Corixa(CRXA Quote - Cramer on CRXA - Stock Picks) is getting another shot at regulatory approval for its experimental cancer drug, Bexxar.
The Seattle-based biotech firm said Thursday it has won an appeal to the Food and Drug Administration to once again judge the approvability of Bexxar, which is being developed to treat non-Hodgkin's lymphoma.
In March, the FDA issued a "complete review" letter on Bexxar, rejecting its approval based on the need for additional studies to assess the drug's safety and efficacy. Corixa appealed the decision in May, and Thursday the regulatory agency agreed to take another look at Bexxar.
Corixa is developing the drug with GlaxoSmithKline(GSK Quote - Cramer on GSK - Stock Picks).
As a result of the successful appeal, Corixa said it will present additional Bexxar data at a future meeting of the FDA's Oncologic Drug Advisory Committee. The company says it's highly likely that the advisory panel meeting will take place by the end of the year.
Bexxar is a new kind of cancer killer -- a monoclonal antibody with an extra kick of radiation attached that boosts its tumor-killing power.
If approved, Corixa's drug will compete against Zevalin, a similar drug from Idec Pharmaceuticals(IDPH Quote - Cramer on IDPH - Stock Picks) that hit the market earlier this year.
Corixa shares fell 36% to just over $6 on March 13, the day the company received the bad news from the FDA. The stock closed Wednesday at $5.62 per share, but is trading up 88 cents, or 15%, to $6.50 in Thursday premarket activity.



