Billion dollar swings for little biotech yet to sell a drug

Intercept Pharmaceuticals, a New York-based biopharma of fewer than 50 employees, has seen its value gain by four billion US dollars and then fall again by ten-figure amounts.

Shares in the company, which focuses on chronic liver disease and has no products on the market, surged last Thursday, 9th January, from 1.4 billion US dollars to 5.3 billion – the largest leap in a day for any company of such a size since at least 2012, the Wall Street Journal said.

Intercept had announced cessation of one its trials because of positive results for its lead candidate, obeticholic acid, which is at phase 2 and phase 3 stages for a number of potential liver disease indications.

The share value swung back down, however, after the company gave an update on the drug’s safety on Sunday 12th. While the drops were by a third and then another fifth, Bloomberg reported yesterday, the stock is still triple the value it was before the clinical data were first announced.

“The unexpected early stopping of FLINT due to obeticholic acid meeting the primary endpoint with such high significance is a major milestone.

“Non-alcoholic steatohepatitis has grown to epidemic proportions worldwide, having become a leading cause of cirrhosis and liver failure.”

Mark Pruzanski, chief executive, Intercept, in statement 9th January.

“Obeticholic acid is a farnesoid X receptor agonist and we have known for a long time that it is involved in many aspects of lipid metabolism.

“An important part of the rationale for advancing our drug in non-alcoholic steatohepatitis 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.

“It is […] 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.”

Mark Pruzanski in statement 12th January.



Related news:

A $4 billion surprise for 45-person biotech (The Wall Street Journal).

Intercept Pharma, backed by former billionaire, triples after drug test results (Forbes).

Intercept Pharma retreats from big gains (Bloomberg Businessweek).

Reference links:

Intercept announces NASH primary endpoint met: FLINT trial stopped early for efficacy based on highly statistically significant improvement in liver histology (Intercept press release).

Intercept reports additional details about FLINT trial provided by NIDDK (Intercept press release).

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