STOKStoke Therapeutics, Inc.

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IntactLast material event Oct 6, 2026 · Updated Nov 3, 2026

EMPEROR Phase 3 data in 3Q 2027 will decide zorevunersen's Dravet NDA

Stoke Therapeutics develops zorevunersen, an RNA medicine injected into spinal fluid for Dravet syndrome, a severe childhood epilepsy; it is not approved, and Biogen holds rights outside the U.S., Canada and Mexico.

Zorevunersen aims to treat Dravet's underlying cause by raising NaV1.1 protein. Supportive open-label findings leave the investment case dependent on EMPEROR confirming seizure reduction and cognition benefits versus sham. Results are anticipated in the third quarter of 2027, NDA completion in the second half of 2027 and a potential launch in early 2028. Management expects $358.8 million to fund operations into early 2028. STK-002 offers a second clinical opportunity, with initial safety and efficacy results anticipated in the first half of 2027.

Thesis checklist

0 risks need attention

Select a row for evidence
EMPEROR confirms seizure reductionAwaiting evidenceNext: EMPEROR results comparing seizures with sham, alongside durability and cognition outcomes.

Why it is in this state

The evidence, what would weaken it and the source filing

FDA accepts the NDA planSupportedNext: Data submissions throughout the first half of 2027 and planned NDA completion in the second half of 2027.

Why it is in this state

The evidence, what would weaken it and the source filing

STK-002 shows benefit in ADOAAwaiting evidenceNext: Initial safety and efficacy results from cohorts three and four, anticipated in the first half of 2027.

Why it is in this state

The evidence, what would weaken it and the source filing

Cash funds the launch planSupportedNext: Next quarterly cash and spending update against management's funding outlook.

Why it is in this state

The evidence, what would weaken it and the source filing

Next decision point

EMPEROR Phase 3 results

Tests: EMPEROR confirms seizure reduction

Third quarter of 2027 (company guidance)

Does zorevunersen reduce seizures versus sham at Week 28, with durable benefit and improved cognition and behavior at Week 52?

Strong, inconclusive and weak outcomes

What to look for in the result and how each would move the checklist

Questions to investigate

History

Price and material events

Select an event marker to read the update below. Marker colors show Thesis status.

IntactCurrentClinical
-3.8%Oct 6, 2026

EMPEROR Phase 3 data in 3Q 2027 will decide zorevunersen's Dravet NDA

IntactClinical
+1.0%Jun 30, 2026

Phase 3 fully enrolled with zero discontinuations; approval hinges on whether double-blind data confirm four years of open-label durability

About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.

Pipeline

Dravet syndrome
zorevunersen · 3 upcoming · 6 completed
Phase 3 DataEMPERORPivotal
Q3 2027
NDA Submission
2H 2027
Regulatory Decision
early 2028
SYNGAP-1 genetic neurodevelopmental disease
STK-SYNGAP-1 · 1 upcoming
SYNGAP-1 clinical candidate identification
2026
Autosomal Dominant Optic Atrophy
STK-002 · 2 upcoming · 1 completed
Phase 1 Enrollment: CompletionOSPREY
Year-end 2026
Phase 1 DataOSPREY
H1 2027

Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.

Quick answers

Is the Stoke Therapeutics (STOK) investment thesis intact?
Yes. Readouts currently rates the Stoke Therapeutics Thesis Intact. EMPEROR Phase 3 data in 3Q 2027 will decide zorevunersen's Dravet NDA.
What is the next catalyst for Stoke Therapeutics (STOK)?
The next dated event is Phase 1 enrollment complete (OSPREY) for STK-002, expected year-end 2026, as stated by the company. Also ahead: Phase 1 results (OSPREY) for STK-002, expected H1 2027.
How long will Stoke Therapeutics' cash last?
Stoke Therapeutics has said its cash will fund operations into early 2028 (guidance as of November 3, 2026). It reported $359 million in cash as of September 30, 2026.

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Competitive landscape

1 peers tracked

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Financial snapshot

Dates and calculation details

Cash: Market-data provider estimate; measurement period unavailable.

Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.

Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.

Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.

Runway: No underlying guidance available.