The complete enrollment and zero discontinuations significantly de-risk the pivotal readout. Traders should monitor for: (1) any disclosure of baseline characteristics or blinded safety data, (2) enrollment updates on the European cohort, and (3) initiation of the rolling NDA in Q1 2027. The stock is likely to trade on these macro milestones until Q3 2027 data.
Price Chart
Executive Summary
Stoke Therapeutics completed enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen for Dravet syndrome, ahead of a Phase 3 data readout anticipated in Q3 2027 and a rolling NDA submission expected to begin in Q1 2027. This de-risks the pivotal trial timeline and sets up a potential U.S. launch by early 2028, though no efficacy or safety data have been released yet.
Key Facts
- Enrollment of 162 patients into the Phase 3 EMPEROR study of zorevunersen completed across U.S., U.K., and Japan.
- No patients have discontinued treatment in the study.
- Phase 3 data readout anticipated in Q3 2027; rolling NDA submission to FDA to begin Q1 2027 and complete H2 2027.
- Approximately 50 of 162 patients are through 28 weeks (primary endpoint of change in major motor seizure frequency).
- An additional cohort of ~30 patients in Europe is enrolling with last patient expected in August 2026.
- Stoke has a strategic collaboration with Biogen (Nasdaq: BIIB) for zorevunersen; Stoke retains U.S., Canada, Mexico rights.
- Zorevunersen has FDA Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Orphan Drug Designation.
Financial Impact
Enrollment completion and zero discontinuations reduce binary Phase 3 risk, supporting a potential U.S. launch by early 2028 for a first-in-class therapy targeting up to 38,000 patients in key markets (U.S. ~16,000). No financial terms disclosed.
Risk Factors
- Efficacy or safety failure at Phase 3 readout could wipe out value; the drug has not yet proven it works in a pivotal setting.
- Regulatory delays or need for additional trials beyond the current plan.
- Competition from other Dravet syndrome therapies, including ASMs and gene therapies in earlier development.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-289409 |
| Document: d924679dex991.htm | 0001193125-26-289409 |
| Document: 0001193125-26-289409-index-headers.html | 0001193125-26-289409 |
| Document: 0001193125-26-289409-index.html | 0001193125-26-289409 |
| Document: 0001193125-26-289409.txt | 0001193125-26-289409 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 19, 2026 6w ago | Insider Cluster | $33.03 $28.93 | ▼ −12.41% | ▼ −10.46% | $25.91 (−21.56%) |
Aug 3, 2026 8w ago | 8-K | $31.67 $30.89 | ▲ +2.46% | ▲ +1.22% | $25.91 (+18.19%) |
Aug 3, 2026 8w ago | 424B5 | $31.67 $30.89 | ▲ +2.46% | ▲ +1.22% | $25.91 (+18.19%) |
Jun 30, 2026 13w ago | 8-K | $32.72 $29.31 | ▼ −10.42% | ▼ −9.39% | $25.91 (−20.82%) |
May 7, 2026 21w ago | 8-K | $32.89 $30.01 | ▼ −8.76% | ▼ −8.78% | $25.91 (−21.23%) |
Apr 22, 2026 23w ago | DEFA14A | $34.93 $30.30 | ▼ −13.27% | ▼ −17.90% | $25.91 (−25.83%) |
Apr 7, 2026 25w ago | 8-K | $34.87 $32.96 | ▼ −5.48% | ▼ −14.02% | $25.91 (−25.70%) |
Mar 13, 2026 29w ago | Insider Cluster | $33.19 $35.05 | ▼ −5.60% | ▼ −2.02% | $25.91 (+21.94%) |
Mar 10, 2026 29w ago | Insider Cluster | $38.35 $34.87 | ▼ −9.07% | ▼ −8.92% | $25.91 (−32.44%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access