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PTC Therapeutics Reports Second Quarter 2019 Financial Results and Provides a Corporate Update
SOUTH PLAINFIELD, N.J., Aug. 6, 2019 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results
About this update from Ptc Therapeutics, Inc.
[{"type":"text","content":"SOUTH PLAINFIELD, N.J., Aug. 6, 2019 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced a corporate update and reported financial results for the second quarter ending June 30, 2019. \n\"Over the second quarter we've made important progress towards our strategic plan of building a robust diversified orphan drug franchise,\" said Stuart W. Peltz, Ph.D., CEO of PTC Therapeutics. \"We believe that one of PTC's key differentiators is our ability to work across multiple scientific platforms to bring orphan products to patients. Our 5-year vision elucidates PTC's mission of bringing differentiated therapies to patients living with rare disorders that have limited or no treatment options. By fulfilling this mission, we will be creating value for all of our stakeholders.\"\nKey Second Quarter and Other Corporate Highlights:\nCommercial portfolio\nTranslarna received approval from the Brazilian health regulatory authority (ANVISA) and subsequently, PTC has entered into its first annual contract with the Brazilian Ministry of Health. Emflaza® received FDA approval for a label expansion to include DMD patients aged 2-5 years. This demographic is estimated to comprise approximately 25% of the prevalent DMD population in the U.S. First commercial patient on Tegsedi™ in Latin America received treatment. The regulatory application submitted to the Brazilian health regulatory authority (ANVISA) was granted priority review, with expected approval by year end 2019. We are working with Akcea to review the recent clinical results for Waylivra® in Familial Partial Lipodystrophy (FPL) and we will determine the potential commercial strategy in LATAM. The CHMP adopted a negative opinion to expand the label for Translarna to include non-ambulatory DMD patients. PTC has requested a re-examination with a tentative date for an opinion in October.Advancing gene therapy portfolio & infrastructure\nPTC has signed a long-term lease agreement securing a state-of-the-art biologics facility to support the Company's expansion into multiple gene therapy programs. The facility is currently operating under cGMP standards by its current tenant, Bristol-Myers Squibb, and will be fully transitioned to PTC by mid-2020. PTC intends to consolidate its discovery and research operations in the same campus. The expected BLA for our gene therapy candidat...