Shares of ChemoCentryx dropped nearly 45% on Tuesday after the FDA questioned the rationale behind some of the clinical data for its experimental autoimmune disease treatment avacopan, reported MarketWatch.
ChemoCentryx is seeking approval for avacopan to treat anti-neutrophil cytoplasmic auto-antibody-associated vasculitis, and the FDA questions were in briefing documents released in advance of an advisory committee meeting scheduled for Thursday.
SVB Leerink analyst Joseph Schwartz said the briefing documents are "surprisingly critical and suggest that CCXI has an uphill battle."
Meanwhile, Raymond James analyst Steven Seedhouse also described his surprise at the FDA's decision to question the investigational therapy's safety and efficacy, although he still expects a positive decision from the committee.
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