October 25, 2017
FDA action date today for PTC Therapeutics’ “filing over protest” NDA for DMD med Translarna; shares down 5%
© Reuters. FDA action date today for PTC Therapeutics’ “filing over protest” NDA for DMD med Translarna; shares down 5%
- Investors are sending a clear signal that they do not expect good news today from the FDA regarding PTC Therapeutics’ (PTCT -4.6%) New Drug Application (NDA) seeking approval for Translarna (ataluren) for the treatment of Duchenne muscular dystrophy (DMD). Today is the agency’s action date under “filing under protest” regulations. Last month, an advisory committee voted 10 – 1 that the efficacy data supporting the application was inconclusive.
- Shares have sold off more than 22% this month.
- Sarepta Therapeutics (SRPT -4.7%), maker of DMD med EXONDYS 51 (eteplirsen), is also under pressure ahead of tomorrow’s Q3 earnings report.
- Previously: FDA to review PTC’s marketing application for DMD candidate Translarna under protest regulations; action date October 24; shares ahead 15% premarket (March 6)
- Previously: FDA Ad Com says data on PTC’s Translarna inclusive, more needed to prove efficacy (Sept. 28)
- Now read: Your Daily Pharma Scoop: Nektar’s Potential, Axovant Finally Fails, PTCT AdComm Tomorrow