PTC Therapeutics Receives FDA Approval for SEPHIENCE™ to Treat Phenylketonuria; European Commission Grants Marketing Authorization

Reuters

07-29

PTC <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Receives FDA Approval for SEPHIENCE™ to Treat Phenylketonuria; European Commission Grants Marketing Authorization

PTC Therapeutics Inc. has announced that their drug SEPHIENCE™ (sepiapterin) has received marketing authorization from the European Commission. This approval allows PTC Therapeutics to bring their treatment to children and adults with phenylketonuria (PKU) across Europe. The approval follows significant efficacy and safety results from the Phase 3 APHENITY trial and its long-term extension study. Additionally, regulatory review processes are ongoing in several other countries, including Japan and Brazil, reflecting the global reach and potential impact of SEPHIENCE in addressing the unmet needs of the PKU community.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. PTC Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NY39113) on July 28, 2025, and is solely responsible for the information contained therein.

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PTC Therapeutics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: NY39113) on July 28, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU0320765992.SGD","symbol_name":"FTIF - Franklin Biotechnology Discovery A Acc SGD","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250728:nNDL3lFJZd:1","article_id":"2555870130","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2555870130","pubTimestamp":1753733958,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"PTC Therapeutics Receives FDA Approval for SEPHIENCE to Treat Phenylketonuria; European Commission Grants Marketing Authorization. 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