Disc Medicine Says FDA Engagement Over Bitopertin Remains Productive -- Market Talk

Dow Jones

01/14

1416 ET - Disc Medicine management maintained that their engagement with the FDA about approval for bitopertin remains constructive in an analyst event at the JPMorgan Healthcare Conference, BMO says in a note. The company is looking to dispel investor jitters about an article in STAT News reporting that Center for Biologics Evaluation and Research Director Vinay Prasad is skeptical about the bitopertin application. "Disc's management highlighted specifically (and again) that interaction with FDA remains productive and consistent with the company and FDA reviewers communicating frequently without mention of any alleged concerns from Prasad as it relates to bitopertin's submission," analysts writes, adding that BMO was impressed by Disc's commercial preparation for the drug.(elias.schisgall@wsj.com)

(END) Dow Jones Newswires

January 13, 2026 14:16 ET (19:16 GMT)

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The company is looking to dispel investor jitters about an article in STAT News reporting that Center for Biologics Evaluation and Research Director Vinay Prasad is skeptical about the bitopertin application. \"Disc's management highlighted specifically (and again) that interaction with FDA remains productive and consistent with the company and FDA reviewers communicating frequently without mention of any alleged concerns from Prasad as it relates to bitopertin's submission,\" analysts writes, adding that BMO was impressed by Disc's commercial preparation for the drug.(elias.schisgall@wsj.com) \n\n\n  (END) Dow Jones Newswires\n\n\n  January 13, 2026 14:16 ET (19:16 GMT)\n\n\n  Copyright (c) 2026 Dow Jones & Company, Inc.","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":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}