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

PTC Therapeutics to dispute FDA response letter on ataluren

Published 10/25/2017, 12:40 PM
© Reuters.  PTC Therapeutics to dispute FDA response letter on ataluren
PTCT
-
  • PTC Therapeutics (PTCT +4.3%) announces it received a complete response letter from the FDA for its new drug application of the investigational medicine ataluren for the treatment of nonsense mutation dystrophinopathies. The letter indicated that evidence of effectiveness from an additional adequate and well-controlled clinical trial will be needed to provide evidence of effectiveness.
  • The company believes that the decision fails to consider the benefit-risk of ataluren and the "high unmet" medical need. The company plans to file a formal dispute resolution request next week.
  • Shares of PTCT are higher after coming off a trading halt.
  • Source: Press Release
  • Now read: Roche: Buying The Dip


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.