AGIO at a glance
AGIOS PHARMACEUTICALS, INC. (AGIO, SEC CIK 1439222) filed its latest 10-K annual report on February 12, 2026, a 10-Q quarterly report on July 30, 2026, an 8-K current report on July 30, 2026 and Form 4 insider filings as recently as August 6, 2026. SignalX summarizes each filing with AI and tracks the company's insider trades and institutional holders.
- For the fiscal year ended December 31, 2025 (FY2025), AGIOS PHARMACEUTICALS, INC. (AGIO) reported revenue of $54.0 million (up 48.0% from FY2024) and a net loss of $412.8 million. Diluted EPS was -$7.12.
- As of June 30, 2026, 26 institutional investment managers tracked by SignalX reported holding AGIOS PHARMACEUTICALS, INC. (AGIO) shares worth $973.1 million in 13F-HR filings.
- The most recent insider open-market sale reported on Form 4 was by Gheuens Sarah on August 4, 2026 of 30,000 shares at $30.48 per share.
- In the last 90 days, AGIO insiders reported 0 open-market purchases ($0) and 1 open-market sale ($914K) on Form 4, a net sale of $914K.
Source: SEC EDGAR (XBRL financial data, 13F-HR and Form 4 filings).
- Revenue · FY2025
- $54.0M
- +48.0% vs prior year
- Insiders · 90 days
- 0 buys · 1 sell
- Net −$914K
- 13F holders
- 26 funds
- $973.1M · −1 vs prior quarter
- Latest 8-K
- Jul 30, 2026
- Item 2.02
AI 10-K Annual Report Analysis
Latest 10-K, fiscal year ended Dec 31, 2025
Business Overview
- Core business: Commercial-stage biopharma focused on rare hematology diseases via PK activator small molecules
- New regulatory approvals for mitapivat: FDA approval of AQVESME™ for thalassemia anemia (Dec 2025), Saudi Arabia approval for PYRUKYND®, EMA positive opinion pending final decision early 2026
- Strategic shift: Divested oncology business in 2021, monetized vorasidenib milestone and royalty rights for total $1.1B cash inflow by 2024
- R&D investment milestone: $10M milestone payment to Alnylam in 2025 under license for siRNA candidate AG-236 in polycythemia vera
- Noteworthy metric: Completed phase 3 SCD trial with mitapivat, 40.6% hemoglobin response vs 2.9% placebo, launched U.S. commercial thalassemia product in Jan 2026
Risk Factors
- Regulatory risk: FDA REMS requirements for AQVESME™ due to boxed warning on hepatocellular injury risk
- Macroeconomic risk: geopolitical events like war impacting patient enrollment and clinical trial site operations internationally
- Supply chain risk: reliance on third-party CROs and contractors with limited control over compliance and timelines
- Market disruption risk: competition for patient enrollment from other companies’ clinical trials in same indications
- Financial risk: $130M potential milestone and royalty payments under license agreement with Alnylam for siRNA candidate targeting TMPRSS6
Management Discussion & Analysis
- Revenue from PYRUKYND® and AQVESME™ product sales began in 2022 and 2026 respectively; milestone income $200M in 2024 from Vorasidenib FDA approval
- Net income $673.7M in 2024 driven by $1.09B total gain from Vorasidenib royalty rights sale and milestone payment, net loss $412.8M in 2025, net loss $352.1M in 2023
- Best segment: Oncology contingent payments, $889.1M gain in 2024 from contingent payments sale; Worst segment: ongoing R&D and commercialization expenses driving net losses in 2025
- Cash inflows include $905M from sale of Vorasidenib Royalty Rights in 2024; R&D expenses include $17.5M upfront license payment plus $10M milestone payment to Alnylam in 2025
- Future outlook: FDA pre-sNDA meeting Q1 2026 for mitapivat in sickle cell disease; EU approval expected early 2026; continued investment in clinical trials and commercialization expansion
AI summary of the AGIO 10-K filed . Generated from the filing text; verify against the original.View on SEC EDGARHow to read a 10-K
AI 10-Q Quarterly Report Analysis
Latest 10-Q, quarter ended Jun 30, 2026
Risk Factors
- Newly triggered commercialization risk: AQVESME™ U.S. launch in late January 2026 introduced REMS-related prescribing and patient-access constraints
- Regulatory safety risk: AQVESME™ carries an FDA boxed warning for potential hepatocellular injury and requires an approved REMS
- Operational risk: Limited eligible populations and competitor trials could delay enrollment in genetically or biomarker-defined studies
- Competitive risk: Competing products approved for the same indications could reduce PYRUKYND® and AQVESME™ market acceptance
- Financial risk: Oscotec license adds up to $140.0 million in potential development and regulatory milestones plus royalties
AI summary of the AGIO 10-Q filed . Generated from the filing text; verify against the original.View on SEC EDGAR10-K vs 10-Q vs 8-K
AI 8-K Current Report Analysis
The most recent material events, by 8-K item
Item EX-99.1: Item EX-99.1
- Q2 2026 mitapivat revenue $44.7M, up from $12.5M, indicating accelerating commercial adoption
- AQVESME launch generated 442 cumulative U.S. thalassemia prescriptions by June 30, 2026
Item 2.02: Results of Operations and Financial Condition
- Q2 2026 results for quarter ended June 30, 2026, with business highlights issued July 30, 2026
- Detailed financial results and operating updates contained in Exhibit 99.1 press release
Item 5.02: Departure/Appointment of Directors or Principal Officers
- Stockholders approved 2,000,000 additional shares under Agios’s 2023 Stock Incentive Plan
- Incentive stock-option capacity also increased by 2,000,000 shares
Item 5.07: Submission of Matters to a Vote of Security Holders
- Rahul Ballal, Brian Goff and Cynthia Smith elected as Class I directors through 2029
- Cynthia Smith faced 14,592,704 withheld votes, indicating comparatively weaker shareholder support
Item 2.02: Results of Operations and Financial Condition
- Q1 2026 results for quarter ended March 31, 2026, with business highlights
- Full financial details and management commentary in Exhibit 99.1 press release
Item EX-99.1: Item EX-99.1
- Q1 2026 product revenue $20.7M, up from $8.7M, signaling accelerating mitapivat commercialization
- AQVESME launch produced 242 thalassemia prescriptions by March 31, establishing early U.S. demand momentum
AI summaries of AGIO 8-K current reports filed with the SEC. What 8-K item codes mean
SignalX for AGIO
Don't miss the next AGIO filing
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- Fund moves. Which tracked funds opened, added or cut AGIO, by share count.
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Recent Insider Transactions (Form 4)
Latest reported trades by officers, directors and 10% owners
| Insider | Type | Date | Shares | Price |
|---|---|---|---|---|
| Gheuens Sarah | Sell | Aug 4, 2026 | 30,000 | $30.48 |
| Backstrom Jay T. | M | Jul 8, 2026 | 1,447 | - |
| Backstrom Jay T. | A | Jul 8, 2026 | 1,447 | - |
| Gheuens Sarah | Sell | Jul 1, 2026 | 4,007 | $37.56 |
| Gheuens Sarah | M | Jul 1, 2026 | 8,375 | - |
| Gheuens Sarah | M | Jul 1, 2026 | 8,375 | - |
| FOUSE JACQUALYN A | M | Jun 18, 2026 | 2,816 | - |
| CAPELLO JEFFREY D | A | Jun 18, 2026 | 14,950 | - |
Financial SummaryXBRL
| Metric | FY2023 | FY2024 | FY2025 |
|---|---|---|---|
| Profitability | |||
| Revenue | - | $36.5M | $54.0M |
| Operating Income | - | -$425.7M | -$472.1M |
| Net Income | -$352.1M | $673.7M | -$412.8M |
| Op. Margin | - | -1166.5% | -873.9% |
| Net Margin | - | 1845.9% | -764.0% |
| Balance Sheet | |||
| Total Assets | - | $1.7B | $1.3B |
| Equity | $811.0M | $1.5B | $1.2B |
| ROE | -43.4% | 43.7% | -34.6% |
| Per Share | |||
| EPS | $-6.33 | $11.64 | $-7.12 |
| Cash Flow | |||
| Operating CF | - | -$389.8M | -$373.0M |
| CapEx | $999K | $1.7M | $4.3M |
Source: XBRL data in AGIOS PHARMACEUTICALS, INC. (AGIO)'s 10-K filings on SEC EDGAR, in USD. Compare across companies →
13F Fund Holdings: Quarterly Trend
Latest: Q2 2026Aggregate AGIO share value held by 13F filers tracked by SignalX, by quarter.
Quarterly totals table
| Quarter | Funds | Total value |
|---|---|---|
| Q2 2026 | 26 | $973.1M |
| Q1 2026 | 27 | $770.1M |
| Q4 2025 | 24 | $644.9M |
| Q3 2025 | 25 | $808.4M |
| Q2 2025 | 25 | $744.6M |
| Q1 2025 | 21 | $451.4M |
| Q4 2024 | 18 | $410.5M |
| Q3 2024 | 15 | $259.8M |
- BlackRock+701.0K (+12%)
- AQR Capital Management+647.9K (+1780%)
- D.E. Shaw & Co+425.8K (+16%)
- Goldman Sachs Group+345.2K (+43%)
- Vanguard Portfolio Management LLC+287.2K (+11%)
- T. Rowe Price Group−79.8K (-27%)
- Morgan Stanley−4.3K (-0%)
- Bank of America Corp−31 (-0%)
- Allstate+9.5K
- Millennium Management−32.1K
- Franklin Resources−8.3K
Source: 13F-HR filings on SEC EDGAR (aggregated from 181 fund-quarter rows). Reflects only 13F filers tracked by SignalX, not the full institutional ownership universe. How 13F filings work
AGIO filing archive
AI analysis pages for each 10-K, 10-Q and 8-K
10-K annual reports
10-Q quarterly reports
8-K current reports
Latest 2026 SEC Filings: 10-K, 10-Q, 8-K & Form 4
| Form | Filing date | Period | Analysis | SEC |
|---|---|---|---|---|
| 4 | Aug 6, 2026 | - | - | - |
| 8-K | Jul 30, 2026 | - | Analysis | - |
| 10-Q | Jul 30, 2026 | Jun 30, 2026 | Analysis | |
| 4 | Jul 10, 2026 | - | - | - |
| 4 | Jul 2, 2026 | - | - | - |
| SC 13G | Jul 2, 2026 | - | - | |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 4 | Jun 23, 2026 | - | - | - |
| 8-K | Jun 18, 2026 | - | Analysis | - |
| 4 | Jun 16, 2026 | - | - | - |
| 4 | Jun 16, 2026 | - | - | - |
| SC 13G | May 6, 2026 | - | - |
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AGIO SEC filings: frequently asked questions
Are AGIO insiders buying or selling?
In the last 90 days, AGIOS PHARMACEUTICALS, INC. (AGIO) officers, directors and 10% owners reported no open-market purchases and 1 open-market sale worth $914,400 by 1 insider on Form 4. Many insider sales are pre-planned or for taxes, so purchases usually carry more information.
Which institutions hold AGIO stock?
As of June 30, 2026, the largest AGIOS PHARMACEUTICALS, INC. (AGIO) holders among the 13F filers tracked by SignalX were BlackRock ($239.6 million), State Street Corp ($131.1 million), D.E. Shaw & Co ($115.3 million), Vanguard Portfolio Management LLC ($107.6 million), Vanguard Capital Management LLC ($99.5 million). 13F-HR reports are filed up to 45 days after each quarter ends.
What was AGIO's revenue in fiscal year 2025?
For the fiscal year ended December 31, 2025 (FY2025), AGIOS PHARMACEUTICALS, INC. (AGIO) reported revenue of $54.0 million (up 48.0% from FY2024) and a net loss of $412.8 million. Diluted EPS was -$7.12. The figures come from the XBRL data in the 10-K.
What are the main risks in AGIO's latest 10-K?
In the 10-K filed February 12, 2026, AGIOS PHARMACEUTICALS, INC. (AGIO) flagged: Regulatory risk: FDA REMS requirements for AQVESME™ due to boxed warning on hepatocellular injury risk. Macroeconomic risk: geopolitical events like war impacting patient enrollment and clinical trial site operations internationally. (AI summary of the Risk Factors section.)
What did AGIO report in its latest 8-K?
AGIOS PHARMACEUTICALS, INC. (AGIO) filed an 8-K on July 30, 2026 reporting Item 2.02 (Results of Operations and Financial Condition). Q2 2026 mitapivat revenue $44.7M, up from $12.5M, indicating accelerating commercial adoption.
What are the latest AGIO SEC filings?
AGIOS PHARMACEUTICALS, INC. (AGIO) filed its latest 10-K annual report on February 12, 2026, a 10-Q quarterly report on July 30, 2026, an 8-K current report on July 30, 2026 and a Form 4 insider filing on August 6, 2026.
What is AGIO's SEC CIK number?
AGIOS PHARMACEUTICALS, INC. (AGIO)'s SEC Central Index Key (CIK) is 1439222. EDGAR lists every AGIO filing under that number.
Ask anything about AGIO
The research agent reads AGIO's filings, financials, insider trades and 13F holders, then answers with sources.