Shares of CASI Pharmaceuticals, Inc. (CASI) ended the day up 40%, after the company announced that it had received Orphan Drug Designation from the European Union for its liver cancer drug. The drug from the company which treats hepatocellular carcinoma – liver cancer – is known as ENMD-2076.
In addition to receiving Orphan Drug designation for liver cancer the company also received Orphan Drug designation from the European Union for fibrolamellar carcinoma – rare type of liver cancer. The designation which took place today would give the company’s drug market exclusivity for 10 years.
ENMD-2076 has already received Orphan Drug designation in the U.S. for the liver cancer and fibrolammellar carcinoma – FLC – indication back in 2014. In the U.S. the Orphan Drug designation gave the company 7 years of market exclusivity. CASI states that it will initiate a phase 2 trial and recruit patients in the trial who have FLC in the coming months.
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