Intercept Pharmaceuticals (ICPT) Sees Pullback from Record Gains

Joel Anderson  |

Intercept Pharmaceuticals (ICPT) continued its wild, roller-coaster ride on Tuesday, with a second-straight day of major losses. Intercept made news last week after its treatment for fatty liver disease, obeticholic acid (OCA), had a Phase II clinical trial halted early because of its efficacy. Shares spiked, then jumped again on the second day after the stock received a raft of massive upgrades from major analysts.

However, this week appears to have seen Intercept return to earth. Shares dropped nearly 20 percent on Monday, and Tuesday saw losses in excess of 30 percent, making the two-day loss nearly 45 percent of its share value. That still has Intercept sporting a five-day gain approaching 450 percent, so investors are hardly sweating recent losses, but it does have the stock returning from the rarified air it reached by the close of markets on Friday.

The plummet for Intercept could be attributed to comments from CEO Mark Pruzanski that his company will most likely need to partner with a larger company to bring OCA to market; a deal that would most likely eat into any potential profits.

“[Intercept’s plan] is very much to build a commercial capability,” the he said in a phone interview with Bloomberg. “But large pharmaceutical companies are very good at this kind of thing. And the overarching responsibility here is to do what we can in a responsible way to get” OCA to patients if it’s approved.

“If that can be done in a more expedited fashion with a partner, that’s something we should consider,” he continued.

However, while these comments from Monday are clearly a factor, profit-taking by traders satisfied with last week’s massive gains and anticipating a market pull-back is probably a contributing factor as well as share-volume continued at very high levels.

The revelation that the study showed rising cholesterol levels for the patients taking OCA as compared to those on a placebo could also be weighing on Intercept’s stock. The details of the study were included in a Sunday press release from Intercept.

"OCA is an FXR agonist and we have known for a long time that it is involved in many aspects of lipid metabolism," said Pruzanski in the release. "An important part of the rationale for advancing our drug in NASH is that by activating FXR in the liver, we believe that it reduces the excess lipid load which is a causal factor in the disease. In addition, there is preclinical evidence that by activating FXR systemically, OCA is able to shunt excess lipids away from collecting in arteries and other organs which could also be beneficial. It is in any case clear that the lipid changes seen in OCA-treated patients are part of a complex set of mechanisms and we are already conducting further studies to gain a more complete understanding of the clinical implications."

The timing of the release and the major decline in shares would seem to indicate that the cholesterol concerns may also be part of the picture this week.

“[While the cholesterol] link is not new news, we believe many investors are seeing it now for the first time,” wrote Oppenheimer & Co. analyst Akiva Felt in a note to clients.

While the Phase II trial showed promising results, some still noted that OCA is still far from approval even if it appears nearly certain to reach that end point.

“What we have is a proof of concept study,” said Nezam Afdhal, head of hepatology at Beth Israel Deaconess Medical Center in Boston. “‘How that becomes a registration trial and an approvable drug is a million-dollar question.’’

The explosion of Intercept’s stock, as well as that of other pharma companies developing similar therapies, indicates that the potential for a successful treatment for fatty liver disease, which is estimated to affect 5 percent of the population, took the markets by surprise to some degree.

And, once again, the markets appeared to treat companies with potential treatments for fatty liver disease as a monolith to some degree, with Intercept's declines appearing to trigger similar declines among its competitors in the fatty liver disease sphere.

Shares in Galectin Therapeutics (GALT) plunged over 12 percent Tuesday to make its two-day losses over 20 percent, while Conatus Pharmaceuticals (CNAT) lost almost 2.75 percent Tuesday for two-day losses just under 20 percent.

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