Aquestive Therapeutics (AQST) catalysts

Upcoming FDA decisions and readouts we track for Aquestive Therapeutics, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 24 Oct 2026

FreeBioList tracks 1 upcoming catalyst for Aquestive Therapeutics (AQST, listed on Nasdaq). It concerns Anaphylm (dibutepinephrine) sublingual film (Type I allergic reactions including anaphylaxis).

First on the list: the PDUFA date for Anaphylm (dibutepinephrine) sublingual film (Type I allergic reactions including anaphylaxis), dated 16 Mar 2027.

The row links to an SEC filing (8-K or 6-K). It has been verified by a person reading the filing itself, most recently on 24 Oct 2026. The methodology page explains each status.

Background reading: What a PDUFA date is, and why the FDA doesn't publish them.

Ticker: AQST
Next catalyst: 16 Mar 2027
Type: PDUFA date
Listed options: Not yet checked

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Aquestive Therapeutics AQST · Nasdaq	Anaphylm (dibutepinephrine) sublingual film	Type I allergic reactions including anaphylaxis	16 Mar 2027 in 141d	PDUFA date	Verified	8-K exhibit 99.1 ↗	—
Notes — Filing states the FDA accepted the resubmission "as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027, in keeping with the FDA's classification of the resubmission as a Class 2 response." Source: 8-K exhibit 99.1, filed 15 Oct 2026 · verified 24 Oct 2026

Also due in Q1 2027

Intellia Therapeutics (NTLA)PDUFA date for Lonvoguran ziclumeran (lonvo-z), 10 Mar 2027
Unicycive Therapeutics (UNCY)PDUFA date for Oxylanthanum carbonate (OLC), Mar 2027 (expected)
Cullinan Therapeutics (CGEM)PDUFA date for Zipalertinib, 27 Feb 2027
ImmunityBio (IBRX)PDUFA date for ANKTIVA (nogapendekin alfa) plus BCG, 06 Jan 2027
Apnimed (APMD)PDUFA date for AD109 (Oxnimbi), 28 Feb 2027
Biohaven (BHVN)PDUFA date for Vyglxia (troriluzole), Q1 2027