PTC Therapeutics (NASDAQ: PTCT) reported 3Q15 EPS of $(1.27), vs consensus $(1.14). Translarna revenues were $9.8MM, a 59% QoQ growth in sales, vs consensus of $10.4MM.

Investor focus is on if FDA accepts Translarna's rolling NDA (which we think is very likely, target completion YE2015). We think Translarna has a real chance at approval given very clean safety and likely flexible FDA review.

Cowen analyst, Ritu Baral, noted: "Translarna sales increased by 59% QoQ, partially attributable to increased physician confidence in Translarna clinical benefit after Ph3 ACT-DMD data release which showed stat sig efficacy in select prespecified patient subgroups and prespecified meta-analysis. Of note, sales growth was largely attributable to an increase in uptake within European geographies, rather than addition of new sales-generating countries (only Sweden was added in 3Q)."

No change to Outperform rating or $120 PT

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Shares of PTC Therapeutics closed at $27.46 yesterday.