FDA Grants Priority Review to Disc Medicine’s Bitopertin NDA

Reuters

Jan 12

FDA Grants Priority Review to <a href="https://laohu8.com/S/IRON">Disc Medicine</a>’s Bitopertin NDA

Disc Medicine Inc. announced that its New Drug Application (NDA) for bitopertin has been submitted and accepted under the accelerated approval pathway with priority review by the U.S. Food and Drug Administration (FDA). Bitopertin was awarded the Commissioner's National Priority Voucher (CNPV), a pilot program designed to accelerate the NDA review period to 1-2 months. The NDA is currently under FDA review. No other organizations were mentioned as beneficiaries in this announcement.

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. Disc Medicine Inc. i published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-26-009871), on January 12, 2026, and is solely responsible for the information contained therein.

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ID: 0001193125-26-009871), on January 12, 2026, and is solely responsible for the information contained therein.</span></i>\n</p>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IRON","symbol_name":"Disc Medicine","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260112:nNDL2JgGM8:1","article_id":"2602470548","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2602470548","pubTimestamp":1768225072,"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":"Disc Medicine Inc. announced that its New Drug Application  for bitopertin has been submitted and accepted under the accelerated approval pathway with priority review by the U.S. Food and Drug Administration . Bitopertin was awarded the Commissioner's National Priority Voucher , a pilot program designed to accelerate the NDA review period to 1-2 months. The NDA is currently under FDA review. No other organizations were mentioned as beneficiaries in this announcement.Disclaimer: This news brief was created by Public Technologies  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. 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ID: 0001193125-26-009871), on January 12, 2026, and is solely responsible for the information contained therein.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}