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AI brief of an SEC Form 8-K · Aquestive Therapeutics, Inc. (AQST)

Aquestive says FDA accepted Anaphylm resubmission, sets March 16, 2027 PDUFA date

Positive Impact 4 of 5 legal/regulatory Written later

Aquestive Therapeutics said the FDA has accepted its resubmitted New Drug Application for Anaphylm as complete and classified it as a Class 2 response, with a PDUFA goal action date of March 16, 2027. The filing does not provide financial figures, and the outcome depends on the FDA's review, which the company says it expects to complete on or before the goal date.

Key points

  • FDA acknowledged the Anaphylm NDA resubmission as complete and classified it as a Class 2 response
  • PDUFA goal action date set for March 16, 2027
  • Aquestive submitted the resubmission on September 16, 2026, after a January 30, 2026 Complete Response Letter
  • Ex-U.S. submission to Health Canada remains on track for Q4 2026

The filing

CompanyAquestive Therapeutics, Inc. (AQST)
Form8-K, current report
Filed with the SECOct 15, 2026, 7:21 AM ET
Accession number0001398733-26-000058

Items reported: 7.01 Regulation FD Disclosure

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 15, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.