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News Breaks
June 27, 2014
07:17 EDTVRTXVertex receives European CHMP 'positive opinion' for KALYDECO
Vertex announced that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. The CHMP opinion is based on previously announced data from the first part of a Phase 3, two-part, randomized, double-blind, placebo-controlled, cross-over study of 39 people with CF ages 6 and older who have a non-G551D gating mutation. The first part of the study showed statistically significant improvements in lung function, sweat chloride, BMI and CFQ-R scores. Data from the second part of the study were presented at the European Cystic Fibrosis Society Conference and showed that these improvements were maintained through 24 weeks of treatment with ivacaftor. The safety profile was similar to prior Phase 3 studies of ivacaftor in people with the G551D mutation. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the E.U. The European Commission generally follows the recommendation of the CHMP and typically issues marketing approval within three to four months. The CHMP also issued a positive opinion recommending the inclusion of data from the long-term follow-up PERSIST study in the KALYDECO label
News For VRTX From The Last 14 Days
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February 25, 2015
06:14 EDTVRTXPTC Therapeutics takeout price likely tops $100/share, said Credit Suisse
Credit Suisse yesterday raised its price target for PTC Therapeutics (PTCT) shares to $100 from $66 after Reuters reported the drug market is starting a sale process with Shire (SHPG) and Biomarin (BMRN) as possible suitors. The firm believes a takeout is a likely outcome before or after data the Phase III data expected to be announced in October. PTC has Translarna Phase III trials ongoing in Duchenne muscular dystrophy and cystic fibrosis to support full approval in the U.S. Credit Suisse said yesterday in a note to investors that a takeout value for the company likely exceeds $100 per share. It believes PTC would be a good fit for Vertex (VRTX), Biogen (BIIB), Roche (RHHBY) and others. The firm kept an Outperform rating on the stock. PTC Therapeutics shares closed yesterday up $6.20 to $71.16.
February 18, 2015
09:04 EDTVRTXVertex data likely to show lung function improvement, says JMP Securities
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