FDA delay cited in closure of biotech studying autoimmune hepatitis
statnews.com • • business
Key Points:
- Kezar Life Sciences faced a critical setback when the FDA abruptly canceled a key meeting in October to discuss the design of a clinical trial for its autoimmune hepatitis treatment, delaying progress by four months.
- The delay caused investor withdrawal and forced Kezar to lay off most of its 60 employees, sell lab equipment, and begin winding down operations.
- After eventually reaching an agreement with the FDA in February, Kezar announced it would be sold to Aurinia Pharmaceuticals, which may continue development of the drug, though the timeline remains uncertain.
- CEO Chris Kirk criticized the FDA's recent volatility and inconsistent decision-making, noting that such unpredictability disproportionately harms small biotech firms reliant on continuous financing.
- Kirk emphasized that the current FDA environment undermines trust and poses risks to patients and the broader biotech industry.
.png?format=webp&w=120&h=80)
