PTC Therapeutics, Inc. PTCT 4.79% shares are up another 4.2 percent in early Tuesday trading following a big 20.6 percent Monday gain. The big move in PTC shares has been driven by the FDA’s accelerated approval of Sarepta Therapeutics Inc SRPT 8.45%’s Eteplirsen for treatment of exon 51 skipping amenable Duchenne’s muscular dystrophy.
The market seems to take the FDA approval of Eteplirsen as a positive sign for PTC’s own Duchenne’s muscular dystrophy drug, Ataluren. However, Jefferies analyst Gena Wang is not convinced. According to Wang, the FDA approval of Eteplirsen was based on a key piece of data that Ataluren’s Phase III trial is lacking.
Key Difference Between PTC And Sarepta’s Muscular Dystrophy Rx
“Although PTCT’s ataluren is considered safe, the FDA approval of eteplirsen is mainly based on the marginal increase of dystrophin level while PTCT does not have any dystrophin data from PH3,” Wang explained.
Back in Q2, PTC submitted an appeal of the FDA’s Refuse to File letter regarding Ataluren. While Wang believes that approval of Eteplirsen could pressure the FDA to review the appeal in the near future, she doesn’t believe…
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