Tag Archives: shpg

Shire Up As Dry-Eye Drug Gets Early FDA Decision Date

Shire (SHPG) stock popped nearly 3% Thursday after the specialty drugmaker said the FDA had granted priority review to its dry-eye treatment lifitegrast. Shire said the FDA had set a deadline of Oct. 25 to make a decision on the product, which apparently was sooner than many investors had expected. The phase-three trials for the drug produced mixed results, which some analysts doubted would be sufficient for approval. In December, Leerink analyst

Amicus Up As FDA, EU Green-light Quick Drug Filings

Small biotech Amicus Therapeutics (FOLD) jumped more than 30% Thursday after the company said it would file for accelerated approval of its lead drug candidate after positive meetings with the FDA and EU authorities. Amicus’ drug migalastat would be the first oral treatment for Fabry disease, a rare but serious congenital condition currently treated with the IV drugs Fabrazyme (from Sanofi (SNY) and Replagal (from Shire (SHPG). Amicus said that

Shire Moves Up On NPS Potential; Q4 Earnings Miss

Shares of Shire (SHPG) moved higher early Thursday as the Irish drugmaker’s better-than-expected quarterly revenue and upbeat 2015 outlook offset an earnings miss. Reporting before the open, Shire logged fourth-quarter earnings of $2.63 per American depositary share, up 19% from the year-earlier period but a nickel below consensus estimates of analysts polled by Thomson Reuters. Revenue climbed 19% to $1.58 billion, topping views. It was Shire’s