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ONCE

Spark Therapeutics

07:40
07/17/17
07/17
07:40
07/17/17
07:40

Spark: FDA accepts BLA, grants Priority Review to voretigene neparvovec

Spark Therapeutics announced that the FDA has accepted for filing the Biologics License Application, or BLA, and granted Priority Review for voretigene neparvovec, an investigational, potential one-time gene therapy candidate for the treatment of patients with vision loss due to confirmed biallelic RPE65-mediated inherited retinal disease, or IRD. The investigational gene therapy, which has the proposed trade name LUXTURNA, has the potential to be both the first pharmacologic treatment for IRD and the first gene therapy for a genetic disease in the United States. Priority Review is granted to therapeutics that would offer major advances over existing therapies or would provide a treatment where no adequate therapy exists. FDA's goal for taking an action on Priority Review applications is six months. For the review of LUXTURNA, FDA has assigned a PDUFA date of Jan. 12, 2018.

ONCE Spark Therapeutics

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.
06/28/17
WBLR
06/28/17
INITIATION
WBLR
Outperform
Spark Therapeutics initiated with an Outperform at William Blair
William Blair analyst Raju Prasad started Spark Therapeutics with an Outperform rating saying the company is a leader in gene therapy.
05/10/17
LEER
05/10/17
NO CHANGE
Target $79
LEER
Outperform
Spark Therapeutics price target lowered to $79 from $85 at Leerink
Leerink analyst Joseph Schwartz lowered his price target for Spark Therapeutics to $79 from $85 on decreased probability of success for SPK-7001 pending future updates. The analyst reiterates an Outperform rating on the shares.
03/30/17
03/30/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Sunoco (SUN) initiated with a Sell at Goldman. 2. CyberArk (CYBR) initiated with an Equal Weight at Morgan Stanley. 3. Humana (HUM) reinstated with an Outperform at Oppenheimer. 4. Qualys (QLYS) initiated with an Overweight at Morgan Stanley. 5. Alexion (ALXN), AveXis (AVXS), and Spark Therapeutics (ONCE) were initiated with a Buy at UBS, while Alnylam (ALNY) and BioMarin (BMRN) were initiated with a Neutral, and United Therapeutics (UTHR) was initiated with a Sell. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.

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NEWS

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James River Group

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MDB

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NFLX

Netflix

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PSX

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VZ

Verizon

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VLO

Valero

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SNDX

Syndax

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IMDZ

Immune Design

$10.10

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CVS

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IPXL

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ANDV

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TCMD

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AGN

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GRPN

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Initiation
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FANG

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UNFI

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GM

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