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.