Strongbridge Biopharma plc

78 articles about Strongbridge Biopharma plc

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  FDA Action Alert: Aquestive, BMS, GBT and Strongbridge/Xeris

  12/20/2021

  Although the U.S. FDA largely cleared its calendar ahead of the holidays, it still has a couple open PDUFA dates leading up to January 1, 2022. Here’s a look.

• Strongbridge Biopharma plc Announces Completion of Acquisition by Xeris Pharmaceuticals, Inc.

  10/5/2021

  Strongbridge Biopharma plc (NASDAQ: SBBP) (the “Company” or “Strongbridge”) today announced that the High Court of Ireland (the "Court") has approved the previously announced proposed acquisition of Strongbridge by Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) (“Xeris”) by means of a scheme of arrangement (the "Scheme") under Chapter 1 of Part 9 of the Irish Companies Act 2014 (the "Act").

• Strongbridge Biopharma plc Announces Court Hearing Date to Approve Proposed Acquisition by Xeris Pharmaceuticals, Inc.

  9/23/2021

  Strongbridge Biopharma plc (NASDAQ: SBBP) (the “Company” or “Strongbridge”) today announced that the High Court of Ireland (the “Court”) has set the date of the final court hearing to sanction the proposed acquisition of Strongbridge by Xeris Pharmaceuticals, Inc. (“Xeris”) by means of scheme of arrangement (the “Scheme”) under Chapter 1 of Part 9 of the Irish Companies Act 2014 (the “Act”).

• Xeris Pharmaceuticals Stockholders Approve Acquisition of Strongbridge Biopharma

  9/14/2021

  Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) (“Xeris”) today announced that its stockholders have voted to approve the previously announced proposed acquisition of Strongbridge Biopharma plc (NASDAQ: SBBP) (“Strongbridge”) by Xeris.

• Strongbridge Biopharma plc Announces Shareholder Approval of Proposed Acquisition by Xeris Pharmaceuticals, Inc.

  9/8/2021

  Strongbridge Biopharma plc announced that its shareholders have voted to approve the previously announced proposed acquisition of Strongbridge by Xeris Pharmaceuticals, Inc. .

• Second Leading Independent Proxy Advisory Firm Glass Lewis Recommends Strongbridge Biopharma plc Shareholders Vote “FOR” the Transaction With Xeris

  8/31/2021

  Glass Lewis Joins ISS in Recommending Strongbridge Shareholders Vote “FOR” Transaction with Xeris Strongbridge Urges Shareholders to Vote “FOR” All Transaction-Related Proposals

• Xeris Pharmaceuticals Announces Leading Independent Proxy Advisory Firm, ISS, Recommends Xeris Stockholders Vote “FOR” the Transaction With Strongbridge Biopharma

  8/30/2021

  Xeris Pharmaceuticals, Inc. (Nasdaq: XERS) today announced that a leading independent proxy advisory firm Institutional Shareholder Services (“ISS”) has recommended that Xeris stockholders vote “FOR” all proposals related to the Company’s transaction with Strongbridge Biopharma plc

• Leading Independent Proxy Advisory Firm ISS Recommends Strongbridge Biopharma plc Shareholders Vote “FOR” the Transaction With XerisStrongbridge Urges Shareholders to Vote “FOR” All Transaction-Related Proposals

  8/30/2021

  Strongbridge Biopharma plc (Nasdaq: SBBP) (“Strongbridge”) today announced that the leading independent proxy advisory firm Institutional Shareholder Services (“ISS”) has recommended that Strongbridge shareholders vote “FOR” the Company’s transaction with Xeris Pharmaceuticals (Nasdaq: XERS) (“Xeris”).

• Strongbridge Biopharma plc Reports Second Quarter 2021 Financial Results and Provides Corporate Update

  8/5/2021

  Strongbridge Biopharma plc, today reported financial results for the second quarter of 2021 and provided a corporate update.

• Strongbridge Biopharma plc Announces Commencement of Mailing of Proxy Statement

  8/2/2021

  Strongbridge Biopharma plc today announced that the definitive joint proxy statement/prospectus of Strongbridge (the “Proxy Statement”), which also constitutes a scheme circular under Irish law, is being sent as of July 30, 2021 to Strongbridge shareholders.

• Strongbridge Biopharma plc to Report Second Quarter 2021 Financial Results on August 5, 2021

  7/29/2021

  Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it will report the Company’s second quarter 2021 financial results and corporate highlights on August 5, 2021 at 7:30 a.m. ET.

• Strongbridge Biopharma plc Announces Dates of Special Shareholder Meetings in Connection with the Proposed Acquisition by Xeris Pharmaceuticals, Inc.

  7/26/2021

  Strongbridge Biopharma plc (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that, following a hearing before the Irish High Court, it has scheduled special shareholder meetings for Wednesday, September 8, 2021, in connection with the proposed acquisition of Strongbridge by Xeris Pharmaceuticals, Inc.

• Strongbridge Biopharma plc Announces Publication of Long-term Efficacy and Safety Results for KEVEYIS® (dichlorphenamide) for the Treatment of Primary Periodic Paralysis in Muscle & Nerve

  7/13/2021

  Strongbridge Biopharma plc, today announced that post hoc analyses from a one year open-label study evaluating daily use of KEVEYIS®.

• Strongbridge Biopharma plc Announces Issuance of Patent for RECORLEV® (levoketoconazole) for the Treatment of Cushing’s Syndrome

  6/3/2021

  Strongbridge Biopharma plc, (Nasdaq: SBBP), today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,020,393 entitled, “Methods of Treating Disease with Levoketoconazole”

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  FDA Receives Slew of New Drug Applications for Bipolar Disorder, Opioid Disorder and Rare Disease

  5/19/2021

  Several biopharmaceutical companies have submitted NDAs to the U.S. FDA covering treatment indications ranging from an opioid overdose, bipolar disorder and rare disease.

• Strongbridge Biopharma plc Announces U.S. Food & Drug Administration (FDA) Filing Acceptance of New Drug Application (NDA) for RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome

  5/13/2021

  Strongbridge Biopharma plc, a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, announced that the U.S. Food and Drug Administration has accepted for review the Company’s New Drug Application for RECORLEV® for the treatment of endogenous Cushing’s syndrome.

• Strongbridge Biopharma plc Reports First Quarter 2021 Financial Results and Provides Corporate Update

  5/12/2021

  ~ 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 KEVEYIS ® (dichlorphenamide) Revenue Guidance of Approximately $34 Million to $36 Million ~ ~ Awaiting Day 74 Letter from U.S. Food & Drug Administration (FDA) for the Company’s New Drug Application (NDA)

• Strongbridge Biopharma plc to Host First Quarter 2021 Financial Results Conference Call on May 12, 2021

  5/6/2021

  Strongbridge Biopharma plc, (Nasdaq: SBBP), a global commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs, today announced that it will host a conference call with members of Strongbridge’s management team on May 12, 2021 at 8:30 a.m. ET to discuss the Company’s first quarter 2021 financial results and corporate highlights.

• Strongbridge Biopharma plc Announces Publication of Diabetes Subgroup Analysis from Phase 3 SONICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome in Frontiers in Endocrinology

  4/7/2021

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

• Strongbridge Biopharma plc Presents Detailed Results from Pivotal Phase 3 LOGICS Study of RECORLEV® (levoketoconazole) for the Treatment of Endogenous Cushing’s Syndrome at the 2021 Annual Meeting of the Endocrine Society (ENDO)

  3/20/2021

  Strongbridge Recently Submitted a New Drug Application (NDA) for RECORLEV® (levoketoconazole) to the U.S. Food & Drug Administration