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Fly News Breaks for October 17, 2016
SRPT, PTCT, BMRN
Oct 17, 2016 | 09:08 EDT
Janney Capital noted that PTC Therapeutics' (PTCT) Translarna and Sarepta's (SRPT) Exondys 51 address non-overlapping DMD populations and there was an expectation of flexibility from the FDA following the conditional approval of Exondys 51. However, the FDA has denied the first appeal of the refuse to file letter regarding PTC's NDA for Translarna for the treatment of nonsense mutation DMD, which the firm said has potential negative read-through for BioMarin's (BMRN) attempt to rekindle Kyndrisa, which is a direct competitor to Sarepta's Exondys 51. The firm added that the news might positively impact reimbursement decisions for Exondys 51.
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