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olivLaw · US equity research

Stoke Therapeutics, Inc. STOK

Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)

26.07USD−5.03% · 1 dayClose 05 Nov 2026

Stoke Therapeutics is a late-stage biotechnology company developing RNA-based medicines that restore protein levels, with its lead candidate zorevunersen targeting Dravet syndrome, a severe genetic epilepsy. The company's Phase 3 EMPEROR study has completed enrollment of 162 patients, with data expected in Q3 2027. For the near term, the funding picture depends on the company's ability to raise further capital, with the reported 420 million dollars in cash said to be enough, if the current pace holds, until a possible U.S. launch in early 2028.

The AI analysis may be outdated: new filings came after its sources (see the «AI analysis» section).

At the close of 05 Nov 2026, Stoke Therapeutics, Inc. (STOK) stock was 26.07 USD (−5.03% on the day), with market capitalisation 1.7 bn USD, beta 1.03, 52-week range 22.37–38.35 USD. Latest reported quarter (Q3 2026): revenue of 11.3 m USD (+5.9% YoY), net income of -73.6 m USD, diluted EPS -1.08 USD.

Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.

Market cap
1.7 bn USD
shares as of 30 Oct 2026
P/E (TTM)
unavailable
Diluted EPS TTM -3.84 · TTM to 30 Sept 2026
E/P (TTM)
-14.73%
TTM to 30 Sept 2026
Dividend yield
unavailable
Beta (2y)
1.03
Volatility (1y) 55%
52-week range
22.3738.35

Price history

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Technical reading

RSI (14)
49.5
neutral
Bollinger (20, 2)
22.96 – 27.93
in the upper half of the band · %B 0.63 · band width 19.5%
SMA 50 / 200
26.95 / 30.87
downtrend (price < SMA50 < SMA200)
MACD (12, 26, 9)
0.09 / -0.21
MACD above signal

Indicators describe past prices; on their own they do not predict direction. On our history the RSI ≤ 40 filter added no return (see the signals methodology).

Performance

CompanyS&P 500vs S&P 500Vertical median
1 month+7.0%−5.9%+12.9 pp—
3 months−18.4%−4.6%−13.7 pp—
6 months−20.5%+0.2%−20.7 pp—
Year to date−17.9%+7.4%−25.3 pp—
1 year+14.2%+8.2%+6.0 pp+4.8%
3 years+504.9%+68.4%+436.4 pp+38.9%
5 years+0.4%+56.5%−56.2 pp—
Max drawdown (1y)
−41.3%
10 Mar 2026 → 13 Oct 2026
Max drawdown (5y)
−89.0%
22 Nov 2021 → 27 Oct 2023
Compound annual growth (5y)
+0.1%
S&P 500 +9.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q3 2026 · 30 Sept 2026

Revenue
11.3 m USD
+5.9% YoY
Net income
-73.6 m USD
unavailable YoY
Diluted EPS
-1.08
unavailable YoY
net / operating
-654.3% / -686.9%

Quarterly margins

Quarterly statements · USD

Fiscal yearQ4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26Q3 '26
Revenue22.6 m158.6 m13.8 m10.6 m1.4 m6.2 m9.3 m11.3 m
Research & development23.4 m32.7 m25.9 m37.7 m41.7 m39.7 m49.5 m59.8 m
SG&A12.8 m14.7 m15.3 m16.0 m21.1 m20.0 m25.3 m28.7 m
Operating income-13.7 m111.2 m-27.3 m-43.1 m-61.4 m-53.4 m-65.4 m-77.3 m
Interest expense-1.0 k1.0 k3.0 k3.0 k3.0 k23.0 k17.0 k20.0 k
Pre-tax income—114.2 m-23.5 m-39.6 m—-50.0 m-61.6 m-73.6 m
Income tax—1.3 m0-1.3 m0000
Net income-10.5 m112.9 m-23.5 m-38.3 m-57.9 m-50.0 m-61.6 m-73.6 m
Diluted EPS-0.18 ≈1.90-0.40-0.65-1.04 ≈-0.79-0.93-1.08
Operating cash flow-23.2 m131.8 m-25.4 m ≈-30.4 m ≈-30.5 m-60.6 m-56.6 m ≈-62.7 m ≈
Capex42.0 k152.0 k154.0 k ≈132.0 k ≈232.0 k353.0 k2.0 m ≈2.9 m ≈

≈ derived quarter (cumulative difference / share-days average)

E/P over time

E/P = trailing-12-month diluted EPS / price at quarter end. E/P is the inverse of P/E and stays defined when earnings are negative.

Fiscal years

Fiscal year20182019202020212022202320242025
Revenueunavailableunavailableunavailableunavailable12.4 m8.8 m36.6 m184.4 m
Revenue YoYunavailableunavailableunavailableunavailableunavailable−29.2%+316.3%+404.5%
Net income-12.5 m-32.3 m-52.2 m-85.8 m-101.1 m-104.7 m-89.0 m-6.9 m
Net income YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
Diluted EPSunavailableunavailableunavailable-2.34-2.60-2.38-1.65-0.12
Diluted EPS YoYunavailableunavailableunavailableunavailableunavailableunavailableunavailableunavailable
net %unavailableunavailableunavailableunavailable-814.7%-1,192.5%-243.4%-3.7%
Free cash flow-11.9 m-32.7 m-43.3 m-68.1 m-35.8 m-82.7 m-87.1 m44.9 m

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
84.2 m USD
Financial debt
unavailable USD
Net debt
unavailable USD
Equity
352.5 m USD
Total assets
418.4 m USD
Debt / equity
unavailable
Current ratio
5.28x
ROE
-2.4%
ROA
-2.0%
FCF margin
24.4%

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
8.8 m
2024
36.6 m
2025
184.4 m

SEC (XBRL)· 16 Mar 2026verified

Research & development
2023
82.2 m
2024
89.1 m
2025
137.9 m

SEC (XBRL)· 16 Mar 2026verified

SG&A
2023
—
2024
48.8 m
2025
67.1 m

SEC (XBRL)· 16 Mar 2026verified

Operating income
2023
-114.8 m
2024
-101.4 m
2025
-20.6 m

SEC (XBRL)· 16 Mar 2026verified

Interest expense
2023
49.0 k
2024
26.0 k
2025
9.0 k

SEC (XBRL)· 16 Mar 2026verified

Income tax
2023
—
2024
—
2025
0

SEC (XBRL)· 16 Mar 2026verified

Net income
2023
-104.7 m
2024
-89.0 m
2025
-6.9 m

SEC (XBRL)· 16 Mar 2026verified

Diluted EPS
2023
-2.38
2024
-1.65
2025
-0.12

SEC (XBRL)· 16 Mar 2026verified

Weighted average diluted shares
2023
44.0 m
2024
54.0 m
2025
59.2 m

SEC (XBRL)· 16 Mar 2026verified

Balance sheet · USD

Cash
2023
191.4 m
2024
128.0 m
2025
84.2 m

SEC (XBRL)· 16 Mar 2026verified

Receivables
2023
—
2024
1.7 m
2025
5.9 m

SEC (XBRL)· 16 Mar 2026verified

Current assets
2023
215.3 m
2024
232.8 m
2025
305.7 m

SEC (XBRL)· 16 Mar 2026verified

Property, plant & equipment, net
2023
5.8 m
2024
3.9 m
2025
3.1 m

SEC (XBRL)· 16 Mar 2026verified

Total assets
2023
228.3 m
2024
271.6 m
2025
418.4 m

SEC (XBRL)· 16 Mar 2026verified

Accounts payable
2023
1.7 m
2024
2.5 m
2025
4.9 m

SEC (XBRL)· 16 Mar 2026verified

Current liabilities
2023
30.8 m
2024
40.1 m
2025
57.9 m

SEC (XBRL)· 16 Mar 2026verified

Total liabilities
2023
68.8 m
2024
42.5 m
2025
66.0 m

SEC (XBRL)· 16 Mar 2026verified

Equity
2023
159.6 m †
2024
229.0 m †
2025
352.5 m †

SEC (XBRL)· 16 Mar 2026verified

Cash flow · USD

Operating cash flow
2023
-81.1 m
2024
-86.9 m
2025
45.6 m

SEC (XBRL)· 16 Mar 2026verified

Capex
2023
1.6 m
2024
203.0 k
2025
670.0 k

SEC (XBRL)· 16 Mar 2026verified

Free cash flow
2023
-82.7 m ≈
2024
-87.1 m ≈
2025
44.9 m ≈

SEC (XBRL)· 16 Mar 2026derived

Investing cash flow
2023
105.9 m
2024
-107.5 m
2025
-186.8 m

SEC (XBRL)· 16 Mar 2026verified

Financing cash flow
2023
53.0 m
2024
131.1 m
2025
97.4 m

SEC (XBRL)· 16 Mar 2026verified

Computed indicators

Growth

Revenue growth (YoY)
404.5%
computed by olivLawFY 2025
Revenue CAGR 3Y
145.9%
computed by olivLawFY 2022 → FY 2025
Revenue CAGR 5Y
unavailable
input data missing
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
unavailable
the base of the ratio is not positive
Net income CAGR 3Y
unavailable
the base of the ratio is not positive
Net income CAGR 5Y
unavailable
the base of the ratio is not positive
EPS growth (YoY)
unavailable
the base of the ratio is not positive
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
input data missing
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
unavailable
input data missing
EBITDA margin
unavailable
input data missing
EBIT margin
-913.1%
computed by olivLawTTM to 30 Sept 2026
Net margin
-862.1%
computed by olivLawTTM to 30 Sept 2026
FCF margin
-764.7%
computed by olivLawTTM to 30 Sept 2026

Returns

ROE
-73.6%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
ROA
-63.4%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
ROIC
unavailable
input data missing
ROCE
-72.0%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Payout ratio (EPS)
unavailable
input data missing
Payout ratio (FCF)
unavailable
input data missing

Balance sheet

Net debt
unavailable
input data missing
Net debt / EBITDA
unavailable
input data missing
Debt / equity
unavailable
input data missing
Interest coverage
-4,088.9x
computed by olivLawTTM to 30 Sept 2026

Liquidity

Current ratio
7.2x
computed by olivLawbalance sheet at 30 Sept 2026
Quick ratio
unavailable
input data missing
Cash ratio
2.2x
computed by olivLawbalance sheet at 30 Sept 2026

Cash

Operating cash flow
-210.3 m USD
computed by olivLawTTM to 30 Sept 2026
Capital expenditure
5.4 m USD
computed by olivLawTTM to 30 Sept 2026
Free cash flow
-215.7 m USD
computed by olivLawTTM to 30 Sept 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
115 days
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Days inventory outstanding
unavailable
input data missing
Days payables outstanding
unavailable
input data missing
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
1.7 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-14.7%
computed by olivLawTTM to 30 Sept 2026
P/B
4.8x
computed by olivLawbalance sheet at 30 Sept 2026
P/S
60.4x
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
EV/EBITDA
unavailable
input data missing
EV/EBIT
unavailable
input data missing
EV/Sales
unavailable
input data missing
P/FCF
unavailable
the base of the ratio is not positive
FCF yield
-12.7%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero
Shareholder yield (distributions)
unavailable
input data missing

1 indicators that do not apply to the sector.

Valuation

olivLaw classification

Insufficient data
What is missing
  • indicators available: 5 of at least 6
  • score weight coverage: 33.3% of at least 60%
  • valuation methods computed: 0 of at least 1

A scoring methodology on indicators and valuation, not investment advice.

Closing price

26.07 USD

05 Nov 2026Source: olivLaw, closing series

Market cap: 1.7 bn USD

Key indicators

Market capitalisation
1.7 bn USD
computed by olivLawbalance sheet at 30 Sept 2026
P/E (TTM)
unavailable
insufficient data
P/B
4.8x
computed by olivLawbalance sheet at 30 Sept 2026
EV/EBITDA
unavailable
input data missing
ROE
-73.6%
computed by olivLawTTM to 30 Sept 2026 · balance sheet at 30 Sept 2026
Net margin
-862.1%
computed by olivLawTTM to 30 Sept 2026
Revenue growth (YoY)
404.5%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

23/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Sept 2026
Latest balance sheet date: 30 Sept 2026
Share count (cover of the latest filing), as of: 30 Oct 2026
Source: SEC (XBRL)published 03 Nov 2026
verified 877derived 59

Score by group

33% · Insufficient data

Estimated value range

unavailable — no valuation method could be computed

Valuation assumptions are editorial choices, not measured; beta is not measured.

Valuation methods

  • DCF (discounted cash flow)unavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: EV/EBITDAunavailable · net debt missing: EV cannot be bridged to equity (missing debt is not zero)
  • Peers: P/Eunavailable · the base of the ratio is not positive
  • Dividend discount (DDM)unavailable · the company pays no dividend: a dividend model needs an explicit initiation assumption

no valuation method could be computed

Multiple comparisons use the SIC vertical: Pharmaceutical Preparations (SIC 2834)

Classification (SIC) comparables group by industry code, not by economic activity; the direct group is an editorial selection by activity. Members' multiples are on their own trailing twelve months, at their own latest close.

Assumptions (illustrative, editorial)

Risk-free rate
4.3%
Equity risk premium
5.0%
Beta (default)
1.00
Cost of equity
9.3%
Terminal growth
2.5%

Factor scorecard

Insufficient data

Minimum-evidence gate: indicators available: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Quality-862.1%15 (vs peers)19%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growth145.9%100 (on a fixed band)25%
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheet-4,088.9x0 (on a fixed band)19%
Current ratio · Balance sheet7.2x100 (on a fixed band)13%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-12.7%0 (on a fixed band)25%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

Factors without a value were dropped; the remaining weights were renormalised.

Score groups

  • Balance sheet40/100 · 2/3 factors with a value
  • Growth· partial100/100 · 1/2 factors with a value
  • Quality· partial15/100 · 1/3 factors with a value
  • Returns· partialunavailable · 0/2 factors with a value
  • Valuation· partial0/100 · 1/3 factors with a value

A «partial» group is computed from under half of its weight or from one factor: it is not a full assessment of the group.

Memo

Stoke Therapeutics, Inc. (STOK). Latest full fiscal year: 2025; data up to 2026-09-30.

Figures computed from the financial statements: revenue 184.4 m USD in 2025; YoY growth 404.5%; net margin -862.1%; ROE -73.6%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 5 of at least 6; score weight coverage: 33.3% of at least 60%; valuation methods computed: 0 of at least 1).

Text generated deterministically from the figures shown; no language model. Not investment advice.

What supports the thesis

  • Revenue CAGR 3Y: 145.9%
  • Current ratio: 7.2x

What contradicts it

  • Net margin: -862.1%
  • Interest coverage: -4,088.9x
  • FCF yield: -12.7%

Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, P/E (TTM), EV/EBITDA, Shareholder yield (distributions), Payout ratio (FCF).

Versus the vertical median

Pharmaceutical Preparations (SIC 2834) · same industry (4-digit SIC) · compared with 39 companies

Multiples and returns vs the median

P/E
—
vertical median 34.9x
EV/EBITDA
—
vertical median 25.2x
P/S
60.4x
vertical median 7.6x
above median (+699.6%)
P/B
4.8x
vertical median 3.3x
above median (+47.6%)
ROE
-73.6%
vertical median -6.2%
below median
Net margin
-862.1%
vertical median 3.6%
below median (−23,779.0%)
EBIT margin
-913.1%
vertical median -0.0%
below median
Revenue YoY
404.5%
vertical median 4.3%
above median (+9,272.6%)
Net debt/EBITDA
—
vertical median -0.1x
Dividend yield
—
vertical median 2.1%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
LLYEli Lilly And Company1,283.9 bn44.386.1%31.9%+44.7%+27% / +131%
JNJJohnson & Johnson655.6 bn41.320.0%16.2%+6.0%+32% / +76%
ONCBeone Medicines Ltd.575.0 bn640.918.4%13.9%+40.2%+14% / +107%
ABBVAbbVie Inc.509.5 bn49.6—15.7%+8.6%+27% / +102%
MRKMerck & Co., Inc.362.2 bn151.25.1%3.6%+1.3%+40% / +43%
ABTAbbott Laboratories196.7 bn42.39.2%9.7%+5.7%−12% / +9%
PFEPfizer Inc170.3 bn42.64.4%6.3%−1.6%+16% / −2%
VRTXVertex Pharmaceuticals Inc137.5 bn34.920.8%30.7%+8.9%+25% / +53%
BMYBristol-Myers Squibb Company129.0 bn14.044.1%18.5%−0.2%+28% / +28%
TEVATeva Pharmaceutical Industries Limited48.8 bn97.36.6%3.6%+4.3%+55% / +325%
ZTSZoetis Inc.33.4 bn13.857.6%26.4%+2.3%−36% / −54%
ROIVRoivant Sciences Ltd.26.5 bn—-6.2%-3,535.0%−71.6%+76% / +283%
RPRXRoyalty Pharma plc26.2 bn47.76.9%25.7%+5.1%+69% / +150%
UTHRUnited Therapeutics Corporation24.1 bn21.319.1%38.6%+10.6%+16% / +136%
INSMInsmed Inc23.9 bn—-72.5%-39.9%+66.7%−48% / +335%
VTRSViatris Inc.21.7 bn—-24.3%-23.9%−3.0%+77% / +107%
ALNYAlnylam Pharmaceuticals, Inc.21.0 bn7.9126.6%52.8%+65.2%−65% / −7%
IDYAIDEAYA Biosciences, Inc.3.0 bn—-38.5%-1,149.6%+3,024.4%−14% / −3%
RCUSArcus Biosciences, Inc.2.5 bn—-114.1%-453.0%−4.3%−32% / +17%
STOKStoke Therapeutics, Inc.1.7 bn—-73.6%-862.1%+404.5%+14% / +505%
INVAInnoviva, Inc.1.4 bn9.717.0%44.1%+14.7%−11% / +39%
JANXJanux Therapeutics, Inc.982.6 m—-10.6%-428.7%−5.6%−53% / +84%
WVEWave Life Sciences, Inc.635.1 m—-80.0%-296.9%−60.5%−59% / −39%
NGNENeurogene Inc.513.3 m—-45.3%—−100.0%+22% / +85%
DMACDiaMedica Therapeutics Inc.487.5 m—-114.6%—unavailable+5% / +270%

1- and 3-year price returns: for STOK from daily closes (the same as the performance table), for the other companies from month-end closes.

olivLaw engine forecast

The world engine ran after the company's latest material disclosure. Probabilities are of TOUCHING a level within the horizon (not closing there) and sit next to the random walk (p_rw), the no-information benchmark.

The engine has no published run for this company yet.

Valuation scenarios (editable assumptions)

Illustrative scenarios

Illustrative: not forecasts and without probabilities. Each case is one coherent set of assumptions, computed on today's figures.

Bear
Allowed range: -50 … 50%
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Base
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
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Allowed range: 0 … 100%
Bull
Allowed range: -50 … 50%
Allowed range: -100 … 100%
Allowed range: 0 … 100
Allowed range: -10 … 20%
Allowed range: 0 … 100%
Nothing is saved.

Estimated price (USD)

Estimated priceBearBaseBull
1 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
3 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
5 years
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
insufficient data
Total return unavailable · Per year unavailable
What moves the 3-year price the most

    AI analysis

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    Possibly outdated: the newest document it read is from 03 Aug 2026; since then the company filed 10-Q (03 Nov 2026), 8-K (29 Oct 2026 · results).

    In brief

    Stoke Therapeutics is a late-stage biotechnology company developing RNA-based medicines that restore protein levels, with its lead candidate zorevunersen targeting Dravet syndrome, a severe genetic epilepsy. The company's Phase 3 EMPEROR study has completed enrollment of 162 patients, with data expected in Q3 2027. For the near term, the funding picture depends on the company's ability to raise further capital, with the reported 420 million dollars in cash said to be enough, if the current pace holds, until a possible U.S. launch in early 2028 3.

    SWOT

    Strengths

    • The company has a Phase 3 program with enrollment complete and no treatment discontinuations reported so far, which supports confidence in the study timeline 3.
    • Zorevunersen holds Breakthrough Therapy designation from the FDA, and long-term data from the extension studies support the safety profile 13.
    • The TANGO platform allows work on a number of haploinsufficient diseases, providing a basis for expanding the pipeline beyond the first program 1.

    Weaknesses

    • The company has no approved products and no sales, and net losses keep rising as development spending increases 13.
    • Dependence on one main product means that the results of a single study weigh heavily on the company's value 1.
    • The company relies on external funding through share issuances and ATM programs, which can dilute existing shareholders 23.

    Opportunities

    • An approval for Dravet syndrome could open the first disease-modifying therapy for a population with no direct alternatives 1.
    • Extending the platform to new haploinsufficient targets and the SYNGAP1 program could diversify the portfolio over the medium term 3.
    • If the Phase 3 data are favorable, existing partnerships could ease access to markets outside the U.S. 1.

    Threats

    • A negative or mixed result in Phase 3 could delay or halt the zorevunersen program, with a major impact on the company 1.
    • Harder market or funding conditions could force a reduction or postponement of activities 12.
    • Legislation and prices set by authorities could limit revenue from an approved medicine 1.

    Risks

    • Phase 3 resultshigh

      Data from the EMPEROR study could fail to confirm the efficacy seen in earlier small studies, and results may differ in larger populations 1. The company states that a seizure effect does not guarantee a disease-modifying effect 1.

    • Funding and dilutionhigh

      The company has said it will need additional capital before it can expect profit, and financing may not be available on acceptable terms 1. Share sales can dilute existing shareholders 23.

    • Approval and regulationmedium

      Authorities could request additional data or approve a narrower indication than the company seeks 1. Approval outside the U.S. depends on separate authorities, which adds uncertainty 1.

    • Patient recruitment and target populationmedium

      The small number of patients and the difficulty of identifying them could delay trial recruitment and slow sales growth 1.

    • Dependence on partnersmedium

      Biogen and Acadia hold rights to some programs, and their decisions could influence the company's timing and revenue, especially after the termination of some programs in 2025 12.

    Investment thesis

    What would need to be true (bull case)

    • Zorevunersen could become the first treatment that modifies the disease in Dravet syndrome, if the Phase 3 data confirm the benefit seen in earlier studies 13.
    • Rapid enrollment of the 162 patients and the absence of treatment discontinuations could indicate a realistic timeline, if the pace holds 3.
    • The platform and the STK-002 program could extend the company's value beyond a single product, if early data are favorable 13.

    What would break the thesis

    • The company has no product revenue, and losses rose significantly in the first half of 2026, which could make new funding necessary 23.
    • A failure or inconclusive result in Phase 3 could heavily affect the value of the program at the centre of the company 1.
    • The market is limited by the small patient count, and access and price are uncertain, which could limit revenue even if approval is obtained 1.

    What to watch

    • Începerea depunerii rolling a NDA pentru zorevunersenQ1 2027
    • Datele pivotale din faza 3 EMPERORQ3 2027
    • Outcome of the pre-NDA meeting with the FDA and confirmation of the data packagesecond half 2026
    • Start of the rolling NDA submission for zorevunersenQ1 2027
    • Pivotal Phase 3 EMPEROR dataQ3 2027
    • Safety and efficacy data from the OSPREY study (STK-002)H1 2027

    Products, market & competition

    AI-generatedAI-generated analysis (Claude) from cited public sources; it may contain errors. Not investment advice. As of 27 Oct 2026 · Model: claude-haiku-5-5.

    Possibly outdated: the newest document it read is from 03 Aug 2026; since then the company filed 10-Q (03 Nov 2026), 8-K (29 Oct 2026 · results).

    The business

    According to its SEC filings, Stoke Therapeutics develops antisense oligonucleotide (ASO) medicines based on its proprietary TANGO platform, which aims to increase protein expression from the healthy copy of a gene 1. Its lead candidate, zorevunersen, targets Dravet syndrome, where about 85% of cases are caused by mutations in the SCN1A gene, and the company states that no approved medicine currently modifies the disease at its cause 1. The second program, STK-002, targets autosomal dominant optic atrophy (ADOA), and the Phase 1 OSPREY study dosed its first patient in February 2026 13. The company has no product sales yet, and its revenue comes from its collaborations with Acadia and Biogen 23.

    On the financial side, Stoke reported a net loss of 61.6 million dollars in the second quarter of 2026, with research and development expenses of 49.5 million dollars, compared with 25.9 million dollars in the same period a year earlier 3. The company says the increase reflects activities and personnel needed to advance zorevunersen, and general and administrative costs rose in parallel with launch preparation 3. Revenue fell to 9.3 million dollars in the second quarter of 2026, because a Biogen licence payment was recognized in 2025 3.

    Segments

    Zorevunersen (Dravet syndrome)

    Zorevunersen is the main program and the only one in Phase 3. The EMPEROR study began in May 2025, and in June 2026 enrollment of 162 patients in the U.S., UK and Japan was completed 3. The company plans to start a rolling New Drug Application (NDA) in the first quarter of 2027, with pivotal results expected in Q3 2027 3. The program holds Breakthrough Therapy Designation from the FDA 1.

    STK-002 (ADOA optic atrophy)

    STK-002 is in the Phase 1 OSPREY study, with dose escalation under way and eight clinical sites active in the UK, Germany, Denmark, Italy and Austria 3. Safety and efficacy data are expected in the first half of 2027, according to the company's release 3. ADOA currently has no approved treatments, which makes the program relevant to patients with few alternatives 1.

    Market context

    Dravet syndrome is a rare condition, with an estimated population of about 15,700 patients in the U.S. alone and about 38,000 across the seven markets the company covers 1. According to sources cited by the company, up to 57% of patients fail to achieve a reduction of over 50% in seizure frequency on current medicines, which supports the view of an unmet medical need 1. The market nevertheless remains of limited size, and access depends on regulatory approval and insurance coverage, which are not yet settled 1.

    The target market is defined by a relatively small number of diagnosed patients, which could make identifying patients and recruiting for trials take longer than expected, and could make sales growth slower if the medicine is approved 1. The company also notes that pricing and reimbursement of a new product are uncertain, and that inadequate coverage could limit its ability to generate revenue 1.

    Trends

    • Accelerated regulatory designationsmixed

      The Breakthrough Therapy designation granted by the FDA and the Rare Pediatric Disease designation are mentioned in the filings, but the company states that they do not guarantee faster development or approval 1. The effect on the company is therefore mixed, since regulatory attention is favorable but does not remove the risk of delay 1.

    • Interest in disease-modifying therapiestailwind

      The filings stress that clinicians regard the need for therapies that treat the cause of the disease, not just seizures, as a priority, which could support adoption of a new medicine if the Phase 3 data are favorable 1. That support is conditional on results, and the company cannot guarantee clinician acceptance 1.

    • Cost of capital and market-based fundingheadwind

      Stoke relies on share issuances and ATM programs for funding, and the August 2026 release reports 65.7 million dollars of net proceeds from a share sale 3. If market conditions deteriorate, funding could become more expensive or harder to obtain, which could affect the timing of programs 12.

    • Health policy and pricingheadwind

      The company notes that existing and future legislation may make approval and commercialization more difficult and may affect the prices it can set 1. The effect is a risk rather than a certainty, since the impact depends on decisions taken by authorities 1.

    Competitive position

    The approved treatments for Dravet syndrome are cannabidiol (Epidiolex), fenfluramine (Fintepla) and stiripentol (Diacomit), which treat seizures but not the underlying genetic cause 1. Direct competition from a disease-modifying medicine does not yet exist, which could be an advantage if zorevunersen is approved, although clinicians also use combinations of several anti-seizure medicines 1.

    The company also mentions other routes to treating rare genetic diseases, such as ASO therapies developed by companies like Sarepta and Biogen, which the management team has been involved with in the past 1. A competitive risk is that an alternative treatment could be approved sooner or be better accepted, and this cannot be ruled out 1.

    • BiogenBIIB

      licensing partner for zorevunersen outside the U.S., Canada and Mexico, bearing 30% of joint development costs 1

    • Acadia PharmaceuticalsACAD

      collaboration partner for the SYNGAP1 program, with revenue recognized in 2025 12

    • Sarepta TherapeuticsSRPT

      company active in ASO therapies for rare genetic diseases, named in the management biography 1

    • Makers of approved anti-seizure medicines

      producers of cannabidiol, fenfluramine and stiripentol, the approved Dravet treatments that form the current competition 1

    News & filings

    In the press

    SEC filings

    Sources

    1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Stoke Therapeutics, Inc. · 16 Mar 2026
    2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Stoke Therapeutics, Inc. · 03 Aug 2026
    3. [3] Form 8-K, results release (exhibit 99.1) · SEC / Stoke Therapeutics, Inc. · 03 Aug 2026

    Figures computed by olivLaw from SEC filings and closing prices; the qualitative analysis is AI-generated from cited sources. Not investment advice.