Agios Pharmaceuticals, Inc. filings document the regulatory record of a Delaware, Nasdaq-listed commercial-stage biopharmaceutical company focused on rare diseases and hematology. Its 8-K reports furnish operating results, product revenue updates for PYRUKYND® and AQVESME™, business highlights, investor presentations, and Regulation FD disclosures tied to mitapivat commercialization, clinical programs, and regulatory interactions.
Proxy and current-report filings cover annual-meeting proposals, director elections, board-class structure, committee assignments, stockholder voting matters, and compensatory arrangements for directors. Other disclosures address board appointments, pharmacovigilance communications involving PYRUKYND, exhibit filings, and Inline XBRL cover-page data.
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.
Agios Pharmaceuticals (AGIO) reported an insider transaction by its Chief Medical Officer on 10/27/2025. The officer exercised 3,302 stock options at $25.01 per share and sold 3,302 common shares at a $43.92 weighted average price pursuant to a Rule 10b5-1 trading plan.
Following these transactions, the officer directly beneficially owned 61,727 common shares. The filing also lists 28,784 stock options remaining beneficially owned. The sale price ranged from $43.77 to $44.13, and the reporting person undertakes to provide the detailed breakdown upon request. Footnotes note that ownership includes 456 shares acquired through the employee stock purchase plan and that the exercised option was part of a grant originally awarded on March 1, 2023.