Name in SEC filings: Vanda Pharmaceuticals Inc.
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| Quimilza | target date (company stated) | PDUFA | December 12, 2026 | 10-Q · |
| HETLIOZ | /data readout | Phase 3 | in 2026 | 10-Q · |
| NEREUS | Topline/data readout | Phase 3 | in 2026 | 10-Q · |
| VQW-765 | Topline/data readout | Phase 3 | in 2026 | 10-Q · |
| BYSANTI | Topline/data readout | Phase 3 | in the first half of 2027 | 10-Q · |
Source: ORION, orionbiotechai.com/company/VNDA, data as of Oct 17, 2026
https://www.orionbiotechai.com/company/VNDA
Quimilza · PDUFA target date (company stated) · December 12, 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
PDUFA target date (company stated)December 12, 2026
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $268,700,000 · as of · SEC filing
The Biologics License Application (BLA) for QuimilzaTM in GPP is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutin 2026
Stage: Phase 3SEC filing · “Phase III”
Public float: $268,700,000 · as of · SEC filing
The Phase III study of HETLIOZ® in the treatment of delayed sleep phase disorder (DSPD) with results expected in 2026.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutin 2026
Stage: Phase 3SEC filing · “Phase III”
Public float: $268,700,000 · as of · SEC filing
The Thetis Phase III study of NEREUSTM for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutin 2026
Stage: Phase 3SEC filing · “Phase III”
Public float: $268,700,000 · as of · SEC filing
The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected in 2026.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readoutin the first half of 2027
Stage: Phase 3SEC filing · “Phase III”
Public float: $268,700,000 · as of · SEC filing
The Phase III study of BYSANTITM as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in the first half of 2027.
10-Q · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2027-06)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| BYSANTIClinical results | in the first half of 2027“The Phase III study of BYSANTITM as a once-daily adjunctive treatment for major depressive disorder (MDD), with results expected in the first half of 2027.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| HETLIOZClinical results | in 2026“The Phase III study of HETLIOZ® in the treatment of delayed sleep phase disorder (DSPD) with results expected in 2026.” Filed · 10-Q | Still within period As of Oct 19, 2026 |
| NEREUSClinical results | in 2026“The Thetis Phase III study of NEREUSTM for the prevention of vomiting in patients receiving GLP-1 receptor agonist therapies, with results expected in 2026.” Filed · 10-Q | Still within period As of Oct 19, 2026 |
| QuimilzaFDA decision | December 12, 2026“The Biologics License Application (BLA) for QuimilzaTM in GPP is under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of December 12, 2026.” Filed · 10-Q | Period not started The stated period has not started yet, so there is nothing to compare. |
| VQW-765Clinical results | in 2026“The Phase III study of VQW-765 in the treatment of adults with social anxiety disorder, with results expected in 2026.” Filed · 10-Q | Still within period As of Oct 19, 2026 |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
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