Stoke Therapeutics, Inc.
STOK evidence brief
What we can confirm
- BioSniper Score:
- 4.3 / 10
- Market Cap:
- $1.94B
- Lead Asset:
- stk-002 (Phase 1)
What it means
What to watch
Prepared research question
What matters most for STOK—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · STOK
Stoke Therapeutics, Inc. (STOK) is a biotechnology company developing RNA medicines, with a lead candidate zorevunersen for Dravet syndrome, currently in a global Phase 3 study and planning a rolling NDA submission in the first half of 2027.
Key risk: Regulatory uncertainty
BioSniper Score
Based on 4 of 6 signals
Market Cap
$1.94B
Cash Runway
—
Lead Asset
stk-002 (Phase 1)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate · 3 clinical trials for Stoke Therapeutics, Inc..
Stoke Therapeutics, Inc. (STOK) is a biotechnology company developing RNA medicines, with a lead candidate zorevunersen for Dravet syndrome, currently in a global Phase 3 study and planning a rolling NDA submission in the first half of 2027.
- Lead candidate zorevunersen is in a global pivotal Phase 3 study (EMPEROR) for Dravet syndrome; final patient expected to be randomized in June 2026 and data anticipated in mid-2027 [sec_mda · as of 2026-05-07].
- Company plans to initiate a rolling NDA submission for zorevunersen in the first half of 2027 [sec · filed 2026-01-12].
- Cash & equivalents of $110.0M as of 2026-06-30 [sec].
- Total revenue of $9.3M and net income of -$61.6M for the period ended 2026-06-30 [sec].
- Shareholders' equity of $345.5M as of 2026-06-30 [sec].
What works
- Strong cash position of $110.0M as of 2026-06-30, with news reports indicating a cash runway to 2028 [sec] [news · published 2026-08-05].
- Zorevunersen is advancing through a global pivotal Phase 3 study with a clear regulatory path, including a planned rolling NDA submission in first half of 2027 [sec_mda · as of 2026-05-07] [sec · filed 2026-01-12].
- The company has a partnership with Biogen for zorevunersen, providing potential upside from collaborations [news · published 2026-05-07].
What to weigh
- The company is pre-revenue from product sales, with a net loss of -$61.6M for the period ended 2026-06-30 and reliance on external financing to fund operations [sec] [sec_mda · as of 2026-08-03].
- Regulatory approval is uncertain; the FDA has requested additional information and no immediate changes to the development program were agreed at a recent multidisciplinary meeting [sec · filed 2026-01-12].
- The company may be unable to raise additional funds on favorable terms or at all, which could negatively impact its financial condition [sec_mda · as of 2026-08-03].
From the filings
Quoted directly from source documents.
Planned rolling NDA submission in first half of 2027
“The Company plans to initiate a rolling NDA submission in the first half of 2027.”
SEC filings · January 12, 2026
Phase 3 EMPEROR study data anticipated in mid-2027
“Data from this LP cohort of approximately 150 patients are anticipated in mid-2027 and are expected to be the final data required for completion of the planned rolling U.S. NDA submission.”
SEC MD&A · May 7, 2026
Risks & what to watch (3)›
Key risks
- Regulatory uncertainty — FDA requested additional information; no immediate changes to zorevunersen program agreed [sec · filed 2026-01-12].
- Pre-revenue dependence on financing — Net loss of -$61.6M and reliance on equity/debt/collaborations to fund operations [sec] [sec_mda · as of 2026-08-03].
- Capital raising risk — May be unable to raise additional funds on favorable terms or at all, impacting financial condition [sec_mda · as of 2026-08-03].
What to watch
- Final patient randomization in Phase 3 EMPEROR study expected June 2026 [sec_mda · as of 2026-05-07].
- Phase 3 data readout anticipated mid-2027 [sec_mda · as of 2026-05-07].
- Rolling NDA submission initiation in first half of 2027 [sec · filed 2026-01-12].
- Cash runway updates; news reports indicate runway to 2028 [news · published 2026-08-05].
Sources: News · SEC filings · SEC MD&A · Generated September 27, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.14 · 0% dilution
Lead: Phase 1
1 candidate
No upcoming catalysts tracked
0 buys · 13 sells (180d)
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
197
Total value held
$2.24B
| Holder | Shares | Value |
|---|---|---|
| rtw investments, lp | 5,623,525 | $183.1M |
| blackrock, inc. | 5,385,714 | $175.4M |
| fmr llc | 5,383,666 | $175.3M |
| lynx1 capital management lp | 4,763,673 | $155.1M |
| redmile group, llc | 4,164,120 | $135.6M |
| morgan stanley | 3,423,280 | $111.5M |
| baker bros. advisors lp | 3,336,697 | $108.6M |
| toronto dominion bank | 3,173,258 | $103.3M |
| wellington management group llp | 3,095,700 | $100.8M |
| bvf inc/il | 2,547,557 | $82.9M |
Showing top 10 of 197 institutional holders of Stoke Therapeutics, Inc.. Open the full 13F history after sign-in.
Short Interest
as of Apr 20, 2026- % of float
- 25.8%
- Days to cover
- 13.3
- Shares short
- 12,818,891
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
STOK short interestGovernance
Frequently asked questions
What is the AI investment thesis for Stoke Therapeutics, Inc.?
Stoke Therapeutics, Inc. (STOK) is a biotechnology company developing RNA medicines, with a lead candidate zorevunersen for Dravet syndrome, currently in a global Phase 3 study and planning a rolling NDA submission in the first half of 2027.
What is Stoke Therapeutics, Inc.'s lead drug candidate?
Stoke Therapeutics, Inc.'s most advanced tracked candidate is stk-002 (Phase 1) for autosomal dominant optic atrophy (ADOA).
Who is the CEO of Stoke Therapeutics, Inc.?
Mr. Ian F. Smith A.C.A., C.P.A. is the chief executive officer of Stoke Therapeutics, Inc. (STOK).
Where is Stoke Therapeutics, Inc. headquartered?
Stoke Therapeutics, Inc. (STOK) is headquartered in Bedford, MA, United States.
What therapeutic areas does Stoke Therapeutics, Inc. focus on?
Stoke Therapeutics, Inc. develops therapies across Oncology, Neurology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.