CASI Pharmaceuticals (CASI) Climbs On Orphan Drug Designation

CASI Pharmaceuticals, Inc. (NASDAQ: CASI)

CASI Pharmaceuticals is having an incredible day in the market today after announcing that it has received Orphan Drug Designation from the European Medicines Agency for it’s primary drug candidate. Today, we’ll talk about the candidate and the Orphan Drug Designation, what we’ve seen in the market today as a result, and what we can expect to see moving forward.

CASI Receives Orphan Drug Designation For ENMD-2076

ENMD-2076 is CASI Pharmaceutical’s primary drug candidate. ENMD-2076 is an oncology candidate that is designed for the treatment of hepatocellular carcinoma. This includes fibrolamellar carcinoma which is a rare type of hepatocellular carcinoma. In a statement, Dr. Ken Ren, CEO of CASI had the following to say:

We are very pleased with the Orphan Drug designation in the EU for HCC. This is an important regulatory milestone for us to enhance the commercial value of ENMD-2076 for global market. We are in the process of initiating our Phase 2 clinical trials in the US for the treatment of FLC and expecting to start patient recruitment very soon. We will seek regulatory approvals and expand the trial into EU once a signal of clinical benefits is indicated in our US trial. As a part of our global development plan, we also have clinical trial application filed with Chinese FDA pending for approval for FLC. We are quite optimistic and committed to the development of ENMD-2076 as a first in line therapy for the treatment of FLC and look forward to advancing its development to the next step.”

How The Market Reacted To The News

As we’ve come to expect anytime we see positive news with regard to a publicly traded biotechnology company, CASI is having an incredible day in the market today. Currently (11:39), the stock is trading at $1.48 per share after a gain of 44.72%.

What We Can Expect To See From CASI Moving Forward

As mentioned above, the news today is incredibly important for CASI. The Orphan Drug Designation gives the company 10 years of market exclusivity in the EU once ENMD-2076 receives marketing authorization in the region. In 2014, CASI also received Orphan Drug Designation for ENMD-2076 in the treatment of HCC by the Food and Drug Administration in the United States. This allows CASI exclusivity in the market in the US for 7 years upon NDA approval. All in all, it seems as though CASI is making the right moves to corner the market and prove their worth in biotechnology. So, I’m expecting to see more overwhelmingly positive news from the stock moving forward.

It is, however, important to remember that market reactions tend to happen through a series of overreactions. That means that we are likely to see declines tomorrow as the stock corrects from the massive gains today.  There’s no reason to be concerned about the declines if they come; this stock is destined for growth in the long run!

What Do You Think?

Where do you think CASI is headed and why? Let us know in the comments below!

[Image Courtesy of Life Sciences Index]

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