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ONCE

Spark Therapeutics

$71.33

1.04 (1.48%)

07:32
07/31/17
07/31
07:32
07/31/17
07:32

Spark Therapeutics submits MAA to EMA for Luxturna

Spark Therapeutics announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for Luxturna, the proposed trade name for voretigene neparvovec, an investigational, one-time gene therapy for the treatment of patients with vision loss due to Leber congenital amaurosis or retinitis pigmentosa caused by confirmed biallelic RPE65 mutations. The MAA includes data from three clinical trials that enrolled 41 participants with RPE65-mediated inherited retinal dystrophy, including the first randomized, controlled Phase 3 trial for a gene therapy for a genetic disease. Once EMA has validated the application, the review period will begin. Spark Therapeutics has previously received orphan product designations for Luxturna from EMA for the treatment of both Leber congenital amaurosis and retinitis pigmentosa.

  • 02

    Aug

  • 12

    Jan

ONCE Spark Therapeutics
$71.33

1.04 (1.48%)

07/27/17
BERN
07/27/17
INITIATION
BERN
Outperform
Spark Therapeutics initiated with an Outperform at Bernstein
Bernstein analyst Vincent Chen started coverage of Spark with an $87 price target and an Outperform rating. The analyst says that Spark's hemophilia gene therapy, SPK-8011, should generate "decent data" and is being underestimated by the market. He says that there is room for the therapy to positively differentiate from Biomarin's (BMN) BMN 270.
07/11/17
JEFF
07/11/17
NO CHANGE
JEFF
Jefferies fundamentally positive on Biotechnology, lists top picks
Jefferies analyst Michael Yee rolled out coverage of 12 Biotechnology names in a 550 page research report. The analyst is "fundamentally positive" on the sector, believing investor interest in large-caps will pick up "as the road to repair slowly continues." He believes the smid-cap space is "becoming a good stock-pickers' market." Yee's top picks in Biotech space include Celgene (CELG), Vertex (VRTX), Spark Therapeutics (ONCE), Prothena (PRTA) and Intercept (ICPT). The analyst's best picks in the smid-cap space are Spark, Prothena, Intercept and FibroGen (FGEN).
07/10/17
JEFF
07/10/17
INITIATION
Target $85
JEFF
Buy
Spark Therapeutics initiated with a Buy at Jefferies
Jefferies analyst Michael Yee initiated Spark Therapeutics with a Buy and an $85 price target.
06/29/17
RHCO
06/29/17
NO CHANGE
RHCO
Expert upbeat on Spark Therapeutics hemophilia drug, says SunTrust
After speaking with a hemophilia expert, SunTrust analyst Edward Nash reports that the expert is upbeat on Spark's hemopihlia treatment, SPK-9001. Specifically, the expert says that the drug achieves "high FIX levels using a low dose," Nash reported. The expert adds that he does not believe that the drug's use of Padua raises any safety concerns, noted Nash. The analyst says that " SPK-9001 appears to be the most promising gene therapy program for the treatment of hemophilia B." He keeps a Buy rating on Spark.

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, ESV

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