Get 40% Off
🚀 AI-picked stocks soar in May. PRFT is +55%—in just 16 days! Don’t miss June’s top picks.Unlock full list

FDA action date today for PTC Therapeutics' "filing over protest" NDA for DMD med Translarna; shares down 5%

Published 10/24/2017, 03:36 PM
© Reuters.  FDA action date today for PTC Therapeutics' "filing over protest" NDA for DMD med Translarna; shares down 5%
SRPT
-
PTCT
-
  • 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


Original article

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.
© 2007-2024 - Fusion Media Limited. All Rights Reserved.