Intercept Pharmaceuticals Inc (NASDAQ: ICPT) is having a great start to the trading session this morning, and for good reason. The company announced positive clinical data, exciting investors and pushing the stock on a run for the top. Today, we’ll talk about:
- The clinical data;
- what we’re seeing from ICPT stock as a result; and
- what we’ll be watching for ahead.
ICPT Announces Clinical Data
As mentioned above, Intercept Pharmaceuticals is having a great start to the day today after releasing positive clinical results.
In a press release issued early this morning, the company announced top line results from its pivotal phase 3 REGENERATE study. In the study, ICPT assessed obeticholic acid as an option for patients with liver fibrosis due to nonalcoholic steatohepatitis.
In the release, the company said that the 25 mg dose reached its primary endpoint of firbrosis improvement. The company also said that no worsening of NASH at the planned 18-month interim analysis was demonstrated.
The company said that in the primary efficacy analysis, a greater population of patients in the OCA treatment arms compared to placebo achieved the primary endpoint.
In a statement, Mark Pruzanski, M.D., President and CEO at ICPT, had the following to offer:
We are thrilled to report the first positive registrational Phase 3 study results in patients with NASH, a devastating disease that is on track to become a leading cause of liver transplant in coming years. The topline REGENERATE data we are reporting today support our belief that OCA will become the first approved medicine for those living with liver fibrosis due to NASH. We are deeply grateful to the patients, investigators and study staff whose ongoing participation in REGENERATE has brought us one step closer to delivering a much-needed therapeutic option to address the enormous unmet medical need in this population.
The above statement was followed up by Zobair M. Younossi, M.D., Professor and Chairman at the Department of Medicine at Inova Fairfax Medical Campus, Professor of Medicine at Virginia Commonwealth University, and Chair of the REGENERATE Steering Committee, had the following to offer:
Patients with significant fibrosis due to NASH are at the greatest risk of progression to severe liver-related complications, such as liver failure and death, and fibrosis is considered the strongest predictor of liver-related mortality in this population. I am very encouraged by these results that demonstrate OCA’s ability to significantly improve fibrosis in patients with advanced disease. As the first successful pivotal trial in NASH, REGENERATE is an important advancement for the liver community.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that it’s important to keep a close eye on the news. In particular, the news released by Intercept Pharmaceuticals proved to be overwhelmingly positive. After all, the achievement of the primary endpoint in the Phase 3 trial means that a New Drug Application is likely coming down the line sometime soon, opening the door to a potential revenue stream.
So, it’s not surprising that excited investors are pushing the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:18), ICPT is trading at $134.76 per share after a gain of $23.94 per share or 21.60% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ICPT. In particular, we’re interested in following the story surrounding its OCA treatment product as a submission to the FDA is likely on the horizons. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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