ChemoCentryx Stock Plunges As FDA Briefing Document Casts Doubt On Vasculitis Candidate Avacopan's Data


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  • ChemoCentryx Inc (NASDAQ: CCXI) shares plunged after an FDA briefing document indicates the agency has “several areas of concerns” with its vasculitis candidate, avacopan.
  • The FDA document raised questions regarding the “interpretability of the data and the clinical meaningfulness of these results” as summarized below:
    • At Week 26, the proportion of patients in disease remission in the avacopan group (72.3%) was non-inferior to the prednisone group (70.1%) according to the Applicant’s testing plan.
    • Interpretation of the non-inferiority at Week 26 is limited by a large number of patients in the avacopan arm (86%) who received non-study-supplied glucocorticoids from Week 0 to 26.
    • While the mean cumulative glucocorticoid dose per patient over Week 0 to 26 was lower (1072.9 mg) in the avacopan-treated patients, compared to the mean cumulative dose in the prednisone-treated patients (3192.5 mg), the non-inferiority assessment is not a comparison of avacopan vs. prednisone, but instead avacopan plus lower dose glucocorticoids vs. higher dose glucocorticoids.
    • The document also takes issue with the complex trial design and the lack of long-term safety data.
  • Price Action: CCXI shares dropped 52.3% at $23.27 during the market trading session on the last check Tuesday.

27% profits every 20 days?

This is what Nic Chahine averages with his options buys. Not selling covered calls or spreads... BUYING options. Most traders don't even have a winning percentage of 27% buying options. He has an 83% win rate. Here's how he does it.


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Posted In: BiotechNewsHealth CareSmall CapFDAGeneralBriefsVasculitis