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Stock Market & Financial Investment News

News Breaks
January 24, 2014
07:23 EDTPTCTPTC 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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May 21, 2015
18:49 EDTPTCTOn The Fly: After Hours Movers
UP AFTER EARNINGS: Hewlett-Packard (HPQ), up 1%. ALSO HIGHER: Autobytel (ABTL), up 14.1% after acquiring Dealix Corporation and Autotegrity from CDK Global (CDK) for $25M and raising fiscal 2015 guidance... StemCells (STEM), up 2.5% after being initiated with a Buy at Cantor... PTC Therapeutics (PTCT), up 2.3% after a Benefit Assessment by Germany's Federal Joint Committee indicated that Translarna provided a benefit for ambulatory patients... CBOE Holdings (CBOE), up 1.6% after raising share repurchase authorization by $100M... Cypress Semiconductor (CY), up 1.2% after being initiated with a Buy at Mizuho. DOWN AFTER EARNINGS: Aeropostale (ARO), down 18.5%... Brocade (BRCD), down 2.1%... Marvell Technology (MRVL), down 2.9% after reporting quarterly results and departure of CFO. ALSO LOWER: Otonomy (OTIC), down 17.7% following report of Phase 2b topline data for OTO-104... Viggle (VGGL), down 18.8% after filing to sell common stock... CEL-SCI (CVM),down 2.7% after announcing a proposed offering of common stock and warrants.
16:06 EDTPTCTPTC says assessment showed Translarna provided benefit for ambulatory patients
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