olivLaw · US equity research
Agios Pharmaceuticals, Inc. AGIO
Pharmaceutical Preparations · SIC 2834 · Vertical: Pharmaceutical Preparations (SIC 2834)
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.
The AI analysis may be outdated: new filings came after its sources (see the «AI analysis» section).
At the close of 05 Nov 2026, Agios Pharmaceuticals, Inc. (AGIO) stock was 28.27 USD (−9.91% on the day), with market capitalisation 1.7 bn USD, beta 1.10, 52-week range 22.34–45.49 USD. Latest reported quarter (Q3 2026): revenue of 55.4 m USD (+330.0% YoY), net income of -65.0 m USD, diluted EPS -1.09 USD.
Data as of · AI analysis dated · Source: SEC filings and closing prices, computed by olivLaw.
Price history
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Technical reading
- RSI (14)
- 33.9
- weak (30–45)
- Bollinger (20, 2)
- 27.12 – 40.08
- in the lower half of the band · %B 0.09 · band width 38.6%
- SMA 50 / 200
- 33.37 / 31.75
- mixed trend
- MACD (12, 26, 9)
- -0.59 / 0.20
- 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
| Company | S&P 500 | vs S&P 500 | Vertical median | |
|---|---|---|---|---|
| 1 month | −10.9% | −5.9% | −4.9 pp | — |
| 3 months | −11.5% | −4.6% | −6.9 pp | — |
| 6 months | +2.7% | +0.2% | +2.5 pp | — |
| Year to date | +3.9% | +7.4% | −3.6 pp | — |
| 1 year | −30.2% | +8.2% | −38.4 pp | +13.7% |
| 3 years | +26.1% | +68.4% | −42.3 pp | +15.7% |
| 5 years | −38.1% | +56.5% | −94.7 pp | — |
Price returns, dividends excluded.
Quarterly results
Latest quarter: Q3 2026 · 30 Sept 2026
Quarterly margins
Quarterly statements · USD
| Fiscal year | Q4 '24 | Q1 '25 | Q2 '25 | Q3 '25 | Q4 '25 | Q1 '26 | Q2 '26 | Q3 '26 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 10.7 m | 8.7 m | 12.5 m | 12.9 m | 20.0 m | 20.7 m | 44.7 m | 55.4 m |
| Cost of revenue | 1.3 m | 1.1 m | 1.7 m | 1.7 m | 1.9 m | 1.3 m | 3.0 m | 2.5 m |
| Research & development | 82.8 m | 72.7 m | 91.9 m | 86.8 m | 88.1 m | 81.1 m | 100.8 m | 73.5 m |
| SG&A | 51.7 m | 41.5 m | 45.9 m | 41.3 m | 51.6 m | 48.3 m | 51.5 m | 56.5 m |
| Operating income | -125.0 m | -106.6 m | -127.1 m | -116.9 m | -121.6 m | -110.0 m | -110.6 m | -77.2 m |
| Pre-tax income | -105.4 m | — | — | -103.4 m | -109.1 m | — | — | — |
| Income tax | -8.9 m | — | — | 0 | -1.0 m | — | — | — |
| Net income | -96.5 m | -89.3 m | -112.0 m | -103.4 m | -108.0 m | -99.1 m | -100.7 m | -65.0 m |
| Diluted EPS | -1.64 ≈ | -1.55 | -1.93 | -1.78 | -1.85 ≈ | -1.69 | -1.69 | -1.09 |
| Operating cash flow | -133.2 m | -111.5 m | -77.1 m ≈ | -88.2 m ≈ | -96.2 m | -118.9 m | -57.3 m ≈ | -59.2 m ≈ |
| Capex | 967.0 k | 766.0 k | 875.0 k ≈ | 1.6 m ≈ | 1.1 m | 769.0 k | 1.2 m ≈ | 1.2 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 year | 2018 | 2019 | ⚠ 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|---|
| Revenue | 94.4 m | 117.9 m | 0 | 0 | 14.2 m | 26.8 m | 36.5 m | 54.0 m |
| Revenue YoY | +119.4% | +24.9% | — | unavailable | unavailable | +88.4% | +36.1% | +48.0% |
| Net income | -346.0 m | -411.5 m | -327.4 m | 1.6 bn | -231.8 m | -352.1 m | 673.7 m | -412.8 m |
| Net income YoY | unavailable | unavailable | — | unavailable | −114.4% | unavailable | unavailable | −161.3% |
| Diluted EPS | unavailable | -6.86 | -4.74 | 26.55 | -4.23 | -6.33 | 11.64 | -7.12 |
| Diluted EPS YoY | unavailable | unavailable | — | unavailable | −115.9% | unavailable | unavailable | −161.2% |
| net % | -366.6% | -349.0% | unavailable | unavailable | -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
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Revenue | 0 | 0 | 14.2 m | 26.8 m | 36.5 m | 54.0 m | SEC (XBRL)· 12 Feb 2026verified |
| Cost of revenue | 0 | 0 | 1.7 m | 2.9 m | 4.2 m | 6.3 m | SEC (XBRL)· 12 Feb 2026verified |
| Gross profit | 0 ≈ | 0 ≈ | 12.5 m ≈ | 23.9 m ≈ | 32.3 m ≈ | 47.7 m ≈ | SEC (XBRL)· 12 Feb 2026derived |
| Research & development | 220.8 m | 257.0 m | 279.9 m | 295.5 m | 301.3 m | 339.5 m | SEC (XBRL)· 12 Feb 2026verified |
| SG&A | 115.1 m | 121.4 m | 121.7 m | 119.9 m | 156.8 m | 180.3 m | SEC (XBRL)· 12 Feb 2026verified |
| Operating income | -335.9 m | -378.4 m | -389.0 m | -391.5 m | -425.7 m | -472.1 m | SEC (XBRL)· 12 Feb 2026verified |
| Pre-tax income | -329.3 m | -356.5 m | -231.8 m | -352.1 m | 718.0 m | -413.8 m | SEC (XBRL)· 12 Feb 2026verified |
| Income tax | — | — | 0 | 0 | 44.2 m | -1.0 m | SEC (XBRL)· 12 Feb 2026verified |
| Net income | -327.4 m | 1.6 bn | -231.8 m | -352.1 m | 673.7 m | -412.8 m | SEC (XBRL)· 12 Feb 2026verified |
| Diluted EPS | -4.74 | 26.55 | -4.23 | -6.33 | 11.64 | -7.12 | SEC (XBRL)· 12 Feb 2026verified |
| Weighted average diluted shares | 69.0 m | 60.4 m | 54.8 m | 55.7 m | 57.9 m | 58.0 m | SEC (XBRL)· 12 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Revenue − Cost of revenue.
Balance sheet · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Cash | 127.4 m | 203.1 m | 139.3 m | 88.2 m | 76.2 m | 89.1 m | SEC (XBRL)· 12 Feb 2026verified |
| Inventories | 14.7 m | 0 | 8.5 m | 19.1 m | 27.6 m | 32.9 m | SEC (XBRL)· 12 Feb 2026verified |
| Current assets | 636.7 m | 1.1 bn | 832.8 m | 833.8 m | 965.6 m | 942.1 m | SEC (XBRL)· 12 Feb 2026verified |
| Property, plant & equipment, net | 30.8 m | 28.9 m | 23.0 m | 15.4 m | 11.7 m | 10.8 m | SEC (XBRL)· 12 Feb 2026verified |
| Total assets | 853.0 m | 1.4 bn | 1.2 bn | 937.1 m | 1.7 bn | 1.3 bn | SEC (XBRL)· 12 Feb 2026verified |
| Accounts payable | 17.7 m | 16.7 m | 18.6 m | 9.8 m | 16.6 m | 18.4 m | SEC (XBRL)· 12 Feb 2026verified |
| Current liabilities | 94.4 m | 59.8 m | 62.6 m | 68.0 m | 81.2 m | 82.2 m | SEC (XBRL)· 12 Feb 2026verified |
| Total liabilities | 453.5 m | 145.8 m | 137.9 m | 126.1 m | 122.2 m | 104.1 m | SEC (XBRL)· 12 Feb 2026verified |
| Equity | 399.5 m † | 1.3 bn † | 1.1 bn † | 811.0 m † | 1.5 bn † | 1.2 bn † | SEC (XBRL)· 12 Feb 2026verified |
† equity attributable to the parent's shareholders: in these years the issuer no longer reports the total including non-controlling interests.
Cash flow · USD
| Line | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | Source (latest year) |
|---|---|---|---|---|---|---|---|
| Operating cash flow | -290.8 m | -407.3 m | -309.5 m | -296.1 m | -389.8 m | -373.0 m | SEC (XBRL)· 12 Feb 2026verified |
| Capex | 14.1 m | 5.7 m | 4.9 m | 999.0 k | 1.7 m | 4.3 m | SEC (XBRL)· 12 Feb 2026verified |
| Free cash flow | -304.9 m ≈ | -413.1 m ≈ | -314.4 m ≈ | -297.1 m ≈ | -391.5 m ≈ | -377.3 m ≈ | SEC (XBRL)· 12 Feb 2026derived |
| Investing cash flow | 75.7 m | 1.2 bn | 243.3 m | 239.6 m | 363.4 m | 377.2 m | SEC (XBRL)· 12 Feb 2026verified |
| Financing cash flow | 261.5 m | -765.8 m | 2.4 m | 5.4 m | 14.4 m | 8.7 m | SEC (XBRL)· 12 Feb 2026verified |
≈ computed by olivLaw from the reported lines of the same year: Operating cash flow − Capex.
Computed indicators
Growth
Profitability
Returns
Balance sheet
Liquidity
Cash
Efficiency
Market and valuation
1 indicators that do not apply to the sector.
Valuation
olivLaw classification
- 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
05 Nov 2026Source: olivLaw, closing series
Market cap: 1.7 bn USD
Key indicators
Coverage and freshness
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
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
| Factor | Value | Score | Weight used |
|---|---|---|---|
| ROIC · Quality | unavailable | unavailable | — |
| Net margin · Quality | -264.8% | 16 (vs peers) | 23% |
| FCF conversion · Quality | unavailable | unavailable | — |
| Revenue CAGR 3Y · Growth | 56.0% | 100 (on a fixed band) | 31% |
| EPS CAGR 3Y · Growth | unavailable | unavailable | — |
| Net debt / EBITDA · Balance sheet | unavailable | unavailable | — |
| Interest coverage · Balance sheet | unavailable | unavailable | — |
| Current ratio · Balance sheet | 9.7x | 100 (on a fixed band) | 15% |
| P/E (TTM) · Valuation | unavailable | unavailable | — |
| EV/EBITDA · Valuation | unavailable | unavailable | — |
| FCF yield · Valuation | -19.9% | 0 (on a fixed band) | 31% |
| Shareholder yield (distributions) · Returns | unavailable | unavailable | — |
| Payout ratio (FCF) · Returns | unavailable | unavailable | — |
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· partial16/100 · 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 2026-09-30.
Figures computed from the financial statements: revenue 54.0 m USD in 2025; YoY growth 48.0%; net margin -264.8%; ROE -32.9%.
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: 9.7x
What contradicts it
- Net margin: -264.8%
- FCF yield: -19.9%
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
Price rebased to 100 (monthly, 5 years)
Companies in the vertical
| Market cap | P/E | ROE | Net margin | Revenue YoY | 1A / 3A | |
|---|---|---|---|---|---|---|
| LLYEli Lilly And Company | 1,283.9 bn | 44.3 | 86.1% | 31.9% | +44.7% | +27% / +131% |
| JNJJohnson & Johnson | 655.6 bn | 41.3 | 20.0% | 16.2% | +6.0% | +32% / +76% |
| ONCBeone Medicines Ltd. | 575.0 bn | 640.9 | 18.4% | 13.9% | +40.2% | +14% / +107% |
| ABBVAbbVie Inc. | 509.5 bn | 49.6 | — | 15.7% | +8.6% | +27% / +102% |
| MRKMerck & Co., Inc. | 362.2 bn | 151.2 | 5.1% | 3.6% | +1.3% | +40% / +43% |
| ABTAbbott Laboratories | 196.7 bn | 42.3 | 9.2% | 9.7% | +5.7% | −12% / +9% |
| PFEPfizer Inc | 170.3 bn | 42.6 | 4.4% | 6.3% | −1.6% | +16% / −2% |
| VRTXVertex Pharmaceuticals Inc | 137.5 bn | 34.9 | 20.8% | 30.7% | +8.9% | +25% / +53% |
| BMYBristol-Myers Squibb Company | 129.0 bn | 14.0 | 44.1% | 18.5% | −0.2% | +28% / +28% |
| TEVATeva Pharmaceutical Industries Limited | 48.8 bn | 97.3 | 6.6% | 3.6% | +4.3% | +55% / +325% |
| ZTSZoetis Inc. | 33.4 bn | 13.8 | 57.6% | 26.4% | +2.3% | −36% / −54% |
| ROIVRoivant Sciences Ltd. | 26.5 bn | — | -6.2% | -3,535.0% | −71.6% | +76% / +283% |
| RPRXRoyalty Pharma plc | 26.2 bn | 47.7 | 6.9% | 25.7% | +5.1% | +69% / +150% |
| UTHRUnited Therapeutics Corporation | 24.1 bn | 21.3 | 19.1% | 38.6% | +10.6% | +16% / +136% |
| INSMInsmed Inc | 23.9 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 bn | 7.9 | 126.6% | 52.8% | +65.2% | −65% / −7% |
| BBIOBridgeBio Pharma, Inc. | 14.5 bn | — | — | -61.3% | +126.3% | +3% / +159% |
| MDGLMadrigal Pharmaceuticals, Inc. | 9.3 bn | — | -24.8% | -10.9% | +432.1% | −33% / +97% |
| OGNOrganon & Co. | 3.6 bn | 18.0 | 20.3% | 3.5% | −2.9% | +79% / +22% |
| ZLABZai Lab Limited | 2.0 bn | — | -30.0% | -44.9% | +15.3% | +11% / −17% |
| AGIOAgios Pharmaceuticals, Inc. | 1.7 bn | — | -32.9% | -264.8% | +48.0% | −30% / +26% |
| SLSSELLAS Life Sciences Group, Inc. | 1.6 bn | — | -39.6% | — | −100.0% | +386% / +658% |
| OMEROmeros Corp | 1.2 bn | 9.9 | — | — | −34.0% | +76% / +679% |
| IRWDIronwood Pharmaceuticals Inc | 667.2 m | 4.5 | — | 37.4% | −15.7% | +15% / −59% |
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.
Estimated price (USD)
| Estimated price | Bear | Base | Bull |
|---|---|---|---|
| 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 |
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 30 Jul 2026; since then the company filed 8-K (05 Nov 2026 · results), 10-Q (05 Nov 2026).
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.
Possibly outdated: the newest document it read is from 30 Jul 2026; since then the company filed 8-K (05 Nov 2026 · results), 10-Q (05 Nov 2026).
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.
Links, dependencies and risks
Who the company is tied to, from its own SEC filings (customers, suppliers, production, partners, competitors, countries, regulation), from the 5 %+ holders' statements (13D/13G) and from what other companies say about it. Click a node for its evidence; on a listed company the graph moves to it.
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News & filings
In the press
- Insula exilaților a devenit miracolul verde al Greciei. Cum a scăpat Agios Efstratios de dictatura petrolului în doar 10 luniMediafax · 12 Oct 2026 · RO
The latest news item in our archive is from 12 Oct 2026; the newest SEC filing is from 05 Nov 2026. The press archive comes from the RSS feeds we follow and does not necessarily cover the latest event — the filings alongside do.
SEC filings
- Quarterly report05 Nov 2026
- Current report05 Nov 2026Results of operations · Financial statements and exhibits
- Quarterly report30 Jul 2026
- Current report30 Jul 2026Results of operations · Financial statements and exhibits
- Current report18 Jun 2026Departure or appointment of officers · Shareholder vote · Financial statements and exhibits
- Quarterly report29 Apr 2026
- Current report29 Apr 2026Results of operations · Financial statements and exhibits
- Proxy statement24 Apr 2026
- Annual report12 Feb 2026
- Current report12 Feb 2026Results of operations · Financial statements and exhibits
Sources
- [1] Form 10-K, fiscal year ended 2025-12-31 · SEC / Agios Pharmaceuticals, Inc. · 12 Feb 2026
- [2] Form 10-Q, quarter ended 2026-06-30 · SEC / Agios Pharmaceuticals, Inc. · 30 Jul 2026
- [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.