- ChemoCentryx is developing Avacopan - a C5 complement receptor inhibitor - for several autoimmune conditions.
- The company has an upcoming PDUFA date for Avacopan in ANCA vasculitis - the FDA will make its decision on whether to approve the drug on October 7th.
- The original date was July 2021 but the decision was delayed after ChemoCentryx provided additional data. An FDA Adcom was split over an approval verdict in May.
- ChemoCentryx stock traded at $68 prior to the Adcom and PDUFA date delay, based on a $1.9bn peak sales potential. Today, shares trade at $20.
- Avacopan won approval in Japan this week - an encouraging sign - but I suspect the FDA may reject the therapy this time around, and that ChemoCentryx market valuation will fall further as a result - it will be a marginal decision.
For further details see:
ChemoCentryx: Make Or Break PDUFA Date For Avacopan May Not Go The Company's Way