BioCentury
ARTICLE | Regulation

FDA’s avacopan briefing docs suggest ChemoCentryx may have to wait longer for its first approval 

$1.5B in value lost as shares shed 46%

May 5, 2021 1:20 AM UTC

FDA reviewers are concerned that the design of a Phase III study made it hard to draw conclusions about the efficacy of ChemoCentryx’s avacopan vs. its comparators, casting doubt on the molecule’s approvability to treat ANCA-associated vasculitis.

The reviewers’ analysis, published Tuesday in briefing documents ahead of a planned advisory committee meeting Thursday, eroded confidence in the value of ChemoCentryx Inc. (NASDAQ:CCXI), which sank $22.19 (46%) to $26.63, briefly bottoming at $17.79, and shed more than $1.5 billion in market value...

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ChemoCentryx Inc.

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Complement 5a (C5a)