At least nine PDUFA dates on FDA’s September docket

FDA decisions on at least nine applications are due in September, including four new products to treat orphan diseases.

Up first is Rebisufligene etisparvovec, an AAV9 gene therapy to treat Sanfilippo syndrome type A (MPS IIIA) from Ultragenyx Pharmaceuticals Inc. (NASDAQ:RARE). Approval would cap a strong quarter for Ultragenyx, following FDA’s August approval of AAV8 gene therapy Glenglycos pariglasgene brecaparvovec to treat glycogen storage disease type Ia...