Kezar Life Sciences: A Biotech Firm’s Battle for Survival

Kezar Life Sciences finds itself navigating a severe operational crisis, marked by significant regulatory setbacks and a dramatic corporate restructuring. The biopharmaceutical company’s shares are under substantial pressure as its financial reserves diminish and the future of its lead drug candidate, Zetomipzomib, hangs in the balance.

The U.S. Food and Drug Administration (FDA) has delivered a major blow to Kezar’s clinical ambitions. The agency halted the company’s planned registration trial for Zetomipzomib in autoimmune hepatitis, demanding a separate pharmacokinetic study in patients with liver impairment first. This requirement is projected to delay the program by approximately two years.

Compounding the challenge, the FDA is also Read more...