PTC Therapeutics' (PTCT) Price Target Raised to $13 at RBC Capital
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RBC Capital maintained a Sector Perform rating on PTC Therapeutics (NASDAQ: PTCT) and raised its price target to $13.00 (from $5.00). Earlier CHMP recommended the renewal of the conditional marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients five years and older.
Commenting on developments, Simos Simeonidis said, "We had assigned a 50% chance that Translarna would be pulled, given its failure on the confirmatory Phase III trial. With the drug remaining on the market for at least another year, shares should trade around Translarna's ex-US value. We continue to expect negative ACT-CF and FDA news for PTCT."
The analyst added, "The company recently announced that data from ACT-CF, its Phase III study in cystic fibrosis, are now now expected late 1Q17 (vs. prior early '17). Following feedback from the FDA and the company's CHMP rapporteurs on the statistical analysis plan of ACT CF, the company has updated the trial’s design so that it is “in-line with clinical trials for other approved CF therapies”. The primary endpoint has been modified from relative to absolute change in percent predicted FEV1 (forced expiratory volume in 1 second). Management indicated that the change will not impact statistical powering of the trial, which is powered to detect a 3% absolute change in percent predicted FEV1. Top-line data from the study is guided for late 1Q17, and PTC anticipates that the CHMP may wait to see data from this study before issuing a decision on the label-extension application for CF. Based on ataluren’s failure in the first CF trial and the program’s failure in DMD, we do not currently assign any value to the CF opportunity."
Shares of PTC Therapeutics closed at $6.00 yesterday.
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