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 (imsidolimab): PDUFA target action date (December 2026).
Upcoming catalysts
- December 2026Quimilza (imsidolimab) — PDUFA target action date
The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.
Next further out: BYSANTI (milsaperidone) — Phase III MDD study results (H1 2027). 3 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 (GPP) | antibody | Phase 3 |
| BYSANTI | Major Depressive Disorder (MDD) | small molecule | Phase 3 |
| NEREUS (tradipitant) | Prevention of vomiting induced by GLP-1 receptor agonists | small molecule | Phase 3 |
| HETLIOZ (tasimelteon) | Delayed Sleep-Wake Phase Disorder (DSWPD) | small molecule | Phase 3 |
| VQW-765 | Social/performance anxiety and psychiatric disorders | small molecule | Phase 3 |
| Fanapt long acting injectable | Schizophrenia and hypertension | small molecule | Pre-clinical |
| HETLIOZ | Jet lag disorder, insomnia, pediatric insomnia, pediatric Non-24 | small molecule | Pre-clinical |
| PONVORY (ponesimod) | Ulcerative colitis and psoriasis | small molecule | Pre-clinical |
| NEREUS (tradipitant) | Gastroparesis | small molecule | Pre-clinical |
| VSJ-110 | Dry eye and ocular inflammation | small molecule | Pre-clinical |
| VPO-227 | Secretory diarrhea disorders, including cholera | small molecule | Pre-clinical |
| VTR-297 | Hematologic malignancies and onychomycosis | small molecule | Pre-clinical |
Recent results and decisions
- Oct 28, 2026n/a The BLA for Quimilza in GPP is under FDA review with a PDUFA target action date of December 12, 2026.
The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.
Filing - Oct 28, 2026submitted The Biologics License Application for Quimilza in Generalized Pustular Psoriasis is under review by the FDA with a PDUFA target action date of December 12, 2026.
The Biologics License Application (BLA) for Quimilza™ in Generalized Pustular Psoriasis (GPP) is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.
Filing - positive Vanda announced positive results from the Phase III clinical study of NEREUS for prevention of vomiting associated with GLP-1 receptor agonist therapy.
In October 2026, Vanda announced positive results from the Phase III clinical study, VP-VLY-686-3601, of NEREUS™ for the prevention of vomiting associated with GLP-1 receptor agonist therapy.
Filing
8 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.