Aquestive Therapeutics, Inc. AQST
Aquestive Therapeutics, Inc. (Nasdaq: AQST) is an immunology/inflammation drug developer. Its lead program, Anaphylm (dibutepinephrine) sublingual film, is in Phase 3 for Severe allergic reactions including anaphylaxis. Its next catalyst on record is AQST-108: Additional preclinical and clinical studies (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: AQST-108 — Additional preclinical and clinical studies (H2 2026). 4 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Anaphylm (dibutepinephrine) sublingual film | Anaphylaxis / severe allergic reactions | small molecule | Phase 3 |
| Libervant (diazepam) buccal film | Seizure clusters, ages 2-5 (approval converted to tentative after court ruling); ages 6-11 filing made Q2 2026 | small molecule | Phase 3 |
| AQST-108 (epinephrine) topical gel | Alopecia areata; atopic dermatitis | small molecule | Phase 1 |
Recent results and decisions
- Sep 17, 2026submitted 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 - Aug 11, 2026positive 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 - May 13, 2026positive Completed Phase 1 study of AQST-108 in subjects with androgenic alopecia with no safety issues observed.
Completed AQST-108 phase 1 study in subjects with androgenic alopecia with no safety issues observed
Filing
2 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.