STAT+: How a four-month FDA delay forced a small biotech company to close its doors
Why it matters: A four-month FDA delay forced Kezar Life Sciences to lay off 60 staff and sell its assets.
- Kezar Life Sciences reached an agreement with the FDA for a clinical trial for its autoimmune hepatitis treatment, but the breakthrough came four months after an initial meeting was abruptly canceled.
- The FDA's unexplained cancellation of a critical October meeting left Kezar without a clear path forward, leading investors to pull out and forcing the company to lay off most of its 60 staff and auction equipment.
- CEO Chris Kirk views the FDA's actions as part of a concerning trend of "stochastic and maybe even capricious" decision-making, contrasting sharply with the agency's historical consistency and negatively impacting the biotech ecosystem and patients.
A four-month delay by the FDA in scheduling a critical meeting forced small biotech company Kezar Life Sciences to close its doors and sell off its assets, despite eventually reaching an agreement for a clinical trial for its autoimmune hepatitis treatment. CEO Chris Kirk attributes the delay to an alarming pattern of inconsistency and volatility at the FDA, disproportionately impacting smaller drugmakers reliant on timely regulatory clarity.
