Gilead places CAR-T program on partial hold after ICANS cases; Agios delays PDUFA submission

Gilead announced a partial clinical hold on its CAR-T therapy after several patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS).

The hold will pause enrollment and dosing while the company evaluates safety data and works with regulators to address the events.

Agios Therapeutics reported that the FDA has pushed back its PDUFA target date, delaying the expected review timeline for its investigational product.

The postponement reflects the agency’s request for additional data, extending the timeline for potential approval.

These developments underscore ongoing regulatory scrutiny in the biotech sector, potentially affecting investor sentiment and development schedules.