Business
PTC Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results
– Continued strong revenue performance – – NDAs for sepiapterin and Translarna™ submitted to FDA – – Positive interim data readout from PTC518 PIVOT-HD study
About this update from Ptc Therapeutics, Inc.
[{"type":"text","content":"– Continued strong revenue performance –\n– NDAs for sepiapterin and Translarna™ submitted to FDA –\n– Positive interim data readout from PTC518 PIVOT-HD study –\n– On track to achieve remaining 2024 clinical and regulatory milestones –\nWARREN, N.J., Aug. 8, 2024 /PRNewswire/ -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced a corporate update and financial results for the second quarter ending June 30, 2024. \n\n\"I am proud of our team's continued outstanding execution as we have accomplished all our objectives so far this year,\" said Matthew Klein, M.D., Chief Executive Officer. \"We are in a strong cash position, submitted three drug approval applications to the FDA and remain on schedule to achieve the many milestones we have set for the remainder of 2024.\" \nKey Corporate Updates: \nSecond quarter 2024 total revenue of $187 millionSecond quarter 2024 revenue for the DMD franchise was $118 millionTranslarna™ (ataluren) net product revenue was $70 million, driven by continued access for patients in existing geographies and continued geographic expansion.Emflaza® (deflazacort) net product revenue was $47 million, driven by new patient starts and continued brand loyalty.Key Clinical and Regulatory Milestones: \nPTC submitted an NDA to the FDA for sepiapterin for the treatment of PKU in July 2024. Further regulatory submissions are planned for Japan and Brazil later in 2024.PTC resubmitted the NDA for Translarna for the treatment of nmDMD in July 2024.PTC achieved all objectives in the interim readout of the Phase 2 PIVOT-HD study of PTC518 in Huntington's disease patients, which were disclosed in the second quarter.PTC plans to submit an NDA for vatiquinone for the treatment of Friedreich ataxia in late 2024.PTC expects to share topline data for the CardinALS trial of utreloxastat for the treatment of ALS in the fourth quarter of 2024.The BLA for PTC's gene therapy for AADC deficiency was accepted by FDA with priority review; the target regulatory action date is November 13, 2024.Second-Quarter 2024 Financial Highlights: \nTotal revenues were $186.7 million for the second quarter of 2024, compared to $213.8 million for the second quarter of 2023.Total revenues include net product revenue across the commercial portfolio of $133.2 million for the second quarter of 2024, compared to $174.6 million for the second quarte...