(Reuters) - Cell Therapeutics Inc said U.S. health regulators granted orphan drug status to its brain cancer drug, sending the company’s shares up 26 percent in premarket trading.
Orphan status, which is granted by the U.S. Food and Drug Administration to drugs that treat diseases affecting fewer than 200,000 people, provides seven years’ marketing exclusivity from the date of approval.
The designation was granted based on preliminary data from the mid-stage study of the drug, Opaxio, for treating glioblastoma multiforme (GBM), the company said.
GBM is the deadliest and most common type of primary brain tumor in adults.
It is estimated that there will be 10,000-12,000 new cases of GBM diagnosed in the United States this year alone, the company said, citing data from the National Cancer Institute.
Cell Therapeutics’ shares were trading at $2.82. They closed at $2.23 on Monday on the Nasdaq.
Reporting by Balaji Sridharan in Bangalore; Editing by Maju Samuel