Welcome to our dedicated page for Agios Pharmaceuticals SEC filings (Ticker: AGIO), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Agios Pharmaceuticals, Inc. (AGIO) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as a Nasdaq-listed biopharmaceutical issuer. As a Delaware corporation with common stock traded on the Nasdaq Global Select Market, Agios submits current and periodic reports to the U.S. Securities and Exchange Commission that document its financial condition, governance decisions, and material events.
For investors analyzing AGIO, key filings include Form 10-K annual reports and Form 10-Q quarterly reports, which describe the company’s rare disease business, risk factors, research and development spending, and details on commercial-stage activities around products such as PYRUKYND (mitapivat) and AQVESME (mitapivat). Form 8-K current reports capture material developments, including quarterly financial results, stock incentive plan amendments, director elections, regulatory updates, and safety-related communications.
This page also surfaces proxy statements and exhibits referenced in filings, which can provide insight into stock incentive plans, non-employee director compensation, and shareholder voting outcomes. Where applicable, Form 4 and other ownership filings can be used to review insider transactions by directors and officers.
Stock Titan enhances these SEC documents with AI-powered summaries that explain complex sections in plain language, helping users quickly understand what each filing means for Agios’ rare disease strategy, PK activation franchise, and capital allocation. Real-time updates from EDGAR ensure that new AGIO filings appear promptly, while structured access to 10-Ks, 10-Qs, 8-Ks, and ownership reports allows for efficient due diligence on this commercial-stage biopharmaceutical company.
Agios Pharmaceuticals is a commercial-stage biopharma focused on rare hematology, built around the PK activator mitapivat, sold as PYRUKYND® for pyruvate kinase deficiency and AQVESME™ for thalassemia. AQVESME™ received FDA approval in December 2025 for anemia in adults with non‑transfusion‑dependent and transfusion‑dependent alpha- or beta‑thalassemia, with a U.S. launch in January 2026 under a REMS requiring intensive liver monitoring.
For the year ended December 31, 2025, Agios reported a net loss of $412.8 million, compared with net income of $673.7 million in 2024, when results were boosted by a $905.0 million sale of vorasidenib royalty rights and a $200.0 million milestone payment. As of December 31, 2025, accumulated deficit was $561.7 million, and as of February 6, 2026, there were 58,592,172 common shares outstanding.
The company is advancing a pipeline that includes tebapivat for lower‑risk myelodysplastic syndromes and sickle cell disease, AG‑181 for phenylketonuria, and AG‑236 (licensed from Alnylam) for polycythemia vera, alongside extensive global intellectual property. Key risks center on successful commercialization of PYRUKYND® and AQVESME™, clinical and regulatory outcomes for mitapivat and other candidates, dependence on third‑party manufacturers and partners, competition in rare diseases, and the need for additional capital if existing resources prove insufficient.
Agios Pharmaceuticals reported wider losses for 2025 while advancing its rare disease portfolio and launching a new U.S. product. Net loss was $412.8 million, compared with net income of $673.7 million in 2024, when results reflected large one-time gains from its oncology business sale.
Product revenue rose to $54.0 million from $36.5 million, driven by PYRUKYND sales, including $20.0 million worldwide net revenue in the fourth quarter. PYRUKYND U.S. net revenue reached $16.0 million in the quarter, up strongly from both the prior year and prior quarter.
In December 2025, the FDA approved AQVESME as the only medicine to treat anemia in adults with alpha- or beta-thalassemia regardless of transfusion burden, and the drug is now available in the U.S. Cash, cash equivalents and marketable securities were $1.2 billion as of December 31, 2025, which Agios expects will fund the AQVESME launch, potential mitapivat launch in sickle cell disease, and advancement of its pipeline.
Agios Pharmaceuticals received an amended ownership report from Farallon investment entities. The filing shows the Farallon funds together report beneficial ownership of 5,159,505 shares of Agios common stock, representing 8.8% of the outstanding class.
Within this group, Farallon Healthcare Partners Master, L.P. reports 2,928,459 shares, or 5%, and Farallon Partners, L.L.C. reports 5,046,401 shares, or 8.7%. The amendment records governance changes: effective January 1, 2026, Avner A. Husen became a member or manager of the Farallon general partner entities and may be deemed a beneficial owner of the Farallon funds’ shares, while as of December 31, 2025, Richard B. Fried, Rajiv A. Patel and William Seybold ceased those roles and may no longer be deemed beneficial owners. The reporting group files under Rule 13d‑1(c) and certifies the shares are held for investment and not to change or influence control of Agios.
State Street Corporation has disclosed a sizeable passive stake in Agios Pharmaceuticals Inc. common stock. As of 12/31/2025, it beneficially owned 3,108,145 shares, representing 5.3% of the outstanding common stock.
State Street reports no sole voting or dispositive power over these shares, with shared voting power over 2,926,200 shares and shared dispositive power over 3,108,145 shares. The position is held in the ordinary course of business and is not intended to change or influence control of Agios, with ownership spread across several State Street Global Advisors investment adviser subsidiaries.
Agios Pharmaceuticals furnished an update on its plans for 2026. On January 12, 2026, the company issued a press release outlining its anticipated 2026 milestones, timed around its presentation at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026. The press release is provided as Exhibit 99.1 and the conference presentation slides as Exhibit 99.2. This information is furnished under a Regulation FD disclosure and is not treated as filed for liability purposes or automatically incorporated into other securities law filings.
Agios Pharmaceuticals Chief Commercial Officer Tsveta Milanova reported the vesting and related sale of company stock. On January 5, 2026, 8,475 restricted stock units were converted into an equal number of Agios common shares at an exercise price of $0. On the same day, 2,872 of those shares were sold at $27.02 per share to cover tax withholding obligations, under durable automatic sale instructions intended to satisfy Rule 10b5-1(c). After these transactions, Milanova directly held 34,793 shares of Agios common stock.
Agios Pharmaceuticals (AGIO) reported an insider transaction by its Chief Medical Officer. On 11/11/2025, the officer exercised stock options for 2,454 shares at $25.01 per share and sold 2,454 common shares at a weighted average price of $43.78 under a Rule 10b5-1 trading plan.
Following these transactions, the officer beneficially owns 61,727 common shares directly. The option exercised was part of a grant originally awarded on March 1, 2023, with vesting beginning on March 1, 2024 and continuing monthly thereafter.
Agios Pharmaceuticals (AGIO) reported an insider transaction by its Chief Medical Officer, Sarah Gheuens. On 10/30/2025, she exercised 200 stock options at $25.01 per share and sold 200 shares at $43.81 pursuant to a Rule 10b5-1 trading plan. Following these trades, she held 61,727 shares of common stock directly.
The derivative table shows 28,584 stock options beneficially owned after the transaction, with an exercise price of $25.01 and an expiration date of 03/01/2033. The option was originally granted on 03/01/2023 for 44,000 shares, vesting 25% on 03/01/2024 with the remainder vesting in 36 equal monthly installments thereafter.
Agios Pharmaceuticals (AGIO) reported Q3 2025 results. Product revenue reached $12.9 million, up from $9.0 million a year ago, driven by PYRUKYND sales. Operating expenses included $86.8 million in research and development and $41.3 million in selling, general and administrative costs, leading to a net loss of $103.4 million for the quarter.
The company ended the period with $1.3 billion in cash, cash equivalents and marketable securities as of September 30, 2025. PYRUKYND advanced internationally: the Saudi Food and Drug Authority approved the thalassemia indication, and Europe’s CHMP issued a positive opinion. In the U.S., the FDA accepted the sNDA for thalassemia and set a PDUFA goal date of December 7, 2025 following a REMS submission.
For the first nine months of 2025, product revenue was $34.1 million versus $25.8 million in 2024, reflecting continued commercial execution while development spending supports the pipeline.
Agios Pharmaceuticals (AGIO) furnished an 8-K announcing it issued a press release with results for the quarter ended September 30, 2025 and other business highlights. The press release is provided as Exhibit 99.1. The company states this information, including Exhibit 99.1, is furnished and not deemed “filed” for purposes of Section 18 of the Exchange Act, and is not incorporated by reference into other filings except as specifically referenced.