FDA denies approval of PTC Therapeutics' vatiquinone NDA for Friedreich's ataxia

PTC THERAPEUTICS, INC.

FDA CRL states substantial evidence of efficacy not demonstrated; additional well-controlled study needed for resubmission.
PTC plans to meet with FDA to discuss potential steps to address CRL issues.
Vatiquinone was proposed for children and adults with Friedreich's ataxia.
CEO Matthew B. Klein expressed disappointment but believes data support safe, effective therapy.

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