Company History
Founded in 1996 in Sweden as Cortendo AB, our original focus was on regulating cortisol secretion in patients with diabetes.
In the course of reinventing, refocusing, and reinvigorating the company, Strongbridge Biopharma has reached a series of pivotal business and clinical milestones.
Strategic Acquisitions
In December 2016, Strongbridge Biopharma acquired the U.S. rights to KEVEYIS® (dichlorphenamide). This acquisition is part of our commitment to expand our portfolio and help meet the needs of patients with rare diseases that are underdiagnosed and undertreated.
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.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) for Adult Growth Hormone Deficiency
Jan 2018
Acquired Macrilen (macimorelin) from Aeterna Zentaris for the diagnosis of Adult Growth Hormone Deficiency
Jul 2017
Last patient enrolled (LPI) in phase 3 SONICS trial of RECORLEV (levoketoconazole) for endogenous Cushing's syndrome
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, being studied for acromegaly, from Aspireo Pharmaceuticals
Aug 2014
First patient enrolled in phase 3 SONICS trial of RECORLEV (levoketoconazole) in endogenous Cushing's syndrome
Aug 2012
Levoketoconazole received EU orphan drug designation
Mar 2012
Levoketoconazole received US orphan drug designation
Feb 2012
Pivoted RECORLEV (levoketoconazole) focus from diabetes to Cushing's syndrome
Please see KEVEYIS Important Safety Information and Full Prescribing Information. Please see Macrilen Important Safety Information and Full Prescribing Information.
The safety and efficacy of RECORLEV (levoketoconazole) and veldoreotide have not been established.