Yes, you're reading this correctly - Intercept Pharmaceuticals Inc. (Nasdaq: ICPT) stock more than tripled today (Thursday).
ICPT shares surged 300% in trading today after an analysis by an independent safety committee showed its liver disease drug met the main goal of a mid-stage trial. ICPT stock closed at $275.49, up 280.56% from Wednesday's closing price of $72.39. The stock climbed as high as $305 in intraday trading.
Boosting shares was speculation the 12-year-old company will be able to receive fast-track regulatory approval for its promising trial drug.
The New York-based development stage biopharmaceutical company, which focuses on the development and commercialization of novel therapies to treat chronic liver diseases, said a trial for its lead product candidate was halted early after the study already met its primary endpoint.
The trial, dubbed FLINT, was being conducted for obeticholic acid (OCA), a potential treatment for the chronic liver disease nonalcoholic steatohepatitis (NASH).
The decision to stop the trial followed the recommendation of the Data and Safety Monitoring Board, which reviewed liver biopsy data in half of the 283 trial patients. The analysis found Intercept's OCA treatment resulted in "highly statistically significant improvement."
Mark Pruzanski, M.D., chief executive officer of Intercept, said in a statement, "The unexpectedly early stopping of FLINT due to OCA meeting the primary endpoint with such high significance is a major milestone. NASH has grown to epidemic proportions worldwide, having become a leading cause of cirrhosis and liver failure. On its current trajectory, the disease is projected to become the leading indication for liver transplant."
If approved, patients receiving OCA could greatly reduce the risk of having to undergo a liver transplant.
A similar trial including 200 patients is currently being conducted in Japan by Intercept's collaborator Dainippon Sumitomo Pharma. Top-line results from the study are expected in 2015.
More Bullish Forecasts for Intercept (Nasdaq: INTC) Stock
Intercept is in the midst of developing OCA for four different liver-related diseases. A phase 3 study in primary biliary cirrhosis is ongoing, with results anticipated later in 2014.
A few analysts weighed in on the latest news:
- BMO analyst Jim Birchenough said, "Results were unexpected, potentially paradigm changing and transformational for ICPT, in our opinion. With an estimated 2.7% of the U.S. population, or 8 million individuals, with advanced liver fibrosis or cirrhosis due to NASH, we would suggest at a minimum that our current peak sales of $865m in primary biliary cirrhosis could be two-fold higher in NASH, with just 2% market penetration. Magnitude of opportunity and timelines for realizing the opportunity are uncertain at this point but could be many fold higher. With potential broader application to patients with obesity, diabetes, and broader non-alcoholic fatty liver disease (NAFLD), we expect significant large pharma interest in ICPT to follow these results."
- Oppenheimer analyst Akiva Felt agreed the Intercept data is "overwhelmingly positive," but reined in near-term expectations. "What's next in NASH? Following the FDA/AASLD [American Association for the Study of Liver Disease] workshop in September, we believe more work needs to be done with the NASH score endpoint before moving into Phase 3. That said, OCA is now the leading candidate in development for this large unmet medical need with no approved therapies."
About 5 million shares of Intercept stock changed hands over four hours Thursday, compared to the average daily volume of 231,500. A conference call is scheduled for 4:30 p.m. ET Thursday.
ICPT isn't the only pharma stock that is expected to reward investors in 2014. In fact, our Private Briefing service has uncovered a number of hot biotech/pharma profits, including this latest: Please Tell Us You're Riding This Biotech Rocket
Intercept Pharma Extends Gains in Premarket; Up 206 Percent
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