Vanda Pharmaceuticals Inc. VNDA
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) is a dermatology drug developer. Its lead program, Quimilza (imsidolimab), is in Phase 3 for Generalized pustular psoriasis (GPP). Its next catalyst on record is Quimilza: FDA PDUFA action date for BLA (December 12, 2026).
Upcoming catalysts
- December 12, 2026Quimilza — FDA PDUFA action date for BLA
PDUFA target action date of December 12, 2026
Next further out: Bysanti — Commercial launch (H2 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Quimilza (imsidolimab) | Generalized pustular psoriasis | antibody | Phase 3 |
| Nereus (tradipitant) | Motion sickness vomiting (approved); gastroparesis / other indications in Phase III | small molecule | Phase 3 |
| VQW-765 | Social anxiety (performance) | small molecule | Phase 3 |
| Hetlioz | Delayed sleep phase disorder | small molecule | Phase 3 |
| Bysanti | Major depressive disorder (adjunct) | small molecule | Phase 3 |
Recent results and decisions
- May 6, 2026accepted FDA accepted the imsidolimab BLA for GPP with a PDUFA target action date of December 12, 2026.
The FDA accepted the Biologics License Application (BLA) for imsidolimab in Generalized Pustular Psoriasis (GPP) with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.
Filing - Feb 20, 2026approval FDA approved BYSANTI (milsaperidone), a new chemical entity, for schizophrenia and acute manic/mixed episodes of bipolar I disorder in adults.
the U.S. Food and Drug Administration (FDA) has approved BYSANTI (milsaperidone) tablets, a first line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia in adults.
Filing - Jan 8, 2026CRL FDA CDER decision letter after re-review concluded the HETLIOZ sNDA for jet lag disorder cannot be approved in its current form; Vanda disagrees.
concluding that the supplemental New Drug Application (sNDA) for HETLIOZ (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 dermatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.