Exhibit 99.1

 

 

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 Cushing’s 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 Cushing’s syndrome. In line with the Agency’s 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.

View differences made from one quarter to another to evaluate Strongbridge Biopharma Plc's financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-Q Quarterly Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Strongbridge Biopharma Plc.

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account