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Spark Therapeutics, Inc. (ONCE) Create: Alert

All | News | Filings
Date FiledTypeDescription
11/06/2018 8-K Quarterly results
Docs: "Spark Therapeutics Reports Third Quarter 2018 Financial Results and Recent Business Progress PHILADELPHIA, Nov. 6, 2018 - Spark Therapeutics , a fully integrated, commercial gene therapy company dedicated to challenging the inevitability of genetic disease, announced today corporate and financial results for the third quarter of 2018 and recent business progress. “In the third quarter, we made significant progress with LUXTURNA both in terms of sales growth and medical policy coverage expansion. We have also made important advancements in preparing for the Phase 3 run-in study of investigational SPK-8011 for hemophilia A before year end,” said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. “Additionally, we continue to capitalize on our proven and proprietary adeno-ass..."
08/07/2018 8-K Quarterly results
Docs: "Spark Therapeutics Reports Second Quarter 2018 Financial Results and Recent Business Progress As of July 13, 2018, preliminary Phase 1/2 data for investigational SPK-8011 for hemophilia A show:"
05/08/2018 8-K Quarterly results
Docs: "Spark Therapeutics Reports First Quarter 2018 Financial Results and Recent Business Progress Achieved historic milestone with first patients treated with LUXTURNA™ PHILADELPHIA, May 8, 2018 - Spark Therapeutics , a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today corporate and financial results for the first quarter of 2018 and recent business progress. “We are encouraged by the initial launch of LUXTURNA™ . We are pleased that three patients were treated with LUXTURNA in the first quarter as we remain focused on working closely with treatment centers and payers to support timely access to the product,” said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. “Additionally, we progressed our pip..."
11/07/2017 8-K Quarterly results
Docs: "Spark Therapeutics Reports Third Quarter 2017 Financial Results and Recent Business Progress PHILADELPHIA, Nov. 7, 2017 - Spark Therapeutics , a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today financial results for the third quarter of 2017 and recent business progress. “We have made important progress over the last several months with investigational LUXTURNA™ for patients with biallelic RPE65-mediated inherited retinal disease ,” said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. “We are very pleased with the outcome of the Advisory Committee meeting, including the unanimous vote to recommend approval of LUXTURNA, with the completion of FDA pre-approval inspections of our manufacturing facili..."
08/02/2017 8-K Quarterly results
Docs: "Spark Therapeutics Reports Second Quarter 2017 Financial Results and Recent Business Progress Preliminary interim data for SPK-8011 Phase 1/2 dose-escalation clinical trial in hemophilia A show initial human proof-of-concept in three participants In the two participants at the initial dose, stable factor VIII levels average greater than 12 percent with no spontaneous bleeds Investigational LUXTURNA TM Prescription Drug User Fee Act date set for Jan. 12, 2018; granted rare pediatric disease designation by FDA PHILADELPHIA, Aug. 2, 2017 - Spark Therapeutics , a fully integrated gene therapy company dedicated to challenging the inevitability of genetic disease, announced today financial results for the second quarter of 2017 and recent business progress. “This has been an unprecedented time a..."
05/09/2017 8-K Form 8-K - Current report
11/03/2016 8-K Form 8-K - Current report
08/10/2016 8-K Quarterly results
Docs: "Spark Therapeutics Reports Second Quarter 2016 Financial Results and Recent Business Highlights Updated timing of the completed BLA submission for voretigene neparvovec Earlier today, released additional positive data from the pivotal Phase 3 trial of voretigene neparvovec Reported positive preliminary safety and efficacy from the Phase 1/2 clinical trial of SPK-9001 in hemophilia",
"Spark Therapeutics Announces New Positive Data from Continuation of Phase 3 Trial of Voretigene Neparvovec Of the nine crossover subjects, eight responders demonstrated the maximum improvement measurable on the primary endpoint at one year 27 of 29, or 93%, of Phase 3 subjects that received voretigene neparvovec demonstrated a gain in functional vision at one year Follow-up data show two-year durability of benefit in the Phase 3 intervention group"
05/04/2016 8-K Form 8-K - Current report
03/09/2016 8-K Form 8-K - Current report
11/04/2015 8-K Quarterly results
Docs: "Spark Therapeutics Reports Third Quarter 2015 Financial Results and Recent Business Highlights Reported positive top-line results from pivotal Phase 3 trial of SPK-RPE65 for genetic blinding conditions Durability of effect of SPK-RPE65 reported at three years with observation ongoing Continued progression and expansion of pipeline and operations"
08/05/2015 8-K Quarterly results
Docs: "Spark Therapeutics Reports Second Quarter 2015 Results Confirming guidance for Phase 3 data readout for SPK-RPE65 in 2015; pipeline advancing and expanding"
05/06/2015 8-K Quarterly results
Docs: "Spark Therapeutics Reports First Quarter 2015 Results"
03/23/2015 8-K Quarterly results
Docs: "Spark Therapeutics Reports Full Year 2014 Financial Results"

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