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ChemoCentryx Nosedives on Split FDA Panel Decision

ChemoCentryx falls on the FDA committee's lukewarm support and analysts' downgrades.

ChemoCentryx  (CCXI) - Get ChemoCentryx Inc. Report plummeted by record levels Friday after a regulatory panel gave mixed support to the biotech's experimental autoimmune drug, prompting analysts to slash their ratings and price targets.

Shares of the Mountain View, Calif. company ended down nearly 62% to $10.46.

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The company said that the U.S. Food & Drug Administration's Arthritis Advisory Committee had voted 10-8 that the safety profile of ChemoCentryx's avacopan is adequate to support approval of the candidate for the treatment of adult patients with AAV, a rare autoimmune disease.

The committee was split 9-9 on whether the efficacy data supported approval of avacopa for the treatment of adult patients with AAV.

"We are grateful to the Committee for their careful deliberations and look forward to working with the FDA as its review of our application continues,” Thomas Schall, president and CEO, said in a statement.

Shares had dived earlier this week after the FDA posted a document that questioned the rationale behind some of the clinical data for avacopan.

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Analysts were quick to respond to the committee's rulings.

Stifel analyst Dae Gon Ha downgraded ChemoCentryx to hold from Buy with a price target of $26, down from $93, according to the Fly.

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With split voting results between FDA panel members, the analyst sees a "greater risk" heading into FDA's decision scheduled for July 7. 

"We were wrong, and we are now moving to the sidelines," Gon Ha said in a research note.

H.C. Wainwright analyst Edward White lowered the firm's price target on ChemoCentryx to $28 from $101 and keeps a Buy rating on the shares. 

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White said he believed the mixed FDA panel opinion is negative for potential of approval and a "significant negative" for the stock.

Raymond James analyst Steven Seedhouse downgraded the stock to outperform from strong buy and cut his price target to $51.00 from $120. 

Seedhouse noted that "if approved we still think avacopan is a blockbuster drug."

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"Yes, we’re calling this a pure coin flip between now and July 7," he said.

The analyst said he thought the panelists were "unreasonable and unprepared (e.g., wanted larger safety database, more trials, unrealistic trial designs for this serious and rare disease)."