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Strongbridge Biopharma plc Reports First Quarter 2019 Financial Results and Provides Corporate Update
~ Following Type C Meeting with the U.S. Food & Drug Administration (FDA), Strongbridge Plans to Submit its New Drug Application (NDA) for RECORLEV (levoketoconazole) in the Third Quarter of 2020; Submission to Include Data From the Phase 3 SONICS and LOGICS Studies ~
~ Newly Presented Data from the Phase 3 SONICS Study Reinforce the Potential Clinical Benefit and Role of RECORLEV in the Treatment of Patients with Endogenous Cushings Syndrome ~
~ KEVEYIS® (dichlorphenamide) First Quarter 2019 Revenue of $4.3 Million On Track with Full-Year 2019 KEVEYIS® Revenue Guidance of $18 to $20 Million ~
Dublin, Ireland and Trevose, Pa., May 1, 2019 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 reported financial results for the first quarter of 2019 and provided a corporate update.
During the first quarter of 2019, we held a Type C meeting with the FDA to seek their guidance on the regulatory pathway for RECORLEV (levoketoconazole). In line with feedback from the FDA, we have concluded that submitting a New Drug Application (NDA) inclusive of data from both the Phase 3 SONICS and LOGICS studies is the optimal path forward, said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. The LOGICS study is progressing well; however, due to slower than anticipated enrollment, we now expect to receive top-line results by the end of the first quarter of 2020. Despite this shift in timing, we are pleased to report that with the additional clarity from the FDA and review of our timelines, we now plan to submit an NDA by the end of the third quarter of 2020.
First Quarter 2019 and Recent Corporate & Financial Highlights
Rare Endocrine Franchise: RECORLEV (levoketoconazole)
· The Company held a Type C meeting with the FDA to seek guidance on the regulatory path forward to obtain U.S. marketing approval for RECORLEV for the treatment of endogenous Cushings syndrome. In line with the Agencys feedback, Strongbridge plans to submit its New Drug Application (NDA) with data from both the Phase 3 SONICS and LOGICS studies by the end of the third quarter of 2020.
The following information was filed by Strongbridge Biopharma Plc (SBBP) on Wednesday, May 1, 2019 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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