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Spark Therapeutics: Inside The Dramatic FDA AdCom Meeting

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Spark Therapeutics: Inside The Dramatic FDA AdCom Meeting
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Analysts at Cantor Fitzgerald continue to hold a bullish stance on Spark Therapeutics Inc (NASDAQ: ONCE) after the U.S. Food and Drug Administration gave the company a critical recommendation for its therapy called Luxturna. Analyst Elemer Piros maintains an Overweight rating on Spark's stock with a price target raised from $94 to $105.

Luxturna, Spark's therapy for the treatment of biallelic RPE65 mutation-associated retinal dystrophy, voted by an FDA advisory committee panel 16-0 to recommend the drug's approval on Thursday, the analyst said. Luxturna is now one step closer to becoming the first ever approved gene therapy for the treatment of any genetic condition in the U.S.

Spark's therapy was able to show "unprecedented and impressive" reversal of the disease, Piros said. While one of the panelists did recommend a re-calibration of the multi-luminance mobility test's (MLMT) primary endpoint to become more meaningful, the overall conclusion was that "no better tools exist and that results were clinically meaningful."

Physicians and surgeons who took part in the FDA's discussion "reflected reassurance and comfort on the overall safety profile." Also, while Luxturna is intended for patients three years and older some members of the panel contemplated the possibility of dosing younger patients.

The analyst's probability of ultimate FDA approval for a launch has been boosted from 95 percent to 100 percent and a quick approval is now expected prior to Luxturna's PDUFA date, which is scheduled for Jan. 12, 2018.

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Latest Ratings for ONCE

DateFirmActionFromTo
Oct 2017BarclaysMaintainsOverweight
Oct 2017BMO CapitalMaintainsOutperform
Oct 2017Raymond JamesInitiates Coverage OnOutperform

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