Fly News Breaks for February 26, 2015
PTCT
Feb 26, 2015 | 09:36 EDT
Oppenheimer more than doubled its price target for PTC Therapeutics shares to $135 on expectations for successful Phase III data in October and subsequent FDA approval of Translarna in patients with Duchenne muscular dystrophy. Ocpo views the Phase III data readout and approval as fundamental value drivers for the company in the next 12-months, irrespective of the recent takeout speculation. Shares of PTC are trading down 26c to $73.33 in early trading.
News For PTCT From the Last 2 Days
PTCT
Mar 28, 2024 | 08:34 EDT
PTC Therapeutics submitted the sepiapterin MAA to the European Medicines Agency, or EMA. The MAA submission is for the treatment of pediatric and adult patients with Phenylketonuria, including the full spectrum of disease subtypes. Phenylketonuria, or PKU, is a rare, inherited metabolic disease, which affects the brain. The sepiapterin MAA includes the results of the phase 3 APHENITY trial in which sepiapterin had a statistically significant and clinically meaningful reduction in blood phenylalanine levels in pediatric and adult PKU patients. PTC expects to submit the sepiapterin NDA to the FDA no later than the third quarter of 2024. Submissions in 2024 are planned in a number of additional key countries where PTC has existing rare disease commercial infrastructure including Brazil and Japan.