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Spark Therapeutics Inc (ONCE.OQ)

ONCE.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Pfizer Initiates Pivotal Phase 3 Program For Investigational Hemophilia B Gene Therapy
Monday, 16 Jul 2018 

July 16 (Reuters) - Pfizer Inc ::PFIZER INITIATES PIVOTAL PHASE 3 PROGRAM FOR INVESTIGATIONAL HEMOPHILIA B GENE THERAPY.  Full Article

Spark Therapeutics Says Entered Into Asset Purchase Agreement With Jazz Pharmaceuticals Ireland Ltd
Monday, 30 Apr 2018 

April 30 (Reuters) - Spark Therapeutics Inc ::SPARK THERAPEUTICS SAYS ENTERED INTO ASSET PURCHASE AGREEMENT WITH JAZZ PHARMACEUTICALS IRELAND LIMITED - SEC FILING.SPARK THERAPEUTICS - PURSUANT TO AGREEMENT CO AGREED TO SELL RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER.SPARK THERAPEUTICS - JAZZ WILL PAY CO $110 MILLION FOR PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER UPON CLOSING OF PURCHASE - SEC FILING.  Full Article

Children's Hospital Of Philadelphia Foundation To Engage In Dialogue With Spark Therapeutics To Be Allowed To Designate At Least 1 Board Member
Friday, 9 Mar 2018 

March 9 (Reuters) - Spark Therapeutics Inc ::CHILDREN'S HOSPITAL OF PHILADELPHIA FOUNDATION - TO ENGAGE IN DIALOGUE WITH SPARK THERAPEUTICS TO BE ALLOWED TO DESIGNATE AT LEAST 1 BOARD MEMBER.‍CHILDREN'S HOSPITAL OF PHILADELPHIA FOUNDATION​ - PLANS TO EXPRESS CONCERNS WITH SPARK'S CORPORATE GOVERNANCE PRACTICES IN ONGOING DIALOGUE.THE CHILDREN’S HOSPITAL OF PHILADELPHIA FOUNDATION REPORTS 10.7 PERCENT STAKE IN SPARK THERAPEUTICS AS OF MARCH 9, 2018 - SEC FILING.CHILDREN'S HOSPITAL OF PHILADELPHIA FOUNDATION - TO CONSIDER VIEW OF ISS, AMONG OTHERS REGARDING ELECTION OF SPARK THERAPEUTICS' BOARD AT 2018 MEETING.CHILDREN'S HOSPITAL OF PHILADELPHIA FOUNDATION - NOT YET DECIDED HOW IT WILL VOTE ITS SHARES AT SPARK THERAPEUTICS' 2018 STOCKHOLDERS MEETING.  Full Article

Spark Therapeutics To Begin Program In Pompe Disease
Monday, 8 Jan 2018 

Jan 8 (Reuters) - Spark Therapeutics ::SPARK THERAPEUTICS CEO SAYS PLANS TO BEGIN PROGRAM IN POMPE DISEASE.SPARK CEO SAYS EXPECTS LUXTURNA GENE THERAPY TO BE AVAILABLE TO PATIENTS IN EUROPE IN 2019.  Full Article

Spark Therapeutics - On Jan 3, 2018, Co Announced Wholesale Acquisition Cost For Luxturna Is $425,000/Dose
Wednesday, 3 Jan 2018 

Jan 3 (Reuters) - Spark Therapeutics Inc ::SPARK THERAPEUTICS - ON JAN 3, 2018, CO ANNOUNCED WHOLESALE ACQUISITION COST FOR LUXTURNA (VORETIGENE NEPARVOVEC-RZYL) IS $425,000/DOSE OR PER EYE.  Full Article

FDA Approves Luxturna, A Gene Therapy To Treat A Rare Form Of Vision Loss
Tuesday, 19 Dec 2017 

Dec 19 (Reuters) - U.S. Food and Drug Administration::U.S. FDA SAYS APPROVES LUXTURNA (VORETIGENE NEPARVOVEC-RZYL), A GENE THERAPY TO TREAT PATIENTS WITH A RARE FORM OF INHERITED VISION LOSS.U.S FDA SAYS GRANTED APPROVAL OF LUXTURNA TO SPARK THERAPEUTICS INC.U.S. FDA SAYS LUXTURNA IS APPROVED FOR THE TREATMENT OF PATIENTS WITH CONFIRMED BIALLELIC RPE65 MUTATION-ASSOCIATED RETINAL DYSTROPHY.  Full Article

Spark Therapeutics reports Q3 loss per share $1.90
Tuesday, 7 Nov 2017 

Nov 7 (Reuters) - Spark Therapeutics Inc :Spark Therapeutics Inc reports third quarter 2017 financial results and recent business progress.Q3 loss per share $1.90.Q3 earnings per share view $-1.81 -- Thomson Reuters I/B/E/S.  Full Article

Spark Therapeutics and Pfizer amend license agreement for investigational SPK-9001 in hemophilia B
Tuesday, 7 Nov 2017 

Nov 7 (Reuters) - Spark Therapeutics Inc :Spark Therapeutics and Pfizer amend license agreement for investigational SPK-9001 in hemophilia B.Spark Therapeutics Inc - Co transferring enhanced SPK-9001 manufacturing process to Pfizer.Spark Therapeutics - Co, Pfizer ‍have entered into amendment to their license agreement for SPK-9001.Spark Therapeutics - ‍Subject to terms of amendment, Spark Therapeutics will receive from pfizer an initial $10 million cash payment​.Spark Therapeutics Inc - Will enroll up to five additional participants in current phase 1/2 clinical trial​.Spark - ‍Subject to amendment, to receive from Pfizer up to additional $15 million in potential milestone payments upon completion of transition activities​.Spark Therapeutics - ‍Activities outlined in amended agreement will occur parallel to Pfizer's ongoing preparation to assume responsibility for SPK-9001.  Full Article

Spark Therapeutics says NASDAQ halts trading of its common stock
Thursday, 12 Oct 2017 

Oct 12 (Reuters) - Spark Therapeutics Inc : :Spark Therapeutics (once) trading of stock halted as FDA advisory committee reviews investigational gene therapy.Spark Therapeutics Inc - U.S. ‍FDA's cellular, tissue and gene therapies advisory committee is meeting today to review LUXTURNA (voretigene neparvovec)​.Spark Therapeutics Inc - ‍LUXTURNA is under priority review with FDA, with an assigned prescription drug user fee act (PDUFA) date of jan. 12, 2018​.  Full Article

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With Hemlibra, Roche seeks to break into tight hemophilia circle

ZURICH Swiss drugmaker Roche is breaking into hemophilia A treatment, a $10 billion (£7.70 billion) global market dominated by rivals who have cultivated close ties to sufferers of the genetic bleeding disorder.