Can-Fite Biopharma Does It Again With Orphan Drug Designation

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By Chris Lange Published
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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.

ALSO READ: UBS Loves These 3 Top Biotech Stock Leaders Into Q3 Earnings

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.

Photo of Chris Lange
About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.

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