Will the FDA approve Aquestive Therapeutics's dibutepinephrine (Anaphylm) for treatment of Type I allergic reactions, including anaphylaxis by March 30, 2027?
deadline 2027-03-30
confidence medium
tier 4 evidence
81%PolySignal estimate
Resolution criterion
Yes if the FDA approves dibutepinephrine for the indication stated above (Drugs@FDA entry, FDA announcement or Aquestive Therapeutics press release) no later than March 30, 2027. A complete response letter, an extension of the PDUFA date or the absence of a decision by then counts as no. An accelerated or conditional approval counts as an approval; a later label update does not change the outcome.
Verified starting state
As of October 16, 2026: according to the Aquestive Therapeutics filing of October 15, 2026, the FDA has set a PDUFA target action date of March 16, 2027. Source: https://www.sec.gov/Archives/edgar/data/1398733/000139873326000058/a2026-10x19aquestivepduf.htm
What pushes it up
- FDA set a PDUFA target action date of March 16, 2027, indicating a decision expected before the March 30 deadline [tier 1]
What pushes it down
- Previous Complete Response Letter and need to address usability and PK concerns suggest regulatory hurdles [tier 4]
- Only tier 4 press reports of resubmission; lack of higher-tier confirmation adds uncertainty [tier 4]
What would move this number most
Whether the FDA will meet the PDUFA target date without granting an extension or issuing another CRL.
How this number is built
| Deadline | 2027-03-30 |
| Base rate | 87% |
| Best evidence | tier 4 · 3 article(s) used |
| Independent runs | 79 · 82 (spread 3 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-16 15:39 |
| Model | openai/gpt-oss-120b (Groq) |
Sources consulted