On Thursday afternoon, and FDA advisory panel recommended approval of Spark Therapeutics Inc ONCE 0.68%’s Luxturna treatment for inherited blindness. A number of Wall Street analysts weighed in on the stock following the news.
Here’s an overview of what they had to say.
Voices From The Street
Bernstein analyst Vincent Chen said the ruling was good news for gene therapy treatments as a whole. “Our sense is that the FDA came into the meeting wanting to approve the drug,” Chen wrote.
BMO Capital Markets analyst Matthew Luchini said investors should expect FDA approval for Luxturna by its January 12 PDUFA. “We believe investor attention will likely shift to commercial execution, especially related to pricing and reimbursement as Luxturna is poised to be the first FDA-approved gene therapy,” Luchini wrote.
Jefferies analyst Michael Yee said approval and uptake may take some time due to the disease’s rarity. “Patient testimonies were heartwarming while panel discussions were productive and supportive of Luxturna’s U.S. approval, in our view,” Yee wrote.
Chardan analyst Gbola Amusa said Luxturna could be a groundbreaking treatment if approved. “After the unanimous backing of the panel, Luxturna, which has a PDUFA date of 12 January 2018, could achieve a number of firsts if approved, i.e. by becoming: 1) the first gene therapy approved in the US for a genetic disease, 2) the first in vivo and AAV-based gene therapy approved in the US, and 3) the first pharmacologic treatment approved for an inherited retinal disease,” Amusa wrote.
Cantor Fitzgerald analyst Elemer Piros has raised his probability of commercial success for Luxturna from 95 percent to 100 percent. “Following expectations of a single payment structure, we model for a single $1 million payment per patient and approximately 150 patients treated within the first two years of launch,” Piros wrote.
UBS analyst Carter Gold said the two remaining unknowns are the lower age limit for treatments and whether or not repeat doses will be needed. “We don’t see either of these concerns negatively impacting the drug’s perceived implied valuation,” Gold wrote.
Ratings And Price Targets
Following the news, most of Wall Street is…
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