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.