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Nuvelo colon cancer drug candidate granted fast-track status by FDA; shares surge premarket

Biotech drug maker Nuvelo Inc. said Tuesday the Food and Drug Administration has granted "fast-track" status to its colon cancer drug candidate as both a first- and second-line treatment.

Biotech drug maker Nuvelo Inc. said Tuesday the Food and Drug Administration has granted "fast-track" status to its colon cancer drug candidate as both a first- and second-line treatment.

The fast-track status for Nuvelo's rNAPc2 covers usage of the drug as an initial treatment of first-time colon cancer and as a second-line treatment when combined with Genentech Inc.'s Avastin-based chemotherapy.

The company's rNAPc2 is currently being studied in a mid-stage clinical trial.

Fast-track status means Nuvelo can submit data to the FDA as it becomes available, rather than having to wait to submit it all at once for approval.

Shares surged 91 cents, or nearly 30 percent, to $4 in premarket electronic trading, having closed Monday at $3.09 on the Nasdaq Stock Market.