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Biotech / Medical : Corixa [CRXA] - cancer vaccines -- Ignore unavailable to you. Want to Upgrade?

To: mopgcw who wrote (137)	3/13/2002 10:00:28 PM
From: SemiBull	Respond to of 222

Dealing With Rejection By Lawrence Carrel Corixa Corp. (NASDAQ:CRXA - news) Share price as of Tuesday's close: $9.63 Share price now: $6.15 Change: -36.1% Volume: 9.2 million shares, daily average 493,100 shares Last time this low: Nov. 3, 1998 52-week high: $22.50 52-week low: $6.25 Forward P/E before announcement: n/a Forward P/E after announcement: n/a BACK TO THE drawing board. That's basically what the Food and Drug Administration told Corixa Corp. (NASDAQ:CRXA - news) about Bexxar, its treatment for non-Hodgkin's lymphoma. In a regulatory body slam, the FDA late Tuesday told Corixa that it had failed to provide sufficient evidence of Bexxar's effectiveness and requested additional clinical studies to provide such evidence. Non-Hodgkin's lymphoma, a cancer that attacks the immune system, strikes more than 50,000 Americans a year and is the fifth-leading cause of cancer death. Corixa's stock was body slammed as well, falling 36% Wednesday. The Seattle biotechnology firm, which is developing Bexxar with GlaxoSmithKline (NYSE:GSK - news), has 10 days to respond to the FDA's letter, either by amending or withdrawing its application for fast-track approval or asking for a hearing. Since the FDA was vague on the steps needed for Bexxar's approval, Corixa has also formally requested a meeting with FDA representatives, and expects one within 45 days. This is Bexxar's third roadblock in as many years. By the time Corixa inherited Bexxar through its December 2000 purchase of Coulter Pharmaceutical, the FDA had already declined to review the drug's first application. It was subsequently accepted for review in September 2000. Then, in March 2001, the FDA told Corixa it needed to submit additional clinical and manufacturing information as well as updated or final safety and efficacy data from trials. Corixa resubmitted the data and filed responses to the FDA's request for more information in September. Tuesday's review letter was the response to that filing. The necessary data could take months or years to collect, and Corixa is already under the gun since Zevalin, a rival treatment from competitor Idec Pharmaceuticals (NASDAQ:IDPH - news), received FDA clearance last month. While Corixa has a big pipeline, with 17 other drugs in clinical trial, it doesn't expect to submit any other products for approval until late this year at the earliest. Quote: ``I was not surprised that the company received this kind of communication from the FDA, but I was surprised at how severe the communication seems to be,'' says Brian Rye, analyst at Raymond James & Associates. (Neither he nor his firm hold positions in the stock.) ``The hurdles Bexxar will have to clear have gotten that much tougher. I think it's fair to say another nine to 12 months and maybe longer before they get in front of the FDA again. Our rating has been Market Perform. We are encouraging investors to stay on the sidelines until the face-to-face meeting with FDA. There is currently no positive near-term catalyst to get the stock moving in a positive direction.''