Roche was granted priority review by the FDA for the NDA for risdiplam (RG7916) for the treatment of spinal muscular atrophy (SMA). The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is May 24, 2020. The filing acceptance by the FDA triggers a $15 million milestone payment to PTC Therapeutics, Inc. “The FDA’s acceptance of the NDA is an important step towards making risdiplam available to SMA patients in the U.S.,” said Stuart W. Peltz, Ph.D., chi...