ChemoCentryx: Slumps after FDA staff raises concerns over lead drug

Churchill Capital XI

04/05/2021 18:11

** Drug developer's shares  CCXI.O  fall nearly 60% to an
over 1-yr low of $19.54 - stock set for its biggest one day
percentage fall ever 
    ** U.S. FDA staff reviewing data on the company's drug to
treat vasculitis, a rare genetic disorder that causes blood
vessel walls to thicken, say they have identified concerns
related to the drug's late-stage trial (https://bit.ly/3nKKubX)
    ** FDA staff says the drug was not shown superior to
steroids after 26 weeks, and that it had told the company in the
past that showing the drug is non-inferior to standard-of-care
would not suffice 
    ** The concerns raise uncertainties about how to interpret
the data and the clinical meaningfulness of the results, the
staff said in documents published ahead of a meeting of
independent FDA advisers on Thursday
    ** The committee will vote on whether or not the benefits of
the drug outweigh its risks; the FDA typically follows the
advice of its experts, but is not bound to do so 
    ** Including session losses, shares have fallen ~62% in the
past 12 months

 (Reporting by Manas Mishra in Bengaluru)
 ((Manas.Mishra@thomsonreuters.com;
www.twitter.com/Manasmishra24))