FDA cancelation shuts down Kezar, sale to Aurinia
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- Kezar Life Sciences secured a February FDA agreement to a clinical‑trial plan for its autoimmune hepatitis treatment.
- FDA abruptly canceled the October trial‑design meeting without explanation, leaving Kezar unable to proceed.
- Kezar Life Sciences began winding down, laying off most of its ~60 staff and auctioning lab equipment and office furniture.
- Kezar Life Sciences announced a sale to Aurinia Pharmaceuticals, which hopes to continue development of the hepatitis drug, though timing is unclear.
- Chris Kirk, Kezar’s CEO, said the FDA’s erratic behavior reflects broader volatility that harms small biotech firms.
- Kezar Life Sciences kept a conference‑room table and chairs in case a future FDA meeting occurs.
Why it matters: Kezar’s collapse underscores how abrupt FDA actions can wipe out a small biotech’s pipeline, leaving its 60‑person workforce and investors with losses while patients with autoimmune hepatitis lose a potential treatment. The sale to Aurinia offers a slim chance of continuation, but the timeline remains uncertain.
