Expert panel split on Thursday whether to recommend approval ChemoCentryxof(CCXI) Autoimmune disease remedies — and CCXI strains plummeted on Friday.
A drug from ChemoCentryx, known as Avakopan, treats a rare disease in which small blood vessels become inflamed. However, advisory board members expressed concern about how ChemoCentryx designed its core study. In a report to the client, SVB Leelink analyst Joseph Schwartz suggested that additional tests for liver toxicity needed to be done.
The panel was evenly divided as to whether the effectiveness results support approval. Meanwhile, 10 said the safety results supported approval, and 8 disagreed.
But do the benefits outweigh the risks? Only 10 people voted in favor, and the remaining 8 voted against. The Food and Drug Administration does not have to follow the panel’s recommendations, but it does.
“Given the majority of the split votes, the FDA is likely to take a tougher position than the panel, so we lack confidence in the FDA’s positive decisions,” Schwartz said.
To Stock market today, CCXI shares plummeted 62% to 10.46.
CCXI stock crash after meeting
ChemoCentryx tested avacopan in 331 patients in a final stage study. Patients received either a combination with Avacopan or a standard medication course.
However, panelists were concerned about the random use of a drug known as glucocorticoid in both patient groups. Glucocorticoids are part of the usual treatment for this disease, but have not been officially designated in this study. They also hurt long-term use.
“Panelists and agents seem to have agreed that the use of glucocorticoids not provided in the study makes it difficult to interpret (effectiveness) results and confuses the comparison between the two (groups),” Schwartz said. He said.
Panelists are also concerned about liver damage in patients treated with Avakopan, he said.
Schwartz lowered the target price for CCXI shares from 84 to 17, but maintained a market performance rating.
The news put CCXI shares at the lowest point since November 2019. Shares also collapsed on Tuesday after the FDA released a briefing document prior to the advisory board meeting. Since then, CCXI shares have plummeted by more than 43%.
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CCXI stock plunge: FDA committee splits on autoimmune drugs
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