jumped in premarket trading Tuesday after regulators granted orphan status to the company's lead anticancer drug, forodesine hydrochloride, boosting the Alabama-based biotech's prospects.
The company is currently developing forodesine hydrochloride for the treatment of T-cell mediated cancers. BioCryst also has a phase 2a clinical trial for T-cell leukemia under way.
The two additional indications are for treatment of chronic lymphocytic leukemia and related leukemias as well as acute lymphoblastic leukemia.
The Food and Drug Administration's orphan drug classification is awarded to select approaches that offer potential therapeutic value in the treatment of rare diseases and conditions. Orphan drug status applies to products that treat fewer than 200,000 people and allows seven years of marketing exclusivity for the first company to get approval for such a drug.
"The granting of orphan drug status to forodesine hydrochloride enables BioCryst to receive pre-filing regulatory guidance as well as reduced filing fees," the company said.
The FDA granted the drug orphan status for the treatment of T-cell non-Hodgkin's lymphoma in February 2004.
Shares rose 45 cents, or 7.5%, to $6.49.