (N = 229) was a Phase 3 double-blind, placebo-controlled study that enrolled eligible women who completed the LIBERTY long-term extension study.
  • Women on placebo with relapse of heavy menstrual bleeding during the study were offered re-treatment with open-label relugolix combination therapy.
  • We believe that these study results offer encouraging data in support of longer-term efficacy in women suffering from uterine fibroids.

Sumitovant Biopharma’s Portfolio of Innovative Companies Achieve Significant Clinical and Corporate Milestones in its Third Quarter of Operation

Retrieved on: 
Tuesday, March 2, 2021
Chemical compounds, Organic compounds, Chemistry, Ethers, Pyrimidines, Relugolix, Triketones, Ureas, Roivant Sciences, Prostate cancer

today announced that its five subsidiary healthcare companies ( Myovant , Urovant , Enzyvant , Altavant and Spirovant ) achieved multiple clinical and corporate milestones in the companys third quarter ending on December 31, 2020.

Key Points: 
  • today announced that its five subsidiary healthcare companies ( Myovant , Urovant , Enzyvant , Altavant and Spirovant ) achieved multiple clinical and corporate milestones in the companys third quarter ending on December 31, 2020.
  • We are pleased to see so much progress in Sumitovants third quarter of operation.
  • On December 18, 2020, the FDA approved Myovants ORGOVYXTM (relugolix) for the treatment of adult patients with advanced prostate cancer.
  • Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

Sumitovant Biopharma Announces Publication in the New England Journal of Medicine of Myovant Sciences Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Retrieved on: 
Thursday, February 18, 2021
Chemical compounds, Drugs, Organic compounds, GnRH antagonists, Ethers, Triketones, Pyrimidines, Relugolix, Ureas, Menstruation, Uterine fibroid, Medroxyprogesterone acetate

Peer-reviewed publication of these two important studies in the New England Journal of Medicine is a significant step forward for women who suffer from uterine fibroids, said Myrtle Potter, chief executive officer of Sumitovant Biopharma.

Key Points: 
  • Peer-reviewed publication of these two important studies in the New England Journal of Medicine is a significant step forward for women who suffer from uterine fibroids, said Myrtle Potter, chief executive officer of Sumitovant Biopharma.
  • On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline in each study (both p
  • Data showed changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment in LIBERTY 1 and LIBERTY 2.
  • Sumitovant is the majority shareholder of Myovant Sciences and Urovant Sciences, and wholly owns Enzyvant Therapeutics, Spirovant Sciences, and Altavant Sciences.

Myovant Sciences and Pfizer Announce Publication in the New England Journal of Medicine of Phase 3 LIBERTY Studies of Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Retrieved on: 
Wednesday, February 17, 2021
Chemical compounds, Organic compounds, Drugs, GnRH antagonists, Ethers, Triketones, Ureas, Pyrimidines, Relugolix, Menstruation, Uterine fibroid, Medroxyprogesterone acetate

In the LIBERTY studies, relugolix combination therapy improved the most bothersome symptoms of uterine fibroids and had a well-tolerated safety profile including maintenance of bone mineral density comparable to placebo.

Key Points: 
  • In the LIBERTY studies, relugolix combination therapy improved the most bothersome symptoms of uterine fibroids and had a well-tolerated safety profile including maintenance of bone mineral density comparable to placebo.
  • The data published in the New England Journal of Medicine underscore the potential of relugolix combination therapy to provide an important new treatment option for this common disease.
  • On average, women receiving relugolix combination therapy experienced an 84.3% reduction in menstrual blood loss from baseline in each study (both p
  • Data showed changes in bone mineral density were comparable between the relugolix combination and placebo groups at the end of treatment in LIBERTY 1 and LIBERTY 2.

Myovant Sciences to Host Third Fiscal Quarter 2020 Earnings Conference Call at 8:30 a.m. Eastern Time on February 11, 2021

Retrieved on: 
Friday, January 29, 2021
Chemical compounds, Organic compounds, Chemistry, GnRH antagonists, Ethers, Pyrimidines, Relugolix, Triketones, Ureas, Prostate cancer, Food and Drug Administration

The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on February 11, 2021.

Key Points: 
  • The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on February 11, 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 .
  • Myovant Sciencesaspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy.
  • We have one FDA-approved medicine, ORGOVYX (relugolix), for adult patients with advanced prostate cancer.