PTCT - Why Is Gene Therapy Player PTC Therapeutics Stock Plunging Today? | Benzinga
In its Q3 earnings release, PTC Therapeutics Inc (NASDAQ: PTCT) reported a delay to the planned submission of sepiapterin in phenylketonuria (PKU).
PTC planned to file for FDA approval in the fourth quarter. But, the FDA pushed the timeline at a recent meeting, informing PTC that it needs to complete a 26-week nonclinical mouse study before seeking authorization.
PTC explained that the original plan was to seek approval under the 505(b)(2) pathway, which would have allowed the company to use data on a different reference drug to support its application.
However, PTC changed to the 505(b)(1) pathway after buying the candidate from Censa Pharmaceuticals.
In a written ...