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Here's Why Shares Of Intercept Jumped Nearly 10% On Friday

Here's Why Shares Of Intercept Jumped Nearly 10% On Friday

Shares of Intercept Pharmaceuticals Inc (NASDAQ: ICPT) jumped nearly 10 percent early Friday morning after the company provided an update on an ongoing clinical trial.

Intercept is a biopharmaceutical company that focuses on developing and commercializing therapeutics to treat progressive non-viral liver diseases.

Intercept is conducting an ongoing international Phase 3 trial called REGENERATE, which is exploring its OCA (obeticholic acid) in patients suffering from NASH, a progressive liver disease caused by excessive fat accumulation in the liver.

The U.S. Food and Drug Administration has already characterized OCA as a breakthrough therapy and the clinical study was designed in accordance with advance from both the FDA and its European equivalent, the European Medicines Agency.

What Happened On Friday

Intercept announced that it has changed the protocol of its ongoing clinical study based on discussions with the FDA. This is expected to accelerate the completion of the study and improve the chances of a favorable outcome.

As noted by Seeking Alpha, the changes include a new primary endpoint of fibrosis improvement or NASH resolution (previously both) along with a reduction in target enrollment from around 2,000 to now 750.

Of particular note, TheStreet's biotechnology expert Adam Feuerstein tweeted that Intercept hasn't offered proof that the FDA is supportive of the latest developments.

"Are we sick/tired of lack of FDA transparency yet?" the tweet asked.


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