# Imsidolimab PDUFA Event: Generalized pustular psoriasis

Canonical URL: https://biopharmsignal.com/pdufa-calendar/VNDA/imsidolimab-generalized-pustular-psoriasis

Ticker: VNDA

Company: Vanda Pharmaceuticals

Event date: 2026-12-12

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. FDA assigned a December 12, 2026 PDUFA target action date to the imsidolimab BLA.

## Event Timeline

### December 12, 2026 — FDA decision expected

FDA assigned a December 12, 2026 PDUFA target action date to the imsidolimab BLA.

[Vanda — BLA acceptance and target action date](https://vandapharmaceuticalsinc.gcs-web.com/node/16791/pdf)

### April 28, 2026 — Pivotal imsidolimab results were published

Results from the registration-enabling generalized pustular psoriasis clinical program were published in NEJM Evidence.

[Vanda — First-quarter update and pivotal publication](https://vandapharmaceuticalsinc.gcs-web.com/node/16971/pdf)

### February 25, 2026 — FDA accepted the BLA for review

FDA accepted Vanda's filing for imsidolimab in generalized pustular psoriasis and established the target action date.

[Vanda — BLA acceptance](https://vandapharmaceuticalsinc.gcs-web.com/node/16791/pdf)

### December 2025 — Vanda submitted the BLA

Vanda submitted the imsidolimab application after completing the registration-enabling GEMINI-1 and GEMINI-2 studies.

[Vanda — 2025 annual report and BLA submission](https://www.sec.gov/Archives/edgar/data/1347178/000162828026007460/vnda-20251231.htm)

### April 14, 2022 — Phase 3 GEMINI-1 started

The randomized Phase 3 study began evaluating imsidolimab for treatment of generalized pustular psoriasis flares.

[ClinicalTrials.gov — GEMINI-1 study record](https://clinicaltrials.gov/study/NCT05352893)

## Related Pages

- VNDA PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/VNDA.md

- VNDA company profile: https://biopharmsignal.com/company/VNDA.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md