Anaphylm™ (epinephrine) — PDUFA
Q3 2026
Reaffirms guidance to resubmit Anaphylm™ (dibutepinephrine) sublingual film NDA in Q3 2026; Type A meeting with FDA expected to occur within 30 daysSource filing
AQST biotech catalysts & pipeline
AQUESTIVE THERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
Anaphylm™ (dibutepinephrine) — NDA/BLA submission
Q3 2026
The Company will include the HF and clinical PK data in its planned resubmission of the Anaphylm New Drug Application to the FDA, which the Company is expecting to complete in the third quarter of 2026.Source filing
Anaphylm™ (dibutepinephrine) — NDA/BLA submission
in Q4 2026
On track to begin ex-U.S. filings of Anaphylm in Q4 2026Source filing
Anaphylm™ (dibutepinephrine) — NDA/BLA submission
2027
The Company expects to file its New Drug Submission in Canada in 2026 and the EU in 2027.Source filing