STRONGBRIDGE BIOPHARMA plc (NASDAQ:SBBP) Files An 8-K Other Events
Item 8.01 Other Information
On March11, 2019, Strongbridge Biopharma plc issued a press release announcing top-line results from the extended evaluation phase of its pivotal Phase 3 SONICS study of RECORLEV™ (levoketoconazole) for the potential treatment of endogenous Cushing’s syndrome. A copy of the press release announcing the results is attached as Exhibit99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Strongbridge Biopharma plc Exhibit
EX-99.1 2 a19-6233_1ex99d1.htm EX-99.1 Exhibit 99.1 Strongbridge Biopharma plc Announces Top-Line Results from Extended Evaluation Phase of the Pivotal Phase 3 SONICS Study of RECORLEV (levoketoconazole) for the Potential Treatment of Endogenous Cushings Syndrome ~ Extended Evaluation Phase Meets Objective of Showing Positive Long-Term Benefit-Risk Profile of RECORLEV (levoketoconazole) ~ ~ Favorable Liver-Related Findings: No Patients Experienced an Increase in Either Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) of Greater than Three Times the Upper Limit of Normal During the Extended Evaluation Phase ~ ~ Long-Term Efficacy Results of RECORLEV (levoketoconazole) Continue to Demonstrate Clinically Meaningful Improvements in Mean Urinary Free Cortisol (mUFC) and Key Cardiovascular Risk Markers ~ Dublin,…
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About STRONGBRIDGE BIOPHARMA plc (NASDAQ:SBBP)
Strongbridge Biopharma plc, formerly Cortendo plc, is a development-stage biopharmaceutical company. The Company is engaged in advancing its product candidates through clinical development. The Company is focused on the development, in-licensing, acquisition and eventual commercialization of several complementary products and product candidates within franchises that target rare diseases. Its principal focus is to build its rare endocrine franchise, which includes product candidates for the treatment of endogenous Cushing’s syndrome and acromegaly. Its product candidate, COR-003 (levoketoconazole), is a cortisol synthesis inhibitor, indicated for the treatment of endogenous Cushing’s syndrome. It is conducting SONICS, a pivotal Phase III clinical trial for COR-003. Its product candidate, COR-005 (veldotide), is a multi-receptor targeted somatostatin analog (SSA) in Phase II clinical development for the treatment of acromegaly patients. Its product candidate also includes BP-2002.