FDA Rejects Intercept’s Liver Disease Drug, But This Analyst Still Anticipates Approval

FDA Rejects Intercept’s Liver Disease Drug, But This Analyst Still Anticipates Approval

No pain, no gain goes the well-worn axiom. A stock market themed inverse can read: no gain, shareholder pain. You can currently apply the latter to Intercept Pharmaceuticals (ICPT). The small-cap biotech was hoping to gain the FDA’s nod of approval for its liver disease therapy, but there was only pain to endure, as the NDA was rejected. As a result, shares were sent tumbling by 40% on Monday June 29. 

So, what happened exactly? ICPT received a CRL from the FDA regarding its obeticholic acid (OCA) treatment in advanced-stage non-alcoholic steatohepatitis (NASH), due to a lack of evidence showing that the benefits of the treatment outweigh the potential risks. The FDA recommended that data from the ongoing Phase 3 REGENERATE study be further analyzed. 

NASH is a fatty liver disease, closely related to obesity, for which there are currently no specific drugs available. Due to the rising obesity rates, the market for NASH medications is expected to grow considerably over the next few years, with some estimates putting its worth at $35 billion. 

Intercept’s application was based on data from the treatment of over 1,700 NASH patients across 35 clinical trials. Management expects to schedule a meeting with the FDA in 2H20 to discuss how to move forward.  

Needham analyst Alan Carr expects the NDA to be resubmitted before the end of the year, and anticipates “the drug will be approved in the U.S. by mid-2021.” The analyst believes the rejection might have more to do with the current macro climate than with the data itself. 

Carr said, “We acknowledge the FDA clearly has some level of concern w/ OCA, however, we believe COVID-19 has played a role in disrupting and preventing completion of the review process. We await the outcome of the meeting with the FDA and assume resubmission by YE20. We still believe OCA will be approved in NASH, but have reduced our target due to launch delay.” 

That price target is slashed from $150 to $100, although the figure still implies hefty upside potential of 115%. Carr made no change to the rating, which remains a Buy. (To watch Carr’s track record, click here

Looking at the consensus breakdown, based on 6 Buys and 15 Holds, ICPT has a Moderate Buy consensus rating. With an average price target of $66.10, the analysts forecast possible upside of 42% over the next 12 months. (See Intercept price targets and analyst ratings on TipRanks

The post FDA Rejects Intercept’s Liver Disease Drug, But This Analyst Still Anticipates Approval appeared first on TipRanks Financial Blog.

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