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Fly News Breaks for October 17, 2016
PTCT
Oct 17, 2016 | 11:11 EDT
Citi analyst Joel Beatty says that while the FDA's denial of PTC Therapeutics' first appeal was widely expected, the major objection relating to the efficacy of Translarna by Europe's Committee for Medicinal Products for Human Use is more concerning. The move highlights that the CHMP is still not comfortable with the overall risk-benefit profile of Translarna ahead of an expected decision by year-end, Beatty tells investors in a research note. He sees heightened risk of Translarna's marketing authorization not being renewed in Europe and feels PTC's time is running out to alleviate CHMP's concerns. The analyst has a Neutral rating on the shares with a $9 price target. PTC is trading down 30%, or $3.94, to $9.34 in morning trading.
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