Kezar Life Sciences Stock Soars 40% After FDA Setback Sparks Strategic Shake-Up
Kezar Life Sciences revealed a major regulatory setback for its lead drug and immediately pivoted to consider strategic alternatives. In an October 16 press release, the South San Francisco company announced it failed to reach alignment with the U.S. Food and Drug Administration on the design of a pivotal trial for zetomipzomib in autoimmune hepatitisca.investing.com. The FDA abruptly canceled a Type C meeting that was scheduled for Q4 2025 to discuss Kezar’s proposed Phase 3 trial, and instead requested a new standalone study to characterize zetomipzomib’s pharmacokinetics in patients with severe liver impairmentstocktitan.netstocktitan.net. The agency also mandated 48-hour in-patient monitoring for future trialsca.investing.com – an onerous requirement that Kezar says would likely hinder patient enrollment. This one-two punch from regulators would delay any new AIH trial by roughly two years, the company warnedstocktitan.net. “We are incredibly disappointed with the unusual decision by the FDA to cancel our Type C meeting,” said CEO Chris Kirk, PhD, noting the team had provided extensive safety/efficacy data and a risk mitigation plan for outpatient dosingstocktitan.netstocktitan.net. Kirk added that while Kezar remains excited about zetomipzomib’s potential to be the first approved therapy for AIH, the company “lacks the resources to extend the development timeline” given
