Aug. 19 Quick Takes: At long last, FDA approves Axsome’s antidepressant

Nearly a year after its original PDUFA date, Auvelity (AXS-05) from Axsome Therapeutics Inc. (NASDAQ:AXSM) gained FDA’s approval to treat major depressive disorder in adults. The company attributed the long regulatory delay to discussions about the label of the therapy, which Chairman and CEO Herriot Tabuteau said the company was pleased with the broadness of. That label does carry a boxed warning, however — for suicidal thoughts and behaviors in pediatric and young adult patients; Auvelity, which combines dextromethorphan with bupropion, is not approved for pediatric patients. The news lifted the biotech’s shares by 40% Friday, adding $690 million to its market cap. 

EMA is reviewing the marketing application for pegzilarginase from Aeglea BioTherapeutics Inc. (NASDAQ:AGLE) to treat arginase 1 deficiency. The application was submitted by Immedica Pharma AB, Aeglea’s commercialization partner in Europe and the Middle East. ...