PTC Therapeutics Announces Updates On Vatiquinone Friedreich Ataxia Program; Says Pre-Specified Endpoint For Two FA Long-Term Extension Studies Was Met, Says Co. Recently Aligned With FDA On Key Aspects On Planned NDA Submission
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PTC Therapeutics announced that its Vatiquinone Friedreich Ataxia program met the pre-specified endpoint in two long-term extension studies. The company has also aligned with the FDA on key aspects of its planned NDA submission.
October 08, 2024 | 12:03 pm
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PTC Therapeutics' Vatiquinone program for Friedreich Ataxia met key study endpoints and aligned with the FDA for NDA submission, indicating potential progress in drug approval.
The meeting of pre-specified endpoints in long-term studies is a significant milestone for drug development, suggesting efficacy and safety. Alignment with the FDA on NDA submission is crucial for regulatory approval, likely boosting investor confidence in PTCT.
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