PTC Therapeutics (PTCT) Tops Q1 EPS by 4c; Says Actively Pursuing Global Translarna Approvals in DMD

PTC Therapeutics (NASDAQ: PTCT) reported Q1 EPS of ($1.22), $0.04 better than the analyst estimate of ($1.26). Revenue for the quarter came in at $18.9 million versus the consensus estimate of $13.74 million.

Actively pursuing regulatory approvals for Translarna in DMD globally. PTC has engaged in dialogue with the U.S. Food and Drug Administration (FDA) to discuss the matters described in the Agency's Refuse to File letter regarding Translarna for nonsense mutation Duchenne muscular dystrophy (nmDMD) and to seek a potential path forward to bring Translarna to patients in the U.S. Given the sensitivity around these discussions as well as their iterative nature, PTC will provide an update once it has clarified the regulatory strategy for Translarna in the U.S.

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