Latest News and Press Releases

~ Study Confirms Long-Term Treatment with KEVEYIS is Safe and Effective for Chronic Use ~ ~ Analyses Provide Potentially Useful Information to Help Guide Clinician Patient Counseling & Management...

DUBLIN, Ireland and TREVOSE, Pa., June 03, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and...

~ FDA Sets Prescription Drug User Fee Act (PDUFA) Target Action Date of January 1, 2022 ~ ~ If Approved, RECORLEV® (levoketoconazole) Launch Planned for First Quarter of 2022 ~ DUBLIN, Ireland...

~ Reports KEVEYIS® (dichlorphenamide) First Quarter 2021 Revenue of $8.4 Million, a 25 Percent Increase Compared to $6.7 Million of Revenue During First Quarter of 2020 ~ ~ Reiterates Full-Year 2021...

DUBLIN, Ireland and TREVOSE, Pa., May 06, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and...

RECORLEV® (levoketoconazole) Treatment Demonstrates Clinically Meaningful Improvements in Cortisol Control and Clinical Benefit in Patients with Cushing’s Syndrome and Comorbid Diabetes Mellitus ...

~ As Previously Reported, LOGICS Met its Primary Endpoint with Statistical Significance ~ ~ Strongbridge Recently Submitted a New Drug Application (NDA) for RECORLEV® (levoketoconazole) to the U.S....

DUBLIN, Ireland and TREVOSE, Pa., March 15, 2021 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and...

~ Submitted New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome to U.S. Food & Drug Administration ~ ~ KEVEYIS® (dichlorphenamide)...

~ RECORLEV® (levoketoconazole) New Drug Application is Supported by Previously-Reported Positive and Statistically Significant Results from the Phase 3 SONICS and LOGICS Studies ~ ~ Nearly 40 Percent...