Aquestive Therapeutics Shares Rise, FDA Forgos Meeting on Anaphylm

Dow Jones

Sep 05

By Dean Seal

Shares of Aquestive Therapeutics climbed after the company said federal regulators wouldn't require an advisory committee meeting for its anaphylaxis treatment Anaphylm.

The stock was up 20% at $4.74 on Thursday. Shares have gained 33% since the start of the year.

The Food and Drug Administration has informed Aquestive that an advisory committee meeting, which tends to slow the agency's approval process, wouldn't be required for Anaphylm to get approved, the pharmaceutical company said.

Aquestive's new drug application for Anaphylm remains on track for an FDA approval target date of Jan. 31, the company said.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

September 04, 2025 12:17 ET (16:17 GMT)

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Shares have gained 33% since the start of the year. \n\n\n  The Food and Drug Administration has informed Aquestive that an advisory committee meeting, which tends to slow the agency's approval process, wouldn't be required for Anaphylm to get approved, the pharmaceutical company said. \n\n\n  Aquestive's new drug application for Anaphylm remains on track for an FDA approval target date of Jan. 31, the company said. \n\n\n \n\n\n  Write to Dean Seal at dean.seal@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  September 04, 2025 12:17 ET (16:17 GMT)\n\n\n  Copyright (c) 2025 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"}}}