Strongbridge Biopharma plc Update on Its New Drug Application for RECORLEV to the U.S. Food and Drug Administration in the First Quarter of 2021; Continues Its Efforts to Pursue Life Cycle Extension

Strongbridge Biopharma plc announced that it is on-track to submit a New Drug Application (NDA) for RECORLEV to the U.S. Food and Drug Administration in the first quarter of 2021; if approved, the launch of RECORLEV is anticipated in the first quarter of 2022, assuming a projected 10-month review cycle. Based upon clinical pharmacology studies that conducted, the Company continues its efforts to pursue life cycle extension opportunities for KEVEYIS through prosecution of the patent estate.