Name in SEC filings: Aquestive Therapeutics, Inc.
Source: ORION, orionbiotechai.com/company/AQST, data as of Oct 17, 2026
https://www.orionbiotechai.com/company/AQST
Anaphylm · NDA/BLA submission · for Q4 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
NDA/BLA submissionfor Q4 2026
Stage: —
Public float: $291,600,000 · as of · SEC filing
Ex-U.S. strategy remains on track with Canadian NDS planned for Q4 2026
SEC timing context:
Aquestive Therapeutics Announces FDA Acceptance of Anaphylm™ NDA Resubmission and PDUFA Goal Date of March 16, 2027
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
PDUFA target date (company stated)March 16, 2027
Stage: PDUFASEC filing · “PDUFA) goal date”
Public float: $291,600,000 · as of · SEC filing
On October 15, 2026, Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-03)
NDA/BLA submissionin 2027
Stage: —
Public float: $291,600,000 · as of · SEC filing
The Company expects to file its New Drug Submission in Canada in 2026 and the EU in 2027.
SEC timing context:
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.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| AnaphylmSubmission | for Q4 2026“Ex-U.S. strategy remains on track with Canadian NDS planned for Q4 2026” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| AnaphylmFDA decision | March 16, 2027“On October 15, 2026, Aquestive Therapeutics, Inc. ("Aquestive" or the "Company") issued a press release announcing that the U.S. Food and Drug Administration (FDA) has acknowledged its resubmission of the New Drug Application (NDA) for Anaphylm™ (dibutepinephrine) sublingual film for the treatment of Type I allergic reactions, including anaphylaxis, as complete and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 16, 2027.” Filed · 8-K | Period not started The stated period has not started yet, so there is nothing to compare. |
| AnaphylmSubmission | in 2027“The Company expects to file its New Drug Submission in Canada in 2026 and the EU in 2027.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
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