The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient ...

PTC Therapeutics ( ($PTCT) ) has issued an update. On August 19, 2025, PTC Therapeutics announced that the FDA issued a Complete Response Letter ...

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) related to the New Drug Application (NDA) for ...

FDA states substantial evidence of efficacy was not demonstrated.

PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a ...

PTC Therapeutics yesterday revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL ...

The US Food and Drug Administration (FDA) has rejected PTC Therapeutics’ new drug application (NDA) for vatiquinone in ...

FDA rejected PTC Therapeutics' vatiquinone for Friedreich's ataxia, citing insufficient efficacy data and requiring another ...

The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...

PTC Therapeutics (NASDAQ:PTCT) stock drops as the FDA declines to approve vatiquinone, its treatment for Friedreich's ataxia, ...

"We are of course disappointed by the FDA's decision to not approve vatiquinone," said Matthew Klein, PTC's chief executive, who noted that the FDA is seeking another 'adequate and well-controlled' ...

Today, the FDA issued a complete response letter (CRL) for vatiquinone (PTC Therapeutics), delaying its potential approval as a treatment for Friedreich ataxia amid efficacy concerns.