PTC Therapeutics: EMA adopted negative opinion on MAA for Atuluren approval PTC Therapeutics announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a negative opinion on the company's marketing authorization application for conditional approval of ataluren for the treatment of nonsense mutation Duchenne muscular dystrophy. The response from the CHMP is consistent with the company's previous guidance concerning the substantial risks regarding conditional EMA approval and underscores the importance of PTC's work in completing the ongoing confirmatory Phase 3 clinical trial. In April 2013, PTC initiated a 48-week, 220-patient confirmatory Phase 3 clinical trial of ataluren for the treatment of nmDMD. The trial is on track to complete enrollment in mid-2014 with top-line data expected in mid-2015. PTC intends to request a re-examination of the CHMP opinion with a final outcome expected in the second quarter of 2014, when the confirmatory study is expected to be more fully enrolled.
News For PTCT From The Last 14 Days
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On The Fly: Analyst Initiation Summary Today's noteworthy initiations include: Abengoa Yield (ABY) initiated with an Equal Weight at Morgan Stanley... Actinium Pharmaceuticals (ATNM) initiated with a Buy at Canaccord... Axys Technologies (AXYS) initiated with a Buy at Dougherty... Chambers Street Properties (CSG) initiated with a Neutral at SunTrust... Enphase Energy (ENPH) initiated with a Buy at Dougherty... Minerals Technologies (MTX) initiated with an Outperform at Wedbush... NextEra Energy Partners (NEP) initiated with a Buy at BofA/Merrill... PTC Therapeutics (PTCT) initiated with a Buy at BofA/Merrill... QIWI (QIWI) initiated with a Positive at Susquehanna... Quality Systems (QSII) initiated with a Buy at Topeka... Sarepta (SRPT) initiated with a Neutral at BofA/Merrill... Trinseo S.A. (TSE) initiated with a Buy at BofA/Merrill... Washington Prime Group (WPG) initiated with a Neutral at SunTrust... Zhaopin (ZPIN) initiated with a Buy at UBS.