News
The FDA has rejected vatiquinone, requesting that PTC run an additional study to prove the drug's efficacy prior to ...
The U.S. Food and Drug Administration has denied approval for PTC Therapeutics' oral medication for a rare genetic disorder ...
22h
InvestorsHub on MSNPTC Therapeutics Shares Drop After FDA Rejects Vatiquinone Application
PTC Therapeutics, Inc. (NASDAQ:PTCT) saw its stock slide 5% after the U.S. Food and Drug Administration (FDA) declined to ...
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.
FDA rejected PTC Therapeutics' vatiquinone for Friedreich's ataxia, citing insufficient efficacy data and requiring another ...
FDA states substantial evidence of efficacy was not demonstrated.
The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid ...
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 ...
PTC Therapeutics has long been trying to workshop its vatiquinone into a marketable treatment for Friedreich's ataxia (FA) after a phase 3 fail in 2023. | Despite missing its primary endpoint in a ...
- PTC's fourth approval application submitted to FDA in 2024 - WARREN, N.J., Dec. 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (PTCT) announced today the submission of the vatiquinone New Drug ...
PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has issued a ...
The vatiquinone NDA is the fourth approval application PTC has submitted to the FDA this year. The BLA for its AADC gene therapy was submitted in March 2024 and approved in November 2024.
Results that may be inaccessible to you are currently showing.
Hide inaccessible results