Can-Fite BioPharma Ltd. (NYSEMKT: CANF) is building momentum with its most recent designation from the U.S. Food and Drug Administration (FDA). The company announced the FDA has granted the drug candidate CF102 Fast Track designation as a second line treatment for hepatocellular carcinoma (HCC), the most common form of liver cancer. CF102 had already received the FDA’s Orphan Drug designation.
A Phase 2 study is already underway for this indication in the United States, Europe and Israel. According to Global Industry Analysts, the global market for liver cancer drugs is projected to exceed $2 billion in 2015.
Can-Fite is an advanced clinical stage drug-development company with a platform technology that is designed to address multibillion 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.
Dr. Pnina Fishman, CEO of Can-Fite, said:
We are very pleased that the FDA recognizes the potential for CF102 to treat HCC patients who have tried, and not been responsive to Nexavar, the only FDA approved drug currently on the market for this indication. We consider Fast Track designation to be a major catalyst for our CF102 development program and we believe it could shorten our time to market for CF102, thereby making a considerable difference for patients.
In 2015, the company has far underperformed the market, with the stock down 52% year to date. That is nearly the same loss over the past 52 weeks.
Shares of Can-Fite were up 35% at $2.27 on Thursday morning. The stock has a consensus analyst price target of $3.65 and a 52-week trading range of $1.46 to $5.83.