Aquestive Therapeutics, Inc.
AQSTNext catalyst
Anaphylm (dibutepinephrine) sublingual film
Type I allergic reactions, including anaphylaxis
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Plus 2 more upcoming events in our data (NDA filing, PDUFA date).See the timeline
3 upcoming, 1 past
NDA Filing - Anaphylm
For anaphylaxis. Aquestive Therapeutics announced that the FDA accepted its NDA resubmission for Anaphylm and set a PDUFA goal date of March 16, 2027.
SourceFDA PDUFA Date Anaphylm (dibutepinephrine) sublingual film
For Type I allergic reactions, including anaphylaxis. NDA filing. Extracted from SEC filing: EX-99.1
SourceFDA PDUFA Date LIBERVANT (diazepam buccal film) (standard)
For Seizure clusters / acute repetitive seizures in patients with epilepsy, label expansion to ages 6 to 11. NDA filing. Extracted from SEC filing: EX-99.1
SourceUpcoming FDA decisions
How AQST's past catalysts played out
Market Overview
Stock performance and key metrics
Diazepam Buccal Soluble Film with individual dose determined according to age and weight category
Epilepsy
Diazepam Buccal Film
Epilepsy
Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
Epilepsy
DESF
Allergic Reaction
Epinephrine Injection
Allergic Reaction
| Drug Name | Phase | Indication | Designations | Patent |
|---|---|---|---|---|
Diazepam Buccal Soluble Film with individual dose determined according to age and weight category | Phase 3 | Epilepsy | - | - |
Diazepam Buccal Film | Phase 2 | Epilepsy | - | - |
Diastat® Rectal Gel (Valeant Pharmaceuticals USA) | Phase 2 | Epilepsy | - | - |
DESF | Phase 2 | Allergic Reaction | - | - |
Epinephrine Injection | Phase 2 | Allergic Reaction | - | - |
Frequently asked questions
What is in Aquestive Therapeutics, Inc.'s drug pipeline?→
CatalystAlert tracks 5 drug candidates in Aquestive Therapeutics, Inc.'s (AQST) pipeline across Phase 3, Phase 2. Its lead program is Diazepam Buccal Film (Phase 2). Each drug's phase, indication and upcoming catalysts are listed on this page.
When is Aquestive Therapeutics, Inc.'s next FDA catalyst?→
Aquestive Therapeutics, Inc.'s (AQST) next tracked catalyst is a PDUFA date expected Mar 16, 2027. See the catalyst timeline on this page for the full schedule of PDUFA dates, trial readouts and FDA events.
How do I track AQST biotech catalysts?→
Add AQST to your CatalystAlert watchlist for alerts ahead of each catalyst, and follow Aquestive Therapeutics, Inc.'s live catalyst calendar, drug pipeline and clinical-trial timeline on this page — sourced from ClinicalTrials.gov, FDA and SEC filings.