Can-Fite Biopharma Does It Again With Orphan Drug Designation

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Just recently, Can-Fite Biopharma Ltd. (NYSEMKT: CANF) made a huge splash in the market when it gained a Fast Track designation from the U.S. Food and Drug Administration (FDA) for its treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. Now this biotech has done it again with its most recent announcement coming from Europe.

The company announced that CF102, its oncology drug candidate, has been granted Orphan Drug Designation by the European Medicines Agency (EMA) for the indication of HCC. In the United States, CF102 has already received Fast Track Designation as a second line for the treatment of HCC of patients who have previously received Nexavar (sorafenib) and Orphan Drug Designation for the treatment of HCC.

According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015.

Dr. Pnina Fishman, CEO of Can-Fite, said:

The EMA’s Orphan Drug designation for CF102 is the latest in a series of catalysts that we believe are accelerating the clinical development path of our liver cancer drug towards market approval. As we actively recruit patients in our Phase II study of CF102 in Europe, we are pleased the EMA will support CF102 through protocol assistance and post-authorization market exclusivity.

Can-Fite is an advanced clinical stage drug-development company with a platform technology that is designed to address multi-billion-dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The company has a pipeline of proprietary small molecule drugs that address the aforementioned diseases.

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So far in 2015, Can-Fite has outperformed the market and the stock is up 20% year to date. Over the past 52 weeks, the stock is up 39%.

Shares of Can-Fite were up 12.4% at $4.72 on Monday afternoon. The stock has a consensus analyst price target of $4.00 and a 52-week trading range of $1.46 to $7.85.