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Investing.com - Goldman Sachs has reiterated its Neutral rating and $39.00 price target on Agios Pharmaceuticals (NASDAQ:AGIO), currently trading at $36.13, following the company’s announcement of a three-month delay in its FDA review timeline. According to InvestingPro data, analyst targets range from $37 to $57, suggesting potential upside despite recent challenges.
The delay comes after the FDA requested Agios submit a proposed Risk Evaluation and Mitigation Strategy (REMS) to address potential hepatocellular injury risks, pushing the PDUFA goal date to December 7. According to Goldman Sachs, this requirement was not triggered by new safety or efficacy data. The company maintains strong financial health with a current ratio of 14.48 and holds more cash than debt on its balance sheet, as revealed by InvestingPro analysis.
Agios shares fell 11% on the news as investors expressed concerns about potential impact on drug uptake. The investment firm noted the REMS requirement is currently specific to thalassemia treatment.
Goldman Sachs maintains that Pyrukynd still demonstrates a favorable risk-benefit profile, citing the low incidence rate of hepatocellular injury (less than 1%) and significant reductions in transfusion burden and quality-of-life improvements for patients.
The firm also highlighted potential upside for Agios from upcoming Phase 3 RISE UP trial data in sickle cell disease expected in late 2025, while acknowledging risks to the primary endpoint measuring vaso-occlusive crises, which Goldman Sachs considers critical for commercial success based on key opinion leader feedback.
In other recent news, Agios Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its supplemental New Drug Application for the thalassemia drug PYRUKYND by three months. The new Prescription Drug User Fee Act (PDUFA) date is now set for December 7, 2025. This extension follows Agios’ submission of a Risk Evaluation and Mitigation Strategy to address potential hepatocellular injury risks, which the FDA considered a major amendment. BofA Securities responded to this development by lowering its price target for Agios Pharmaceuticals to $51.00 from $52.00, although it maintained a Buy rating. Meanwhile, TD Cowen reiterated its Buy rating on Agios Pharmaceuticals, addressing safety concerns related to the drug mitapivat. The firm noted that recent FDA Adverse Event Reporting System reports of deaths in patients taking mitapivat do not support a link to the medication. These developments reflect ongoing regulatory and safety evaluations concerning Agios Pharmaceuticals.
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