Every 8-K that Agios Pharmaceuticals, Inc. (AGIO) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow AGIO and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full AGIO filings page.
Agios Pharmaceuticals reported second-quarter 2026 results highlighted by sharp growth in mitapivat revenue. Worldwide net revenues from PYRUKYND and AQVESME were $44.7 million, up from $12.5 million a year earlier. Net loss was $100.7 million, compared to $112.0 million, or $1.69 per share.
U.S. mitapivat revenue reached $40.9 million and ex-U.S. revenue $3.8 million, with 442 cumulative AQVESME prescriptions for thalassemia written by REMS‑certified U.S. physicians. PYRUKYND received European Commission marketing authorization for thalassemia, and mitapivat is now approved for adults with thalassemia in the U.S., Saudi Arabia, United Arab Emirates, and EU.
The FDA accepted Agios’ sNDA for mitapivat in sickle cell disease with Priority Review and a November 1, 2026 PDUFA goal date, and the first patient was dosed in the REIGNITE Phase 3 trial. Agios licensed cevidoplenib for immune thrombocytopenia, advanced AG‑236 toward Phase 2/3 in polycythemia vera and AG‑181 in PKU, discontinued tebapivat programs, and ended the quarter with $964.8 million in cash, cash equivalents and marketable securities.
Agios Pharmaceuticals, Inc. reported that stockholders approved an amendment to its 2023 Stock Incentive Plan at the 2026 annual meeting. The amendment increases the number of shares of common stock available for issuance under the plan by 2,000,000 shares and raises the limit for incentive stock options by the same amount.
Stockholders also elected directors, including Rahul Ballal, Ph.D., Brian Goff and Cynthia Smith, and approved additional proposals, with support levels reflected in detailed vote tallies such as 48,511,213 votes for one item versus 116,938 against and 15,376 abstaining.
Agios Pharmaceuticals reported first quarter 2026 results showing rapid growth in its rare disease franchise but continued investment-driven losses. Mitapivat (PYRUKYND® and AQVESME™) generated worldwide net revenues of $20.7 million, up from $8.7 million in the first quarter of 2025, supported by a strong U.S. launch of AQVESME in thalassemia with 242 prescriptions written as of March 31, 2026.
Net loss for the quarter was $99.1 million compared to $89.3 million a year earlier, reflecting higher R&D spending of $81.1 million and SG&A expenses of $48.3 million. Cash, cash equivalents and marketable securities totaled $1.0 billion as of March 31, 2026. The company plans to submit a supplemental NDA for mitapivat in sickle cell disease in the second quarter of 2026 and expects Phase 2 tebapivat readouts in myelodysplastic syndromes and sickle cell disease later in 2026.
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 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 (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, Inc. (Nasdaq: AGIO) filed an 8-K announcing the election of Jay Backstrom, M.D., MPH, to its Board of Directors. The Board approved his appointment on 3 July 2025, effective 8 July 2025, as a Class III director serving until the 2028 annual meeting.
Compensation package under the non-employee director policy:
- Annual cash retainers: $50,000 for board service and $7,500 for Science & Technology Committee duties.
- Equity awards effective 8 July 2025: (i) non-statutory stock option with a Black-Scholes grant-date value of $472,500; (ii) restricted stock units valued at $157,500. The option strike price equals the closing market price on the grant date. Vesting: 25 % of options after one year, remainder monthly over 36 months; RSUs vest one-third annually over three years.
- Standard reimbursement of reasonable travel expenses.
Dr. Backstrom will also sign the company’s standard indemnification agreement. The filing states there are no related-party transactions or other arrangements connected to his selection.
The disclosure is limited to governance matters; it does not include financial results or operational updates.