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Spark Therapeutics shares jump 7.5% after FDA committee backs blindness treatment

Shares of Spark Therapeutics Inc. surged 7.5% premarket Friday, after a U.S. Food and Drugs Administration advisory committee recommended approval of the company's gene therapy treatment for a rare eye disease that causes blindness. .....»»

Category: topSource: marketwatchOct 13th, 2017

Spark Therapeutics shares halted as FDA committee reviews gene therapy treatment for eye disease

Spark Therapeutics Inc. shares were halted Thursday as a U.S. Food and Drugs Administration advisory committee meets to review the company's gene therapy treatment for patients with vision loss caused.....»»

Category: topSource: marketwatchOct 12th, 2017

All The Sell-Side Responses To Spark Therapeutics" Strong AdCom Meeting On Luxturna

On Thursday afternoon, and FDA advisory panel recommended approval of Spark Therapeutics Inc (NASDAQ: ONCE)’s Luxturna treatment for inherited blindness. Latest Ratings for ONCE.....»»

Category: blogSource: benzingaOct 13th, 2017

Spark Therapeutics shares halted as FDA advisory committee reviews gene therapy

This is a Real-time headline. These are breaking news, delivered the minute it happens, delivered ticker-tape style. Visit www.marketwatch.com or the quote page for more information about this breaking news......»»

Category: topSource: marketwatchOct 12th, 2017

Spark Therapeutics applies to market investigational therapy in Europe

The gene therapy company that spun out of Children's Hospital of Philadelphia is moving forward with a regulatory review of its treatment of an inherited disease that leads to blindness in Europe – laying the groundwork for the investigational therapy .....»»

Category: topSource: bizjournalsJul 31st, 2017

Why Spark"s CEO says 2017 may be a "historic year" for his gene therapy company

Philadelphia gene therapy company Spark Therapeutics said it is in the final stages of completing its rolling biologics license application for its lead product: a one-time treatment for an inherited retinal disease that causes blindness in children.....»»

Category: topSource: bizjournalsFeb 22nd, 2017

Pluristem shares jump 5.4% premarket as FDA approves trial of treatment for critical limb ischemia

Pluristem Therapeutics Inc. shares surged 5.4% in premarket trade Tuesday, after the company said the U.S. Food and Drug Administration has granted approval for a late-stage trial of PLX-PAD cells in the treatme.....»»

Category: topSource: marketwatchJan 10th, 2017

Therapy to treat blindness may become reality soon

The approval of Spark Therapeutics Inc's Luxturna therapy would pave the way for new payment models for drugs, particularly in the US.....»»

Category: topSource: business-standardOct 14th, 2017

Is Spark Therapeutics’ Luxturna a Game Changer?

Shares of Spark Therapeutics saw a handy gain to close out the week after the FDA recommended approval of Luxturna......»»

Category: blogSource: 247wallstOct 13th, 2017

Spark: A Big Win for Gene Therapy. So Why Is It Falling?

Shares of Spark Therapeutics are down today, despite winning the recommendation of a FDA advisory panel for its experimental gene therapy......»»

Category: blogSource: barronsOct 13th, 2017

Aerie Pharmaceuticals stock halted for FDA committee review of glaucoma treatment

Shares of Aerie Pharmaceuticals Inc. were halted for trading Friday, as the U.S. Food and Drugs Administration reviews a new drug application for .....»»

Category: topSource: marketwatchOct 13th, 2017

A first-of-its-kind treatment for blindness just got one step closer to approval

AP A US Food and Drug Administration (FDA) advisory committee just gave a critical recommendation for a cutting-edge gene therapy.  The treatment, called Luxturna, treats Leber congenital amaurosis,&nbs.....»»

Category: topSource: businessinsiderOct 12th, 2017

FDA advisory panel recommends approval of Spark Therapeutics" gene therapy

A Food and Drug Administration advisory committee voted Thursday to recommend approval of Spark Therapeutics’ application for its experimental gene therapy developed to treat vision loss caused by an inherited retinal disease. The company, which .....»»

Category: topSource: bizjournalsOct 12th, 2017

UPDATE: Alnylam shares jump 24% on positive results from late-stage trial of hATTR amyloidosis treatment

Sanofi and Alnylam Pharmaceuticals Inc. on Wednesday reported positive results in a late-stage trial of a treatment for.....»»

Category: topSource: marketwatchSep 20th, 2017

UPDATE: Nabriva Therapeutics stock jumps 102% premarket on positive trial of pneumonia treatment

Nabriva Therapeutics plc shares surged 102% in premarket trade Monday, after the company reported positive results from a late-stage trial of a treatment for community-acquired bacterial pneumonia, or CAB.....»»

Category: topSource: marketwatchSep 18th, 2017

UPDATE: Pluristem stock jumps 21% premarket after FDA grants CLI treatment fast-track designation

Shares of Israeli biotech Pluristem Therapeutics Inc. jumped 21% in premarket trade Monday, after the company was awarded fast-track designation by the U.S. Food and Drug Administration for a treat.....»»

Category: topSource: marketwatchSep 18th, 2017

UPDATE: Nabriva Therapeutics stock jumps 82% premarket on positive trial of pneumonia treatment

Nabriva Therapeutics plc shares surged 82% in premarket trade Monday, after the company reported positive results from a late-stage trial of a treatment for community-acquired bacterial pneumonia, or CAB.....»»

Category: topSource: marketwatchSep 18th, 2017

Mirati Therapeutics" stock soars on heavy volume after positive cancer treatment trial results

Shares of Mirati Therapeutics Inc. rocketed 82% toward a 15-month high in active premarket trade Friday, after the biotechnology company announced positive data from two trials of its lung cancer treatment.....»»

Category: topSource: marketwatchSep 15th, 2017

Sage Therapeutics Falls Hard After Brexanolone Drug Fails Phase III Testing

Shares of SAGE Therapeutics Inc (NASDAQ: SAGE) plunged Tuesday after the biopharma company announced its treatment for super-refractory status epilepticus failed its phase III trial. Latest Ratin.....»»

Category: blogSource: benzingaSep 12th, 2017

Sage Therapeutics Gets a Dunce Hat

Sage Therapeutics saw its shares drop by about a quarter early on Tuesday after the firm gave an update on its late-stage study trial in the treatment super-refractory status epilepticus......»»

Category: blogSource: 247wallstSep 12th, 2017

Sage Therapeutics" stock sinks after disappointing late-stage trial of SRSE treatment

Shares of Sage Therapeutics Inc. sank 24% in active premarket trade Tu.....»»

Category: topSource: marketwatchSep 12th, 2017