PTCT - PTC Therapeutics: Multiple Regulatory Submissions Along With Data Cuts
2024-05-14 15:35:05 ET
Summary
- PTC Therapeutics, Inc. has submitted a New Drug Application for Upstaza for AADC Deficiency, with a PDUFA date set for November 13th, 2024.
- The company has several other regulatory milestones expected in 2024, including the resubmission of Translarna for DMD and the submission of vatiquinone for Friedreich's Ataxia.
- PTC Therapeutics also has two data readouts expected this year for PTC518 and utreloxastat, which could provide additional investment opportunities.
- PTC Therapeutics had $884.8 million in cash as of March 31st of 2024; Enough to fund its operations for at least the next 12 months.
PTC Therapeutics, Inc. ( PTCT ) had been able to submit its New Drug Application [NDA] to the FDA for Upstaza for AADC Deficiency in March 2024. The importance of this is that not only has the FDA accepted this NDA with Priority Review status, but has set a PDUFA date of November 13th of 2024 for it. This sets up a major catalyst for investors to focus on....
PTC Therapeutics: Multiple Regulatory Submissions Along With Data Cuts