A panel of experts was split Thursday on whether to recommend approval for ChemoCentryx‘s (CCXI) autoimmune disease drug — and CCXI stock plummeted Friday.
ChemoCentryx’s drug, known as avacopan, would treat a rare disorder in which the small blood vessels become inflamed. But members of the advisory committee expressed concern about how ChemoCentryx designed its key study. Some suggested it would need to do additional testing for liver toxicity, SVB Leerink analyst Joseph Schwartz said in a report to clients.
The panel was evenly split on whether the effectiveness results support approval. Meanwhile, 10 said the safety results support approval and eight disagreed.
But do the benefits outweigh the risks? Only 10 voted yes, the remaining eight said no. The Food and Drug Administration doesn’t have to follow the panel’s recommendation, though it often does.
“Given the mostly split vote, we now lack conviction in a positive FDA decision, since it seems likely that the agency will take a harsher stance than the panel,” Schwartz said.
In morning trading on the stock market today, CCXI stock crashed 60% near 11.
CCXI Stock Crashes After Meeting
ChemoCentryx tested avacopan in 331 patients in its final-phase study. Patients received either a combination using avacopan or a standard course of drugs.
But panelists were concerned about the random use of drugs known as glucocorticoids in both groups of patients. Glucocorticoids are part of the usual treatment for the disease, but weren’t officially designated in the study. They are also damaging to use long term.
“The panelists and the agency seemed to agree that the use of non-study supplied glucocorticoids makes it challenging to interpret the (effectiveness) results, muddying the comparison between the two (groups),” Schwartz said.
Panelists were also concerned about liver injuries in avacopan-treated patients, he said.
Schwartz cut his price target on CCXI stock to 17 from 84, but kept his market perform rating.
The news put CCXI stock at its lowest point since November 2019. Shares also crumbled on Tuesday after the FDA released the briefing documents ahead of the advisory committee meeting. Then, CCXI stock plunged more than 43%.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
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