Agios Cuts Over 100 R&D Roles While FDA Delays Sickle Cell Ruling

Agios Pharmaceuticals says it will have cut more than 100 research and development roles by the end of 2026. The Cambridge, Massachusetts, drugmaker disclosed the cuts with its third quarter results on Nov. 5. It is also waiting on a delayed FDA decision for its drug mitapivat in sickle cell disease.

What happened

Agios said it reviewed its operating model over 2026. By year-end, its R&D headcount will be down by over 100 roles. That is a decrease of more than 35% compared with 2025. The company expects the cost savings to arrive in 2027.

BioSpace reported that Agios expects about $11 million in restructuring charges this year. It also reported that Agios had 539 full-time workers as of December 2025, citing a company filing.

Agios also faces a regulatory delay. The FDA extended its review of mitapivat for sickle cell disease by three months. The goal date moved from Nov. 1, 2026, to Feb. 1, 2027. Agios said the agency asked for more information to judge whether a REMS, a formal drug safety protocol, is needed. The FDA treated the company's reply as a major amendment.

According to BioSpace, Agios shares fell more than 15% to $29.95 after the delay.

Why it matters

Mitapivat is sold as Pyrukynd and Aqvesme. Worldwide net revenue from the drug reached $55.4 million in the third quarter, up from $12.9 million a year earlier. Agios said the quarter alone topped its product revenue for all of 2025.

Sickle cell disease would be a new use for the drug. Agios said it is ready to launch ahead of the new goal date. BioSpace noted that both Pyrukynd and Aqvesme carry liver safety warnings. Only Aqvesme has a formal REMS, based on liver side effects seen in thalassemia trials. BioSpace said no similar cases have been seen in sickle cell so far.

The company had $907.0 million in cash, cash equivalents and marketable securities on Sept. 30. That compares with $1.2 billion at the end of 2025. Agios now aims to reach non-GAAP profitability in 2028.

What it means for people in the industry

The cuts fall on research and development staff. BioSpace reported that the company will focus its pipeline on two mid- to late-stage candidates for rare blood disorders. Chief executive Brian Goff told analysts the company had "right sized" its operating model, BioSpace reported.

Spending is shifting toward sales. Agios said its selling, general and administrative costs rose in the quarter. It tied the rise to the Aqvesme launch and to preparing for a possible US sickle cell launch.

The next marker is the FDA decision, now due by Feb. 1, 2027, and whether it comes with a REMS.

See open pharma jobs in the US and Canada

Sources

• Agios Reports Third Quarter 2026 Financial Results and Provides Business Update, Agios Pharmaceuticals (SEC filing)
• Agios axes 100-plus R&D roles while awaiting FDA decision, BioSpace