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Spark Therapeutics Inc (ONCE.OQ)

ONCE.OQ on NASDAQ Stock Exchange Global Select Market

74.03USD
22 Nov 2017
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Latest Key Developments (Source: Significant Developments)

Spark Therapeutics reports Q3 loss per share $1.90
Tuesday, 7 Nov 2017 07:30am EST 

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 07:15am EST 

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 07:30am EDT 

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

Spark Therapeutics enters into licensing agreement with Genethon
Wednesday, 20 Sep 2017 07:30am EDT 

Sept 20 (Reuters) - Spark Therapeutics Inc :Spark Therapeutics enters into licensing agreement with Genethon.Spark Therapeutics Inc - ‍specific genetic target and financial terms of agreement have not been disclosed​.Spark Therapeutics Inc -co ‍ has option to develop and commercialize any gene therapy that results from licensing agreement​.Spark Therapeutics Inc - under terms of agreement, Genethon will collaborate with Spark Therapeutics on further preclinical research activities.  Full Article

Spark Therapeutics announces proposed public offering of common stock
Wednesday, 2 Aug 2017 05:04pm EDT 

Aug 2 (Reuters) - Spark Therapeutics Inc ::Spark Therapeutics announces proposed public offering of common stock.Spark Therapeutics Inc - ‍commenced an underwritten public offering of $300 million in shares of its common stock​.  Full Article

Spark Therapeutics posts Q2 loss per share of $2.40
Wednesday, 2 Aug 2017 07:30am EDT 

Aug 2 (Reuters) - Spark Therapeutics Inc ::Spark therapeutics reports second quarter 2017 financial results and recent business progress.Q2 loss per share $2.40.Q2 earnings per share view $-1.72 -- Thomson Reuters I/B/E/S.Spark therapeutics inc - recognized $1.5 million of revenue associated with Pfizer collaboration in quarter.Spark therapeutics inc - during three months ended June 30, 2017, recorded a non-cash impairment charge of $15.7 million.Spark therapeutics inc - as of June 30, 2017, had cash and cash equivalents and marketable securities of $238.6 million, with 31.2 million shares outstanding.Spark therapeutics - also disclosed preliminary initial data from phase 1/2 dose-escalation clinical trial for spk-8011.Spk-8011 is being investigated as a potential one-time therapy for Hemophilia A.Spark therapeutics - with 3 participants infused in hemophilia a dose-escalation clinical trial, there have been no serious adverse events reported to date.  Full Article

Spark Therapeutics submits marketing authorization application to European medicines agency for investigational luxturna (voretigene neparvovec)
Monday, 31 Jul 2017 07:30am EDT 

July 31 (Reuters) - Spark Therapeutics Inc :Spark therapeutics submits marketing authorization application to European medicines agency for investigational luxturna (voretigene neparvovec).Spark Therapeutics-‍investigational therapy is under priority review with U.S. FDA, with assigned prescription drug user fee act date of Jan 12, 2018​.  Full Article

Spark Therapeutics gets rare pediatric disease designation for its investigational treatment from FDA
Thursday, 20 Jul 2017 07:30am EDT 

July 20 (Reuters) - Spark Therapeutics Inc :Spark Therapeutics receives rare pediatric disease designation for investigational LUXTURNA (voretigene neparvovec) from FDA.Spark Therapeutics Inc- ‍Prescription Drug User Fee Act (PDUFA) action date of Jan 12, 2018 for LUXTURNA​.  Full Article

FDA accepts Spark Therapeutics's application to review Luxturna
Monday, 17 Jul 2017 07:30am EDT 

July 17 (Reuters) - Spark Therapeutics Inc -:Spark Therapeutics’ biologics license application for investigational voretigene neparvovec accepted for filing by FDA.Says for review of Luxturna, FDA has assigned a PDUFA date of Jan. 12, 2018.Says Luxturna (voretigene neparvovec) unveiled as proposed trade name.  Full Article

Selecta Biosciences notifies Spark Therapeutics about license agreement
Friday, 9 Jun 2017 05:37pm EDT 

June 9 (Reuters) - Spark Therapeutics Inc ::Selecta Biosciences-on june 5,notified Spark Therapeutics, license agreement would terminate as Spark had not made may 2017 license payment by may 31.  Full Article

BRIEF-Spark Therapeutics and Pfizer amend license agreement for investigational SPK-9001 in hemophilia B

* Spark Therapeutics and Pfizer amend license agreement for investigational SPK-9001 in hemophilia B