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olivLaw · US equity research

Agios Pharmaceuticals, Inc. AGIO

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

31.38USD+0.58% · 1 dayClose 04 Nov 2026

Agios Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare hematologic diseases, whose lead product mitapivat activates the PK enzyme and is marketed as AQVESME in the United States and as PYRUKYND in several other jurisdictions. Quarterly revenue rose sharply in the second quarter of 2026 as the AQVESME launch in thalassemia gained traction, while the company reported cash, cash equivalents and marketable securities of of 964.8 million USD, which could support its launches and pipeline if adoption continues.

At the close of 04 Nov 2026, Agios Pharmaceuticals, Inc. (AGIO) stock was 31.38 USD (+0.58% on the day), with market capitalisation 1.9 bn USD, beta 1.06, 52-week range 22.34–45.49 USD. Latest reported quarter (Q2 2026): revenue of 44.7 m USD (+259.3% YoY), net income of -100.7 m USD, diluted EPS -1.69 USD.

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

Market cap
1.9 bn USD
shares as of 24 Jul 2026
P/E (TTM)
unavailable
Diluted EPS TTM -7.01 · TTM to 30 Jun 2026
E/P (TTM)
-22.34%
TTM to 30 Jun 2026
Dividend yield
unavailable
Beta (2y)
1.06
Volatility (1y) 94%
52-week range
22.3445.49

Price history

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Technical reading

RSI (14)
41.6
weak (30–45)
Bollinger (20, 2)
27.72 – 39.84
in the lower half of the band · %B 0.30 · band width 35.9%
SMA 50 / 200
33.48 / 31.74
mixed trend
MACD (12, 26, 9)
-0.18 / 0.39
MACD below 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+0.4%−1.1%+1.5 pp—
3 months−1.1%−0.5%−0.6 pp—
6 months+16.3%+4.4%+11.9 pp—
Year to date+15.3%+12.3%+3.0 pp—
1 year−21.6%+13.5%−35.1 pp+19.3%
3 years+39.5%+76.4%−36.9 pp+13.0%
5 years−31.3%+63.7%−95.0 pp—
Max drawdown (1y)
−50.9%
18 Nov 2025 → 19 Nov 2025
Max drawdown (5y)
−63.8%
06 Dec 2024 → 19 Nov 2025
Compound annual growth (5y)
−7.2%
S&P 500 +10.4%

Price returns, dividends excluded.

Quarterly results

Latest quarter: Q2 2026 · 30 Jun 2026

Revenue
44.7 m USD
+259.3% YoY
Net income
-100.7 m USD
unavailable YoY
Diluted EPS
-1.69
unavailable YoY
net / operating
-225.1% / -247.1%

Quarterly margins

Quarterly statements · USD

Fiscal yearQ3 '24Q4 '24Q1 '25Q2 '25Q3 '25Q4 '25Q1 '26Q2 '26
Revenue9.0 m10.7 m8.7 m12.5 m12.9 m20.0 m20.7 m44.7 m
Cost of revenue783.0 k1.3 m1.1 m1.7 m1.7 m1.9 m1.3 m3.0 m
Research & development72.5 m82.8 m72.7 m91.9 m86.8 m88.1 m81.1 m100.8 m
SG&A38.5 m51.7 m41.5 m45.9 m41.3 m51.6 m48.3 m51.5 m
Operating income-102.8 m-125.0 m-106.6 m-127.1 m-116.9 m-121.6 m-110.0 m-110.6 m
Pre-tax income1.0 bn-105.4 m——-103.4 m-109.1 m——
Income tax53.1 m-8.9 m——0-1.0 m——
Net income947.9 m-96.5 m-89.3 m-112.0 m-103.4 m-108.0 m-99.1 m-100.7 m
Diluted EPS16.22-1.64 ≈-1.55-1.93-1.78-1.85 ≈-1.69-1.69
Operating cash flow-84.2 m ≈-133.2 m-111.5 m-77.1 m ≈-88.2 m ≈-96.2 m-118.9 m-57.3 m ≈
Capex419.0 k ≈967.0 k766.0 k875.0 k ≈1.6 m ≈1.1 m769.0 k1.2 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 year20182019⚠ 202020212022202320242025
Revenue94.4 m117.9 m0014.2 m26.8 m36.5 m54.0 m
Revenue YoY+119.4%+24.9%—unavailableunavailable+88.4%+36.1%+48.0%
Net income-346.0 m-411.5 m-327.4 m1.6 bn-231.8 m-352.1 m673.7 m-412.8 m
Net income YoYunavailableunavailable—unavailable−114.4%unavailableunavailable−161.3%
Diluted EPSunavailable-6.86-4.7426.55-4.23-6.3311.64-7.12
Diluted EPS YoYunavailableunavailable—unavailable−115.9%unavailableunavailable−161.2%
net %-366.6%-349.0%unavailableunavailable-1,627.8%-1,312.6%1,845.9%-764.0%
Free cash flow-311.4 m-382.7 m-304.9 m-413.1 m-314.4 m-297.1 m-391.5 m-377.3 m

The series breaks before 2020: earlier years come from the original reports of the issuer of that time, later years from a subsequent filing that restated the perimeter (a separation, discontinued operations). The year-on-year change across the break is not shown.

Reported results vs expectations

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Balance sheet & financial health

Fiscal year 2025 · 31 Dec 2025

Cash
89.1 m USD
Financial debt
unavailable USD
Net debt
unavailable USD
Equity
1.2 bn USD
Total assets
1.3 bn USD
Debt / equity
unavailable
Current ratio
11.46x
ROE
-30.2%
ROA
-27.9%
FCF margin
-698.3%

Financial statements (source on every figure)

Revenue and net income (USD)

Margins

Income statement · USD

Revenue
2023
26.8 m
2024
36.5 m
2025
54.0 m

SEC (XBRL)· 12 Feb 2026verified

Cost of revenue
2023
2.9 m
2024
4.2 m
2025
6.3 m

SEC (XBRL)· 12 Feb 2026verified

Gross profit
2023
23.9 m ≈
2024
32.3 m ≈
2025
47.7 m ≈

SEC (XBRL)· 12 Feb 2026derived

Research & development
2023
295.5 m
2024
301.3 m
2025
339.5 m

SEC (XBRL)· 12 Feb 2026verified

SG&A
2023
119.9 m
2024
156.8 m
2025
180.3 m

SEC (XBRL)· 12 Feb 2026verified

Operating income
2023
-391.5 m
2024
-425.7 m
2025
-472.1 m

SEC (XBRL)· 12 Feb 2026verified

Pre-tax income
2023
-352.1 m
2024
718.0 m
2025
-413.8 m

SEC (XBRL)· 12 Feb 2026verified

Income tax
2023
0
2024
44.2 m
2025
-1.0 m

SEC (XBRL)· 12 Feb 2026verified

Net income
2023
-352.1 m
2024
673.7 m
2025
-412.8 m

SEC (XBRL)· 12 Feb 2026verified

Diluted EPS
2023
-6.33
2024
11.64
2025
-7.12

SEC (XBRL)· 12 Feb 2026verified

Weighted average diluted shares
2023
55.7 m
2024
57.9 m
2025
58.0 m

SEC (XBRL)· 12 Feb 2026verified

Balance sheet · USD

Cash
2023
88.2 m
2024
76.2 m
2025
89.1 m

SEC (XBRL)· 12 Feb 2026verified

Inventories
2023
19.1 m
2024
27.6 m
2025
32.9 m

SEC (XBRL)· 12 Feb 2026verified

Current assets
2023
833.8 m
2024
965.6 m
2025
942.1 m

SEC (XBRL)· 12 Feb 2026verified

Property, plant & equipment, net
2023
15.4 m
2024
11.7 m
2025
10.8 m

SEC (XBRL)· 12 Feb 2026verified

Total assets
2023
937.1 m
2024
1.7 bn
2025
1.3 bn

SEC (XBRL)· 12 Feb 2026verified

Accounts payable
2023
9.8 m
2024
16.6 m
2025
18.4 m

SEC (XBRL)· 12 Feb 2026verified

Current liabilities
2023
68.0 m
2024
81.2 m
2025
82.2 m

SEC (XBRL)· 12 Feb 2026verified

Total liabilities
2023
126.1 m
2024
122.2 m
2025
104.1 m

SEC (XBRL)· 12 Feb 2026verified

Equity
2023
811.0 m †
2024
1.5 bn †
2025
1.2 bn †

SEC (XBRL)· 12 Feb 2026verified

Cash flow · USD

Operating cash flow
2023
-296.1 m
2024
-389.8 m
2025
-373.0 m

SEC (XBRL)· 12 Feb 2026verified

Capex
2023
999.0 k
2024
1.7 m
2025
4.3 m

SEC (XBRL)· 12 Feb 2026verified

Free cash flow
2023
-297.1 m ≈
2024
-391.5 m ≈
2025
-377.3 m ≈

SEC (XBRL)· 12 Feb 2026derived

Investing cash flow
2023
239.6 m
2024
363.4 m
2025
377.2 m

SEC (XBRL)· 12 Feb 2026verified

Financing cash flow
2023
5.4 m
2024
14.4 m
2025
8.7 m

SEC (XBRL)· 12 Feb 2026verified

Computed indicators

Growth

Revenue growth (YoY)
48.0%
computed by olivLawFY 2025
Revenue CAGR 3Y
56.0%
computed by olivLawFY 2022 → FY 2025
Revenue CAGR 5Y
unavailable
the base of the ratio is not positive
EBIT growth (YoY)
unavailable
the base of the ratio is not positive
Net income growth (YoY)
-161.3%
computed by olivLawFY 2025
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)
-161.2%
computed by olivLawFY 2025
EPS CAGR 3Y
unavailable
the base of the ratio is not positive
EPS CAGR 5Y
unavailable
the base of the ratio is not positive
FCF growth (YoY)
unavailable
the base of the ratio is not positive

Profitability

Gross margin
92.0%
computed by olivLawTTM to 30 Jun 2026
EBITDA margin
unavailable
input data missing
EBIT margin
-466.8%
computed by olivLawTTM to 30 Jun 2026
Net margin
-418.2%
computed by olivLawTTM to 30 Jun 2026
FCF margin
-371.4%
computed by olivLawTTM to 30 Jun 2026

Returns

ROE
-34.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROA
-31.9%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
ROIC
unavailable
input data missing
ROCE
-44.2%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 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
unavailable
input data missing

Liquidity

Current ratio
10.2x
computed by olivLawbalance sheet at 30 Jun 2026
Quick ratio
9.7x
computed by olivLawbalance sheet at 30 Jun 2026
Cash ratio
1.4x
computed by olivLawbalance sheet at 30 Jun 2026

Cash

Operating cash flow
-360.6 m USD
computed by olivLawTTM to 30 Jun 2026
Capital expenditure
4.7 m USD
computed by olivLawTTM to 30 Jun 2026
Free cash flow
-365.3 m USD
computed by olivLawTTM to 30 Jun 2026
FCF conversion
unavailable
insufficient data
Cash conversion
unavailable
input data missing

Efficiency

Days sales outstanding
unavailable
input data missing
Days inventory outstanding
1,544 days
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Days payables outstanding
785 days
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Cash conversion cycle
unavailable
input data missing

Market and valuation

Market capitalisation
1.9 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
Enterprise value
unavailable
input data missing
Market cap / net income TTM
unavailable
insufficient data
P/E (TTM)
unavailable
insufficient data
Earnings yield
-22.3%
computed by olivLawTTM to 30 Jun 2026
P/B
1.8x
computed by olivLawbalance sheet at 30 Jun 2026
P/S
19.1x
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 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
-19.5%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 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: 4 of at least 6
  • score weight coverage: 27.1% of at least 60%
  • valuation methods computed: 0 of at least 1

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

Closing price

31.38 USD

04 Nov 2026Source: olivLaw, closing series

Market cap: 1.9 bn USD

Key indicators

Market capitalisation
1.9 bn USD
computed by olivLawbalance sheet at 30 Jun 2026
P/E (TTM)
unavailable
insufficient data
P/B
1.8x
computed by olivLawbalance sheet at 30 Jun 2026
EV/EBITDA
unavailable
input data missing
ROE
-34.3%
computed by olivLawTTM to 30 Jun 2026 · balance sheet at 30 Jun 2026
Net margin
-418.2%
computed by olivLawTTM to 30 Jun 2026
Revenue growth (YoY)
48.0%
computed by olivLawFY 2025
Dividend yield
unavailable
no dividend in the structured statements; a missing line is not a confirmed zero

Coverage and freshness

25/37 reporting lines present
Latest full fiscal year: 2025
Latest reported period: 30 Jun 2026
Latest balance sheet date: 30 Jun 2026
Share count (cover of the latest filing), as of: 24 Jul 2026
Source: SEC (XBRL)published 30 Jul 2026
verified 1538derived 113

Score by group

27% · 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 · input data missing
  • 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: 4 of at least 6; score weight coverage: 27.1% of at least 60%; valuation methods computed: 0 of at least 1

FactorValueScoreWeight used
ROIC · Qualityunavailableunavailable—
Net margin · Quality-418.2%18 (vs peers)23%
FCF conversion · Qualityunavailableunavailable—
Revenue CAGR 3Y · Growth56.0%100 (on a fixed band)31%
EPS CAGR 3Y · Growthunavailableunavailable—
Net debt / EBITDA · Balance sheetunavailableunavailable—
Interest coverage · Balance sheetunavailableunavailable—
Current ratio · Balance sheet10.2x100 (on a fixed band)15%
P/E (TTM) · Valuationunavailableunavailable—
EV/EBITDA · Valuationunavailableunavailable—
FCF yield · Valuation-19.5%0 (on a fixed band)31%
Shareholder yield (distributions) · Returnsunavailableunavailable—
Payout ratio (FCF) · Returnsunavailableunavailable—

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

Score groups

  • Balance sheet· partial100/100 · 1/3 factors with a value
  • Growth· partial100/100 · 1/2 factors with a value
  • Quality· partial18/100 · 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

AGIOS PHARMACEUTICALS, INC. (AGIO). Latest full fiscal year: 2025; data up to 2026-06-30.

Figures computed from the financial statements: revenue 54.0 m USD in 2025; YoY growth 48.0%; net margin -418.2%; ROE -34.3%.

Valuation cannot be computed from the available data.

Insufficient data for a verdict (indicators available: 4 of at least 6; score weight coverage: 27.1% 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: 56.0%
  • Current ratio: 10.2x

What contradicts it

  • Net margin: -418.2%
  • FCF yield: -19.5%

Not assessed (insufficient data or a ratio without meaning): ROIC, FCF conversion, EPS CAGR 3Y, Net debt / EBITDA, Interest coverage, 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 38.6x
EV/EBITDA
—
vertical median 25.4x
P/S
19.1x
vertical median 7.3x
above median (+161.1%)
P/B
1.8x
vertical median 6.1x
below median (−69.8%)
ROE
-34.3%
vertical median -9.5%
below median
Net margin
-418.2%
vertical median 3.6%
below median (−11,637.5%)
EBIT margin
-466.8%
vertical median -4.2%
below median
Revenue YoY
48.0%
vertical median 5.9%
above median (+719.9%)
Net debt/EBITDA
—
vertical median -0.0x
Dividend yield
—
vertical median 2.2%

Price rebased to 100 (monthly, 5 years)

Companies in the vertical

Market capP/EROENet marginRevenue YoY1A / 3A
LLYEli Lilly And Company1,334.0 bn46.086.1%31.9%+44.7%+32% / +140%
JNJJohnson & Johnson665.2 bn41.920.0%16.2%+6.0%+34% / +79%
ONCBeone Medicines Ltd.558.4 bn869.914.7%10.7%+40.2%+11% / +102%
ABBVAbbVie Inc.521.1 bn50.7—15.7%+8.6%+29% / +107%
MRKMerck & Co., Inc.370.7 bn154.75.1%3.6%+1.3%+43% / +47%
ABTAbbott Laboratories200.1 bn43.09.2%9.7%+5.7%−10% / +11%
PFEPfizer Inc175.5 bn43.94.4%6.3%−1.6%+20% / +1%
VRTXVertex Pharmaceuticals Inc139.2 bn35.320.8%30.7%+8.9%+27% / +55%
BMYBristol-Myers Squibb Company131.2 bn14.244.1%18.5%−0.2%+30% / +30%
TEVATeva Pharmaceutical Industries Limited48.8 bn97.46.6%3.6%+4.3%+56% / +326%
ZTSZoetis Inc.36.9 bn14.764.4%27.5%+2.3%−30% / −50%
ROIVRoivant Sciences Ltd.27.6 bn—-6.2%-3,535.0%−71.6%+84% / +300%
RPRXRoyalty Pharma plc26.2 bn47.76.9%25.7%+5.1%+69% / +150%
UTHRUnited Therapeutics Corporation25.9 bn23.019.1%38.6%+10.6%+25% / +154%
INSMInsmed Inc24.1 bn—-72.5%-39.9%+66.7%−47% / +340%
VTRSViatris Inc.22.1 bn—-23.6%-23.9%−3.0%+80% / +109%
ALNYAlnylam Pharmaceuticals, Inc.21.6 bn8.1126.6%52.8%+65.2%−64% / −4%
TGTXTg Therapeutics, Inc.9.4 bn22.5100.3%55.2%+87.3%+85% / +381%
BLRXBioLineRx Ltd4.9 bn—-12.8%-171.7%−95.9%−46% / −97%
BHCBausch Health Companies Inc.3.1 bn——-7.6%+6.7%+31% / +17%
AGIOAgios Pharmaceuticals, Inc.1.9 bn—-34.3%-418.2%+48.0%−22% / +40%
ANABAnaptysbio, Inc.1.4 bn11.5—82.4%+157.0%+71% / +404%
KURAKura Oncology, Inc.677.0 m—-167.7%-384.3%+25.2%−37% / −21%
DMACDiaMedica Therapeutics Inc.580.8 m—-114.6%—unavailable+25% / +341%
PHATPhathom Pharmaceuticals, Inc.461.7 m——-30.2%+216.9%−64% / −19%

1- and 3-year price returns: for AGIO 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
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Base
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Bull
Allowed range: -50 … 50%
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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.

    In brief

    Agios Pharmaceuticals is a commercial-stage biopharmaceutical company focused on rare hematologic diseases, whose lead product mitapivat activates the PK enzyme and is marketed as AQVESME in the United States and as PYRUKYND in several other jurisdictions. Quarterly revenue rose sharply in the second quarter of 2026 as the AQVESME launch in thalassemia gained traction, while the company reported cash, cash equivalents and marketable securities of 1 of 964.8 million USD, which could support its launches and pipeline if adoption continues 3.

    SWOT

    Strengths

    • The company has a commercial product approved in several jurisdictions and a mechanism described as clinically validated, giving it experience and specialist relationships 13.
    • Remaining liquidity is described by management as sufficient to fund the commercial launch and clinical programs without an immediate financing need 3.

    Weaknesses

    • The company reports recurring net losses and has not yet reached operating profitability, while expenses rise with commercial launches 13.
    • Revenue depends largely on one product, making results sensitive to the AQVESME launch and reimbursement access 13.
    • Several clinical programs have been stopped, including tebapivat, showing a high risk of failure in early development 3.

    Opportunities

    • A sickle cell disease approval, if granted, could significantly expand the patient base for mitapivat 3.
    • Cevidoplenib could open a new indication in ITP, with potential sales the company describes as material 3.
    • If adoption in Europe continues after recent approvals, ex-U.S. revenue could grow and reduce reliance on the American market 3.

    Threats

    • Competition in thalassemia and sickle cell disease includes established therapies and genetic treatments that could limit mitapivat's share 1.
    • A slower AQVESME uptake or restrictive reimbursement could affect the revenue path, especially if REMS requirements prove burdensome 13.
    • Hepatic risks noted in the product labeling could lead to further restrictions if new adverse events emerge 1.

    Risks

    • Dependence on a single producthigh

      Commercial revenue comes almost entirely from mitapivat, so any manufacturing, safety or market access problem could materially affect results 1.

    • Recurring net losseshigh

      The company reported net losses in 2025 and in the second quarter of 2026, and management does not rule out that profitability may never be achieved 13.

    • Clinical failures in the pipelinemedium

      The discontinuation of tebapivat after Phase 2 studies shows that programs can fail, and those in Phase 2/3 could also produce unfavorable results 3.

    • Liver safety and REMSmedium

      The AQVESME label includes a warning on hepatocellular injury and a REMS requirement, which could slow prescribing or prompt regulatory action 1.

    • Regulatory decision for sickle cell diseasemedium

      Approval in sickle cell disease is not assured, and a negative response or additional requirements could delay an important source of growth 13.

    Investment thesis

    What would need to be true (bull case)

    • If the AQVESME launch sustains the pace of its first full quarter and sickle cell approval is obtained, revenue could rise substantially within a relatively short period 3.
    • Diversification through licenses such as cevidoplenib could open new markets and reduce dependence on a single product 23.
    • Liquidity above 900 million USD could support clinical programs and launches without urgent financing, which could preserve strategic flexibility 3.

    What would break the thesis

    • Repeated net losses show the business is not yet self-sustaining, and if revenue grows more slowly than expenses, liquidity could fall quickly 13.
    • Dependence on mitapivat and the liver-safety risk could limit adoption, particularly if new regulatory restrictions appear 1.
    • Pipeline setbacks such as those for tebapivat show that clinical results can be unfavorable, which could reduce the value of new programs 3.

    What to watch

    • FDA decision on the sNDA in sickle cell disease2026
    • Pace of AQVESME prescriptions and U.S. salesQ3 2026

    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.

    The business

    Agios describes its activity as dedicated to redefining rare disease treatment, with a foundation in hematology and cellular metabolism 1. Its lead product mitapivat is approved in the United States as AQVESME for anemia in thalassemia and as PYRUKYND for hemolytic anemia in PK deficiency, while the European Union, Great Britain and Saudi Arabia have approvals for related indications 13. The company is also pursuing an expanded indication through an sNDA in sickle cell disease, with a PDUFA goal date of November 1, 2026 3.

    Beyond commercial sales, Agios previously recognized income from the sale of its oncology business to Servier and from the sale of vorasidenib royalty rights to Royalty Pharma, which explains the positive net result for 2024 1. In 2025 and the first half of 2026 the company continued to report net losses, and management states it expects significant expenses and losses until it can report profitable results 12.

    Segments

    Mitapivat (PYRUKYND and AQVESME)

    Mitapivat is the only product with significant commercial revenue. U.S. sales reached 40.9 million USD in the second quarter of 2026, driven mainly by the January 2026 launch of AQVESME in thalassemia, while ex-U.S. sales of 3.8 million USD came from Europe and GCC countries 3.

    Market context

    Agios operates in rare hematologic diseases, where patient populations are small: the company estimates PK deficiency at roughly 3,000 to 8,000 individuals in the United States and EU5, and thalassemia and sickle cell disease at considerably larger but still limited numbers 1. The market is marked by unmet need and under-diagnosis, and by a demand for robust clinical evidence to secure reimbursement 1.

    Revenue growth depends on AQVESME adoption in thalassemia, the FDA decision for sickle cell disease and reimbursement access in Europe, where mitapivat now holds approvals in several member states 23.

    Trends

    • AQVESME launch in the United Statestailwind

      Cumulative AQVESME prescriptions reached 442 by June 30, 2026, which points to early adoption, though sustained uptake will depend on physician and patient engagement under a REMS framework 3.

    • FDA decision for sickle cell diseasetailwind

      The sNDA for mitapivat in sickle cell disease received priority review with a PDUFA goal date of November 1, 2026; if approved, the indication could widen the addressable patient base 3.

    • Pipeline setbacksheadwind

      Tebapivat was stopped in lower-risk MDS and sickle cell disease after Phase 2 studies, showing that not all clinical programs will reach the market 3.

    • Rising operating costsmixed

      Research and development and selling costs rose in the second quarter of 2026 and cash declined from year-end 2025, which could limit investment if revenue does not grow enough 23.

    Competitive position

    The documents cited by Agios name competing thalassemia therapies such as Reblozyl, Casgevy and Zynteglo, and for sickle cell disease alternatives such as hydroxyurea, Adakveo, Casgevy and Lyfgenia 1. For lower-risk MDS the competition includes Reblozyl and Rytelo, and for polycythemia vera phlebotomy remains the standard of care 1.

    Agios points to its PK activation mechanism, supported by approvals in several indications, as a potential differentiator, but the sources do not provide a quantitative comparison with competitors, so positioning analysis stays limited to what the filings describe 13.

    • Bristol-Myers Squibb (Reblozyl)BMY

      Reblozyl is named in the filings as an approved treatment for beta-thalassemia and for anemia in lower-risk MDS, making it a direct competitor in those indications 1.

    • Vertex Pharmaceuticals (Casgevy)VRTX

      Casgevy is named in the filings as a treatment for transfusion-dependent beta-thalassemia and sickle cell disease, overlapping with indications targeted by Agios 1.

    • bluebird bio (Zynteglo)

      Zynteglo is named in the filings for transfusion-dependent beta-thalassemia, an alternative therapy for the same patient group 1.

    • Geron (Rytelo)

      Rytelo is named in the filings as an approved treatment for anemia associated with lower-risk MDS, a competitor in that indication 1.

    News & filings

    SEC filings

    Sources

    1. [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Agios Pharmaceuticals, Inc. · 12 Feb 2026
    2. [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Agios Pharmaceuticals, Inc. · 30 Jul 2026
    3. [3] Form 8-K, results release (exhibit 99.1) · SEC / Agios Pharmaceuticals, Inc. · 30 Jul 2026

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