|January 24, 2014|
|07:23 EDT||PTCT||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
Check below for free stories on PTCT the last two weeks.
|September 22, 2014|
|10:35 EDT||PTCT||PTC Therapeutics management to meet with Roth Capital|
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|September 17, 2014|
|08:04 EDT||PTCT||PTC Therapeutics prepares launch of Translarna in Europe |
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|September 15, 2014|
|09:59 EDT||PTCT||On The Fly: Analyst Initiation Summary|
Today's noteworthy initiations include: American Realty (ARCP) initiated with an Overweight at JPMorgan... Athlon Energy (ATHL) initiated with a Buy at KLR Group... Capital Product (CPLP) initiated with a Buy at Jefferies... Continental Resources (CLR) initiated with a Buy at Canaccord... Costco (COST) initiated with a Buy at Citigroup... Infinera (INFN) initiated with an Outperform at Barrington... NRG Yield (NYLD) initiated with an Outperform at RBC Capital... PTC Therapeutics (PTCT) initiated with a Buy at Deutsche Bank... Power Solutions (PSIX) initiated with an Outperform at Northland... ServiceNow (NOW) initiated with an Outperform at William Blair... Target (TGT) initiated with a Neutral at Citigroup... Team (TISI) initiated with a Neutral at Sidoti... VeriFone (PAY) initiated with a Buy at Monness Crespi... Wal-Mart (WMT) initiated with a Neutral at Citigroup... Whiting Petroleum (WLL) initiated with a Buy at Canaccord... Winnebago (WGO) initiated with an Outperform at BMO Capital.
|05:45 EDT||PTCT||PTC Therapeutics initiated with a Buy at Deutsche Bank|
|September 9, 2014|
|08:07 EDT||PTCT||PTC Therapeutics completes enrollment of Phase 3 trial of Translarna|
PTC Therapeutics announced that it has completed enrollment of ACT DMD, the Phase 3 confirmatory trial of Translarna, or ataluren, for patients with nonsense mutation Duchenne muscular dystrophy, or nmDMD. Top-line data from the trial is expected in the second half of 2015 and will support further approvals globally, following European approval received earlier this year.