PTC Therapeutics, Sunfish Milestone Payment, Analysts Opinion, and October PDUFA Date
NEW YORK,
NY / ACCESSWIRE / October 16, 2017 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies is issuing a comprehensive report with no obligation on PTC Therapeutics, Inc. (NASDAQ: PTCT), a global biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines using its expertise in RNA biology. PTC’s internally discovered pipeline addresses multiple therapeutic areas, including rare disorders and oncology.
On October 12th, 2017, PTC announced that its joint development program in Spinal Muscular Atrophy (SMA) with Roche and the SMA Foundation (SMAF) transitioned into the pivotal part of the study evaluating the efficacy and safety of RG7916 in pediatric and adult Type 2/3 SMA patients.
The study, named SUNFISH, consists of two parts, an exploratory dose-finding part (Part 1) for 12-weeks which has been concluded, and a confirmatory part (Part 2) for 24-months. The initiation of Part 2 triggers a milestone payment to PTC from Roche. SMA is a rare genetic disorder that results in neuromuscular disability and is the leading genetic cause of mortality in infants and young children.
How much of milestone payment did PTCT
get and what do the analysts say? READ MORE
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Meanwhile, PTC Therapeutics is trying to get another drug, Translarna (ataluren), approved for Duchenne muscular dystrophy in the USA. The FDA already held its AdCom on September 28, 2017 to discuss the NDA. It has assigned the New Drug Application (NDA) for ataluren (Translarna™) a Prescription Drug User Fee Act (PDUFA) date.
The European Medicines Agency already approved Translarna in 2014, with the condition that PTC Therapeutics should submit additional data on a yearly basis. The key driver for the approval was that the expected benefits of Translarna were relatively higher than its potential risks. Following this decision, PTC was allowed to market Translarna as an orphan drug in the Europe.
When is the PDUFA date for Translarna
and what else is in the PTCT pipeline? READ MORE
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