In the course of reinventing, refocusing, and reinvigorating the company, Strongbridge Biopharma has reached a series of pivotal business and clinical milestones.
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.
Reported positive top-line results from the pivotal Phase 3 LOGICS study of levoketoconazole for the treatment of endogenous Cushing’s syndrome
Announced levoketoconazole Phase 3 SONICS data published in The Lancet Diabetes & Endocrinology
Announced closing of transaction with Novo Nordisk to transfer rights to Macrilen™ (macimorelin) in the United States and Canada
Reported positive top-line results from the pivotal Phase 3 SONICS study of levoketoconazole for the treatment of endogenous Cushing’s syndrome
Launched Macrilen (macimorelin) for Adult Growth Hormone Deficiency
Acquired Macrilen (macimorelin) from Aeterna Zentaris for the diagnosis of Adult Growth Hormone Deficiency
Last patient enrolled (LPI) in phase 3 SONICS trial of RECORLEV (levoketoconazole) for endogenous Cushing's syndrome
Launched KEVEYIS (dichlorphenamide) for Primary Periodic Paralysis
Acquired KEVEYIS (dichlorphenamide) from Taro Pharmaceutical Industries for Primary Periodic Paralysis
Acquired veldoreotide, being studied for acromegaly, from Aspireo Pharmaceuticals
First patient enrolled in phase 3 SONICS trial of RECORLEV (levoketoconazole) in endogenous Cushing's syndrome
Levoketoconazole received EU orphan drug designation
Levoketoconazole received US orphan drug designation
Pivoted RECORLEV (levoketoconazole) focus from diabetes to Cushing's syndrome
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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 V18 05/2020