Intercept Announces Publication of Results from the Interim Analysis of the Phase 3 REGENERATE Study of OCA for the Treatment of Fibrosis Due to NASH in The Lancet

Posted in Biotech

December 06, 2019 • 2 min read

​Intercept Pharmaceuticals, Inc. (Nasdaq:ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat progressive non-viral liver diseases, today announced that the positive results from the interim analysis of the Phase 3 REGENERATE study of obeticholic acid (OCA) in patients with fibrosis due to nonalcoholic steatohepatitis (NASH)...

Aurinia Announces Positive AURORA Phase 3 Trial Results Demonstrating Voclosporin Superiority Over Standard of Care in Lupus Nephritis

Posted in Biotech

December 05, 2019 • 2 min read

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (“Aurinia” or the “Company”), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple inflammatory and autoimmune conditions, today announced positive efficacy and safety results from its pivotal AURORA Phase 3 trial of voclosporin, in combination with mycophenolate...

Sage Therapeutics Reports Topline Results from Pivotal Phase 3 MOUNTAIN Study of SAGE-217 in Major Depressive Disorder

Posted in Biotech

December 05, 2019 • 4 min read

Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo...

GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on EPIDIOLEX (cannabidiol) Oral Solution at the American Epilepsy Society Annual Meeting

Posted in Biotech

December 05, 2019 • 2 min read

​GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, along with U.S. subsidiary Greenwich Biosciences announced today that a variety of data, including results from completed Phase 3 trials of EPIDIOLEX (cannabidiol) oral solution CV, will be presented at the American Epilepsy Society (AES) Annual Meeting, December 6-10, in Baltimore...

Cytokinetics Announces New Results Presented at the International Symposium on ALS/MND

Posted in Biotech

December 05, 2019 • 2 min read

​Cytokinetics (Nasdaq: CYTK) today announced that new results were presented at the 30th International Symposium on ALS/MND in Perth, Australia, including additional analyses from FORTITUDE-ALS (Functional Outcomes in a Randomized Trial of Investigational Treatment with CK-2127107 to Understand Decline in Endpoints – in ALS), the Phase 2 clinical trial of reldesemtiv in patients with amyotrophic lateral sclerosis (ALS)...

Predictive Oncology Confirms Indications of Interest for Skyline Medical Business

Posted in Biotech

December 05, 2019 • 2 min read

​MINNEAPOLIS, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Predictive Oncology Inc. (NASDAQ: POAI), focused on applying artificial intelligence (“AI”) to personalized medicine and drug discovery, today announced that it has received indications of interest from several parties for the possible acquisition of its Skyline Medical division, which produces and sells the STREAMWAY System...

Astellas Enters into Definitive Agreement to Acquire Audentes Therapeutics

Posted in Biotech

December 03, 2019 • 2 min read

​Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Audentes Therapeutics, Inc. (NASDAQ: BOLD, Chairman and CEO: Matthew R. Patterson, “Audentes”), today announced that they have entered into a definitive agreement for Astellas to acquire Audentes...

Cara Therapeutics Announces Positive Topline Data From Phase 2 Trial of Oral KORSUVA in Chronic Kidney Disease Patients with Moderate-to-Severe Pruritus

Posted in Biotech

December 03, 2019 • 2 min read

Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVA (CR845/difelikefalin) for the treatment of pruritus...

Lexicon Pharmaceuticals Completes Safety Review of Initial Safety Run-in Cohort of TELE-ABC Study, a Phase 2 Clinical Study of Telotristat Ethyl in Biliary Tract Cancer

Posted in Biotech

December 03, 2019 • 2 min read

Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), announced today the completion of a safety review of the initial run-in cohort of the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, which is a Phase 2 clinical study of telotristat ethyl in patients with biliary tract cancer. Telotristat ethyl...