Anti-GBM Program Failure And Valuation ImpactUnexpected placebo responses in a Phase 3 anti-GBM study led analysts to remove the program from models, reflecting notable pipeline uncertainty and downward valuation pressure.
Partner Trial Termination And Lost MilestonesTermination of a partnered gene therapy trial eliminated expected milestone payments, weakening near-term revenue visibility and prompting analyst price target reductions.
Regulatory Evidentiary RiskNew leadership at the regulator has raised the evidentiary bar for accelerated approvals, increasing the risk that submissions relying on surrogate endpoints face tougher scrutiny.