After the FDA delayed a decision for Agios Pharmaceuticals’ sickle cell disease candidate, the biopharma is letting go of more than 35% of its R&D employees.
Agios Pharmaceuticals is axing over 35% of its R&D team in a commercial-focused restructuring that analysts view favorably.
The Massachusetts biopharma expects to incur about $11 million in restructuring charges this year, with savings from the 100-plus workforce reduction expected to be realized in 2027, according to a Thursday release. As of December 2025, Agios employed 539 full-time workers across its organization.
“Cost discipline provides another lever toward profitability,” Truist Securities wrote of Agios in a Thursday morning investor note. Agios now estimates it will turn a profit, excluding irregular or non-recurring costs, in 2028.
As part of the shift, Agios has “right sized” its operating model to align with its next phase of growth, CEO Brian Goff said on an earnings call on Thursday. This strategy is designed to “maximize the mitapivat franchise”—Agios’ oral pyruvate kinase activator that has secured approval in PK deficiency (sold as Pyrukynd) and thalassemia (sold as Aqvesme). Together, the mitapivat franchise earned $55.4 million in global net revenue for the third quarter, up 24% from last quarter and beating analysts’ consensus of $51.9 million.
Agios had been expecting an FDA decision for mitapivat in sickle cell disease by Nov. 1, but the agency pushed back its decision until Feb. 1, 2027, after requesting more information on a potential safety protocol for the drug.
Regulators were assessing whether a Risk Evaluation and Mitigation Strategy (REMS) would be necessary for this indication and considered Agios’ response to its information request a major amendment to the drug application, according to an Oct. 30 release.
Both Pyrukynd and Aqvesme come with liver safety warnings, but only Aqvesme has a formal REMS program based on several liver adverse events occurring in thalassemia clinical testing. No similar hepatocellular injury cases have been observed in sickle cell disease thus far.
After the FDA delay, Agios’ stock sank more than 15% to $29.95 per share. Since then, the biotech’s shares have continued to slide, resting at $28.27 per share in premarket trading Friday.
Agios has maintained that it is launch-ready and will continue its labeling discussions with the FDA as part of the ongoing review.
Analysts were complimentary of Agios’ shift in strategy—which in addition to the workforce cuts includes a focus on two mid- to late-stage rare hematology candidates.
Agios is also open to unlocking value from non-core assets, which include AG-181, an investigational PAH stabilizer in early-stage development for a rare, inherited metabolic disorder called phenylketonuria.
“The R&D headcount reduction reflects a sharper allocation of capital toward commercialization and focused late-stage development,” Leerink Partners wrote in a Friday note to investors.
“We view the changes as consistent with the company’s increasing commercial emphasis and later-stage development priorities,” Leerink added.
As of Sept. 30, the biopharma had $907 million in cash and marketable securities on hand.
