Kezar Life Sciences was forced to shut down after the FDA’s four-month delay in a key trial-design meeting arrived too late for its autoimmune hepatitis program. The company said it had reached an agreement with regulators on a clinical trial path in February, but it came after the agency canceled the meeting initially scheduled for last October, leaving the biotech without a clear way to proceed. The shutdown quickly expanded beyond planning: Kezar laid off most of its ~60-person workforce and auctioned lab equipment while selling office furniture, according to the report. The company later said it would be sold, with Aurinia Pharmaceuticals identified as the buyer—though timing and continuation of the drug plan remain uncertain. The case underscores how regulatory process volatility can disproportionately affect small biotechs that depend on sequential financing. CEO Chris Kirk argued that FDA decision-making recently has felt inconsistent, describing the FDA as “stochastic” and warning that this pattern is “definitely not good for the biotech ecosystem as a whole.”