A company that is likely to become the first with a drug on the market for a severe form of fatty liver disease has hit an unexpected regulatory speed bump.

New York-based Intercept Pharmaceuticals said Friday that the Food and Drug Administration had pushed its advisory panel meeting, originally scheduled for June 9, to discuss the potential approval of the drug obeticholic acid, or OCA, in nonalcoholic steatohepatitis (NASH). The change was made in order to accommodate the agency’s review of additional data that it had requested. Intercept said it plans to submit the data within the next week.

The FDA has not yet provided the new AdCom meeting date, but the change means the company anticipates that the FDA’s approval decision will extend beyond the original June 26 deadline. This is not the first time the company has hit a delay at the FDA, having announced in December that the AdCom meeting had been scheduled for April 22, meaning that it would miss the initial regulatory deadline of March 26.

Shares of Intercept were down by more than 14% on the Nasdaq shortly after markets opened following the news. The company’s stock closed at $91.69 per share Thursday, falling to less than $80.

“While this delay was unanticipated, following our most recent dialogue with the FDA, we believe that the additional data being submitted will be important in facilitating a more informed discussion at the AdCom,” Intercept CEO Mark Pruzanski said in a statement. “We remain confident in our [new drug application] submission and look forward to continuing to work with the FDA to bring the first treatment to patients with advanced fibrosis due to NASH.”

In a note to investors, Baird analyst Brian Skorney wrote that while he was “incrementally negative” on the update and expected more investor concerns around OCA’s risk-benefit profile in the absence of more information, he and his team still regarded that the drug’s clear benefit on fibrosis will ultimately lead to its approval and strong update in NASH.

The company announced positive data from its Phase III study last February, leading to analysts projecting that it would likely win approval.

OCA has long been considered the leading contender to be the first drug to win approval for NASH, especially after the failure in Phase III development of the drug previously considered to be second in line, Genfit’s elafibranor.

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