Every material Form 8-K AGIOS PHARMACEUTICALS, INC. has filed with the SEC since June 18, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
Agios Pharmaceuticals reported third quarter 2026 net product revenue of $55.4 million, up from $12.9 million a year earlier, and a net loss of $65.0 million, down from $103.4 million. The FDA extended the review deadline for mitapivat in sickle cell disease by three months, to February 1, 2027, which delays a potential launch in that indication.
Q3 2026 total revenue was $55.4 million versus $12.9 million in Q3 2025; U.S. net revenue was $48.7 million.
Net loss per share was $(1.09) in Q3 2026 compared with $(1.78) in Q3 2025.
The FDA extended the PDUFA goal date for mitapivat in sickle cell disease from November 1, 2026 to February 1, 2027.
Cash, cash equivalents and marketable securities were $907.0 million as of September 30, 2026, versus $1.2 billion at December 31, 2025.
Agios reported second-quarter 2026 total revenue of $44.7 million, up from $12.5 million a year earlier, and a net loss of $100.7 million, down from $112.0 million. The company said the FDA granted Priority Review to its mitapivat sickle cell disease application, with a PDUFA goal date of November 1, 2026, and that cash and marketable securities were $964.8 million at June 30, 2026, for shareholders, higher revenue and a smaller loss were offset in part by higher R&D spending and the decision to stop development of tebapivat.
Total revenue was $44.7 million in Q2 2026, versus $12.5 million in Q2 2025; U.S. net revenue was $40.9 million.
Net loss was $100.7 million, or $1.69 per share, versus $112.0 million, or $1.93 per share, a year earlier.
R&D expenses rose to $100.8 million from $91.9 million, driven mainly by a $25.0 million up-front payment to Oscotec for cevidoplenib.
FDA granted Priority Review to the mitapivat sNDA in sickle cell disease, with a PDUFA goal date of November 1, 2026; Agios will not advance tebapivat in LR-MDS or sickle cell disease.
At its June 18, 2026 annual meeting, Agios stockholders approved an amendment adding 2,000,000 shares to the 2023 Stock Incentive Plan, with the same increase for incentive stock options. Stockholders also re-elected Class I directors Rahul Ballal, Brian Goff and Cynthia Smith, approved the advisory pay vote for named executive officers, and ratified PricewaterhouseCoopers LLP as auditor. The larger share reserve gives the company more shares available for equity awards.
2,000,000 additional shares added to the 2023 Stock Incentive Plan; 43,549,751 votes for and 2,527,678 against the amendment
Class I directors elected for three-year terms expiring at the 2029 annual meeting: Rahul Ballal, Ph.D., Brian Goff and Cynthia Smith
Smith received 31,496,376 votes for and 14,592,704 withheld, the lowest support of the three director nominees
PricewaterhouseCoopers LLP ratified as independent registered public accounting firm, with 48,511,213 votes for
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