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Strongbridge Biopharma plc (SBBP.OQ)

SBBP.OQ on NASDAQ Stock Exchange Global Select Market

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24 May 2019
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Latest Key Developments (Source: Significant Developments)

Strongbridge Biopharma Reports Top-Line Results from Extended Phase 3 Study of RECORLEV for Treatment of Endogenous Cushing's Syndrome
Monday, 11 Mar 2019 

March 11 (Reuters) - Strongbridge Biopharma plc ::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 CUSHING’S SYNDROME.STRONGBRIDGE BIOPHARMA - EXTENDED EVALUATION PHASE MEETS OBJECTIVE OF SHOWING POSITIVE LONG-TERM BENEFIT-RISK PROFILE OF RECORLEV (LEVOKETOCONAZOLE).STRONGBRIDGE BIOPHARMA PLC - LONG-TERM EFFICACY RESULTS OF RECORLEV™ (LEVOKETOCONAZOLE) CONTINUE TO DEMONSTRATE CLINICALLY MEANINGFUL IMPROVEMENTS.STRONGBRIDGE BIOPHARMA - NO PATIENTS EXPERIENCED INCREASE IN ALT OR AST OF GREATER THAN 3 TIMES UPPER LIMIT OF NORMAL IN EXTENDED EVALUATION PHASE.STRONGBRIDGE BIOPHARMA - RECORLEV GENERALLY WELL-TOLERATED DURING EXTENDED EVALUATION PHASE AND NO NEW DRUG-RELATED SAFETY SIGNALS WERE OBSERVED.  Full Article

Strongbridge Biopharma Q4 Non-GAAP Loss Per Share $0.46
Tuesday, 26 Feb 2019 

Feb 26 (Reuters) - Strongbridge Biopharma plc ::REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL RESULTS.Q4 NON-GAAP LOSS PER SHARE $0.46.Q4 GAAP EARNINGS PER SHARE $1.73.Q4 EARNINGS PER SHARE ESTIMATE $-0.49 -- REFINITIV IBES DATA.SEES FY 2019 REVENUE $18 MILLION TO $20 MILLION.COMPANY ANTICIPATES POSITIVE KEVEYIS CONTRIBUTION MARGIN BY END OF Q1 OF 2020.QTRLY TOTAL REVENUES $4.5 MILLION VERSUS ABOUT $3 MILLION.  Full Article

Strongbridge Biopharma Reports Q4 Non-Gaap Loss $0.46 Per Share
Tuesday, 26 Feb 2019 

Feb 26 (Reuters) - Strongbridge Biopharma plc ::SEES FY 2019 KEVEYIS(DICHLORPHENAMIDE)REVENUE $18 MILLION TO $20 MILLION.REPORTS FOURTH QUARTER AND FULL-YEAR 2018 FINANCIAL RESULTS.Q4 NON-GAAP LOSS PER SHARE $0.46.Q4 GAAP EARNINGS PER SHARE $1.73.Q4 EARNINGS PER SHARE ESTIMATE $-0.49 -- REFINITIV IBES DATA.COMPANY ANTICIPATES POSITIVE KEVEYIS CONTRIBUTION MARGIN BY END OF Q1 OF 2020.QTRLY TOTAL REVENUES $4.5 MILLION VERSUS ABOUT $3 MILLION.  Full Article

Strongbridge Biopharma - Entered A Payoff Letter With CRG Servicing
Wednesday, 19 Dec 2018 

Dec 19 (Reuters) - Strongbridge Biopharma plc ::STRONGBRIDGE BIOPHARMA - ENTERED INTO A PAYOFF LETTER WITH CRG SERVICING, CO AGREED TO PAY OFF, TERMINATE TERM LOAN AGREEMENT, DATED JULY 14, 2017.STRONGBRIDGE BIOPHARMA PLC - ON DEC 18, EXERCISED PUT OPTION IN ACCORDANCE WITH MACRILEN ACQUISITION AGREEMENT.STRONGBRIDGE BIOPHARMA PLC - COMPANY WILL ISSUE AN AGGREGATE OF 656,929 ORDINARY SHARES OF COMPANY WITH AN APPROXIMATE AGGREGATE VALUE OF $3 MILLION.STRONGBRIDGE BIOPHARMA PLC - PURSUANT TO TERMS OF PAYOFF LETTER, SBUS WILL PAY, ON OR ABOUT DECEMBER 18, A TOTAL OF $100.3 MILLION TO LENDERS.  Full Article

Strongbridge Biopharma PLC Presents Detailed Initial Results
Monday, 22 Oct 2018 

Oct 22 (Reuters) - Strongbridge Biopharma plc ::STRONGBRIDGE BIOPHARMA PLC PRESENTS DETAILED INITIAL RESULTS FROM PIVOTAL PHASE 3 SONICS STUDY OF RECORLEV™ (LEVOKETOCONAZOLE) FOR THE TREATMENT OF ENDOGENOUS CUSHING’S SYNDROME AT THE 18TH ANNUAL CONGRESS OF THE EUROPEAN NEUROENDOCRINE ASSOCIATION.STRONGBRIDGE BIOPHARMA PLC - RECORLEV MONOTHERAPY NORMALIZED UFC INITIALLY IN 81 PERCENT OF PATIENTS WHO ADVANCED INTO MAINTENANCE PHASE.STRONGBRIDGE BIOPHARMA PLC - SONICS STUDY MET ITS PRIMARY ENDPOINT.STRONGBRIDGE BIOPHARMA PLC - SONICS STUDY ACHIEVING STATISTICAL SIGNIFICANCE OF SECONDARY ENDPOINTS.  Full Article

Strongbridge Biopharma Files For Mixed Shelf Of Up To $91.2 Mln
Monday, 12 Mar 2018 

March 12 (Reuters) - Strongbridge Biopharma Plc ::STRONGBRIDGE BIOPHARMA PLC FILES FOR MIXED SHELF OF UP TO $91.2 MILLION - SEC FILING.  Full Article

Strongbridge Announces Acquisition Of U.S., Canadian Rights To Macrilen From Aeterna Zentaris
Wednesday, 17 Jan 2018 

Jan 17 (Reuters) - Strongbridge Biopharma Plc ::STRONGBRIDGE BIOPHARMA PLC ANNOUNCES ACQUISITION OF THE U.S. AND CANADIAN RIGHTS TO MACRILEN™ (MACIMORELIN) FROM AETERNA ZENTARIS.STRONGBRIDGE BIOPHARMA - ‍UNDER TERMS OF AGREEMENT, CO TO MAKE UPFRONT PAYMENT OF $24 MILLION TO AETERNA WITHIN 5 DAYS OF EFFECTIVE DATE OF AGREEMENT​.STRONGBRIDGE BIOPHARMA - LICENSE & ASSIGNMENT AGREEMENT ALSO PROVIDES CO WITH EXCLUSIVE LICENSE TO MANUFACTURE & COMMERCIALIZE MACRILEN IN U.S. & CANADA.STRONGBRIDGE BIOPHARMA PLC - STRONGBRIDGE EXPECTS TO COMMERCIALLY LAUNCH MACRILEN IN MID-YEAR 2018.STRONGBRIDGE BIOPHARMA PLC - ‍EXPANDS STRUCTURED FINANCING FACILITY WITH CRG TO SUPPORT ANTICIPATED COMMERCIAL LAUNCH OF MACRILEN IN MID-2018​.STRONGBRIDGE BIOPHARMA - AETERNA ZENTARIS WILL REMAIN RESPONSIBLE FOR A PEDIATRIC DEVELOPMENT PROGRAM TO SUPPORT REGULATORY SUBMISSION FOR MACRILEN APPROVAL.STRONGBRIDGE - ‍IN CONJUNCTION WITH MACRILEN DEAL, CO, CRG AMENDED EXISTING SENIOR CREDIT FACILITY TO INCREASE TOTAL POTENTIAL BORROWING TO $100 MILLION​.STRONGBRIDGE BIOPHARMA-CO SHARING OVERSIGHT AND PAYING FOR 70 PERCENT OF COST OF PEDIATRIC DEVELOPMENT PROGRAM OR ABOUT $4 MILLION OVER A 3-YEAR PERIOD​.STRONGBRIDGE - ‍UNDER AMENDED FACILITY, CO RETAINED OPTION TO BORROW ADDITIONAL $10 MILLION BASED UPON SOME CONDITIONS​.STRONGBRIDGE - ‍INTENDS TO USE UPFRONT PROCEEDS FROM SECOND BORROWING TO FUND ACQUISITON, COMMERCIALIZATION OF MACRILEN, CORPORATE PURPOSES​.  Full Article

Strongbridge Gets Letters From Offices Of U.S. Senators Requesting Information On Marketing & Sales Of Keveyis
Thursday, 21 Dec 2017 

Dec 21 (Reuters) - Strongbridge Biopharma Plc ::STRONGBRIDGE BIOPHARMA - ON DEC 19, RECEIVED LETTERS FROM OFFICES OF U.S. SENATORS THAT REQUEST INFORMATION RELATING TO MARKETING & SALES OF KEVEYIS.STRONGBRIDGE BIOPHARMA - LETTERS REQUEST INFORMATION PRINCIPALLY RELATING TO THE PRICING OF KEVEYIS, AMONG OTHER THINGS - SEC FILING.STRONGBRIDGE BIOPHARMA - CO IN THE PROCESS OF RESPONDING TO THE LETTERS.  Full Article

Strongbridge Biopharma Q3 loss per share $0.98
Tuesday, 14 Nov 2017 

Nov 14 (Reuters) - Strongbridge Biopharma Plc :Strongbridge Biopharma Plc provides corporate update and reports third quarter 2017 financial results.Q3 non-GAAP loss per share $0.35.Q3 GAAP loss per share $0.98.Q3 earnings per share view $-0.38 -- Thomson Reuters I/B/E/S.Strongbridge Biopharma Plc- ‍Recorlev (levoketoconazole) phase 3 top-line results remain on track with SONICS in Q2 2018 and LOGICS in Q4 2018​.Strongbridge Biopharma Plc- existing cash resources at Sept 30, net proceeds from Oct offering provides sufficient cash under current operating plan​.Strongbridge Biopharma Plc- ‍had pro forma cash and cash equivalents of $67.8 million as of September 30, 2017​.Strongbridge Biopharma Plc - qtrly total revenues $‍2.5 million​.  Full Article