Company History Key Milestones Recent business and clinical milestones reflect our focus on rare diseases and our organizational agility in meeting the challenges of drug development and commercialization. In the course of reinventing, refocusing, and reinvigorating the company, Strongbridge Biopharma has reached a series of pivotal business and clinical milestones. May 2021 Xeris Pharmaceuticals, Inc. to acquire Strongbridge Biopharma plc in stock and CVR transaction Mar 2021 Submission of new drug application (NDA) for levoketoconazole to the U.S. Food & Drug Administration Sep 2020 Reported positive top-line results from the pivotal phase 3 LOGICS study of levoketoconazole for the treatment of endogenous Cushing’s syndrome Sep 2019 Announced levoketoconazole phase 3 SONICS data published in The Lancet Diabetes & Endocrinology Dec 2018 Announced closing of transaction with Novo Nordisk to transfer rights to Macrilen™ (macimorelin) in the United States and Canada Aug 2018 Reported positive top-line results from the pivotal phase 3 SONICS study of levoketoconazole for the treatment of endogenous Cushing’s syndrome Jul 2018 Launched Macrilen™ (macimorelin) Jan 2018 Acquired Macrilen™ (macimorelin) from Aeterna Zentaris, added to rare endocrine franchise Apr 2017 Launched KEVEYIS® (dichlorphenamide) for Primary Periodic Paralysis Dec 2016 Acquired KEVEYIS® (dichlorphenamide) from Taro Pharmaceutical Industries for Primary Periodic Paralysis Jun 2015 Acquired veldoreotide from Aspireo Pharmaceuticals Aug 2012 Levoketoconazole received EU orphan drug designation Mar 2012 Levoketoconazole received US orphan drug designation Feb 2012 Pivoted levoketoconazole focus from diabetes to Cushing's syndrome Oct 1996 Strongbridge Biopharma founded with focus on cortisol secretion (originally Cortendo AB) Please see KEVEYIS Important Safety Information and Full Prescribing Information. The safety and efficacy of levoketoconazole and veldoreotide have not been established. View our Board of Directors PRIVACY POLICY TERMS OF USE CONTACT US CAREERS For accessibility-related questions, comments, or concerns about this digital property, please email info@strongbridgebio.com and we will reply to your message. © 2021 Strongbridge Biopharma plc STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Dublin Limited and Strongbridge U.S. Inc. KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc. MLR-0010 V21 06/2021 Ireland Address: Suite 206, Fitzwilliam Hall Fitzwilliam Place, Dublin 2, D02 T292 Ireland U.S. Address: 900 Northbrook Drive, Suite 200 Trevose, PA 19053 United States Phone: +1 610-254-9200 info@strongbridgebio.com Privacy Statement Compliance Program × This website intends to use cookies to improve the site and your experience. By continuing to browse this website, you are agreeing to accept our use of cookies. To learn more about our Privacy Statement, click here.