Intercept Pharmaceuticals (ICPT) Stock: FDA Approves Ocaliva

Intercept Pharmaceuticals Inc (NASDAQ: ICPT)

Intercept Pharmaceuticals investors have something big to be excited about. The company announced, late on Friday, that the FDA has granted the company approval on one of their liver treatments. Today, we’ll talk about the approval, what we’re seeing in the market as a result, and what we can expect to see from ICPT moving forward. So, let’s get right to it!

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ICPT Announces FDA Approval Of Ocaliva

Intercept Pharmaceuticals has been working on Ocaliva for some time now. The treatment is designed to be used in combination with ursodeoxycholic (UDCA) in order to improve conditions for adults that are currently suffering from primary biliary cholangitis. Ocaliva is an agonist of the farnesoid X receptor, which is a nuclear receptor expressed in the liver and intestine. Ocaliva was approved by the FDA under accelerated approval. The approval was based on a reduction in alkaline phosphate. In a statement, Mark Pruzanski, M.D., President and CEO at ICPT, had the following to offer about the news:

Intercept was founded on the belief that targeting FXR would benefit patients with liver diseases for which there are limited or no treatment options, and Ocaliva’s approval marks the culmination of more than a decade of work… We are very pleased that the FDA has approved Ocaliva for PBC and would like to thank all the patients and investigators around the world who participated in our clinical trials to make this possible.”

This statement was followed up by John Vierling, M.D., F.A.C.P., F.A.A.S.L.D., Professor of Medicine and Surgery at Baylor College of Medicine and Past President of the American Association for the Study of Liver Diseases. Here’s what he had to say:

Ocaliva files an important unmet need for the many patients with PBC who have an inadequate response to or are intolerant of UDCA, which until now has been the only approved treatment… Ocaliva has demonstrated a clinically meaningful improvement in lowering ALP, a liver enzyme and biomarker that is used to track disease progression in patients with PBC. Importantly, Ocaliva maintained durable ALP reductions, which is critical for the treatment of a chronic disease like PBC.”

How The Market Reacted To The News

As investors, one of the first things that we learn is that the news moves the market. In most cases, when positive news is released, we can expect to see gains in the value of the stock associated with the news. Adversely, negative news will generally lead to declines. While the news released with regard to ICPT was overwhelmingly positive, investors seem to be uncertain about the stock at the moment. Surprisingly enough, we are currently seeing declines. Currently (9:55), Intercept Pharmaceuticals stock is trading at $140.90 per share after a loss of $0.87 per share, or 0.61%, thus far today.

What We Can Expect To See Moving Forward

Moving forward, I have an overwhelmingly bullish opinion of what we can expect to see from ICPT. The reality is that, through Ocaliva, the company has come up with a treatment that is very needed in the medical industry at the moment. The treatment will likely lead to strong profits in the future. However, Ocaliva isn’t the only thing that ICPT has going for it. At the end of the day, the company has a tremendous pipeline as well as an amazing team. This is, generally, a combination that ends in incredible growth!

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What Do You Think?

Where do you think ICPT is headed moving forward and why? Let us know your opinion in the comments below!

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