Will the FDA approve Pharvaris's deucrictibant for on-demand treatment of hereditary angioedema attacks by May 7, 2027?
deadline 2027-05-07
confidence medium
tier 4 evidence
89%PolySignal estimate
Resolution criterion
Yes if the FDA approves deucrictibant for the indication stated above (Drugs@FDA entry, FDA announcement or Pharvaris press release) no later than May 7, 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 9, 2026: according to the Pharvaris filing of August 5, 2026, the FDA has set a PDUFA target action date of April 23, 2027. Source: https://www.sec.gov/Archives/edgar/data/1802768/000180276826000014/rprx-20260630rpplcpressxre.htm
What pushes it up
- FDA has set a PDUFA target action date of April 23, 2027, which is before the May 7, 2027 deadline [1]
What pushes it down
- Only tier‑4 press reports note FDA acceptance of the NDA, which are weak signals and do not guarantee approval [4]
- Potential for a PDUFA extension or a complete response letter could push a decision past the deadline
What would move this number most
Whether the FDA will keep the April 23, 2027 PDUFA date or issue an extension/complete response letter
How this number is built
| Deadline | 2027-05-07 |
| Base rate | 87% |
| Best evidence | tier 4 · 1 article(s) used |
| Independent runs | 89 · 89 (spread 0 pts) |
| Confidence | medium |
| Evidence cap | not triggered |
| Last revised | 2026-10-09 21:31 |
| Model | openai/gpt-oss-120b (Groq) |
Sources consulted