Biopharma Transcript

Aquestive Therapeutics, Inc. AQST

Nasdaq · Phase 3 · immunology/inflammation · small molecule · EDGAR · Updated Nov 5, 2026

Aquestive Therapeutics, Inc. (Nasdaq: AQST) is an immunology/inflammation drug developer. Its lead program, Anaphylm (dibutepinephrine) sublingual film, is in Phase 3 for Type 1 allergic reactions, including anaphylaxis. Its next catalyst on record is Libervant: PDUFA goal date for patients twelve years of age and older (March 2027).

Upcoming catalysts

  1. March 2027
    Libervant — PDUFA goal date for patients twelve years of age and olderFinal FDA approval for patients twelve years of age and older is subject to expiration of the orphan drug exclusivity for Valtoco® on January 10, 2027, and final FDA action, with a PDUFA goal date of March 23, 2027.

Next further out: Anaphylm — Regulatory application submission to Health Canada (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.

Pipeline

ProgramIndicationModalityStage
Anaphylm (dibutepinephrine) sublingual filmType 1 allergic reactions, including anaphylaxissmall moleculePhase 3
Libervant (diazepam) buccal filmAcute treatment of intermittent, stereotypic episodes of frequent seizure activity (seizure clusters) in patients with epilepsysmall moleculePhase 3
AQST-108 (epinephrine) topical gelAtopic dermatitis and other dermatologic indicationssmall moleculePhase 1

Recent results and decisions

  1. Sep 17, 2026
    submitted Aquestive resubmitted the Anaphylm NDA to FDA following the January 2026 CRL; FDA will set classification and review timeline.FDA will determine the resubmission classification and establish the applicable review timeline following its initial review of the resubmission Filing
  2. Sep 16, 2026
    accepted Anaphylm NDA resubmission accepted by FDA as Class 2 response with PDUFA goal date of March 16, 2027.On September 16, 2026, the Company resubmitted its New Drug Application (NDA) for Anaphylm to the U.S. Food and Drug Administration (FDA). The FDA acknowledged the resubmission as complete, classified it as a Class 2 response and assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 1 Filing
  3. Aug 11, 2026
    positive Aquestive completed the human factors validation study and pharmacokinetic study for Anaphylm requested in the CRL; no numeric results given in this release.Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film Filing

2 more on record.

For subscribers

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