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...

BridgeBio Pharma’s Origin Biosciences Initiates Rolling Submission of New Drug Application with the U.S. FDA for BBP-870 for the Treatment of MoCD Type A

Posted in Biotech

December 03, 2019 • 2 min read

​BridgeBio Pharma, Inc. (Nasdaq: BBIO) subsidiary Origin Biosciences has initiated a rolling submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) for fosdenopterin (BBP-870/ORGN001) for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A....

Outlook Therapeutics Receives FDA Agreement for Three Special Protocol Assessments for Additional Planned Clinical Trials of ONS-5010

Posted in Biotech

December 03, 2019 • 2 min read

​Outlook Therapeutics, Inc. (NASDAQ: OTLK) (the “Company”), a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced that it has received agreement from the U.S. Food and Drug Administration (“FDA”)...