PTC Therapeutics (PTCT) on Tuesday announced that they received a complete response letter for vatiquinone in Friedreich’s ...

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

"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' ...

Morgan Stanley lowered the firm’s price target on PTC Therapeutics (PTCT) to $71 from $76 and keeps an Overweight rating on the shares after the ...

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

JPMorgan added PTC Therapeutics (PTCT) to the firm’s Analyst Focus List while keeping an Overweight rating on the shares with a $68 price target ...

WARREN, NJ, USA I August 19, 2025 I PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a ...

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.

The original NDA submission included data from the registration-directed phase 3 MOVE-FA trial as well as 2 long-term studies evaluating vatiquinone in FA.

The FDA approved Sephience - PTC's oral therapy for a rare metabolic disorder called phenylketonuria - last month, ...

The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid ...

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