Medarex Gains on FDA Move

The company is granted fast-track approval status for its melanoma vaccine.
Publish date:

Shares in



jumped early Tuesday after the New Jersey biotech company said regulators had granted fast-track approval for its melanoma vaccine.

Medarex is currently conducting phase III clinical tests of the treatment, known as MDX-010 and MDX-1379 combination therapy, for two stages of metastatic melanoma.

Under fast-track status, the Food and Drug Administration seeks to expedite the approval process for treatments of serious and/or life-threatening diseases.

Melanoma accounts for about 4% of skin cancer cases, but causes about 80% of skin cancer deaths. In the U.S., nearly 8,000 people are expected to die of melanoma in 2004, according to the company.

Medarex shares rose 44 cents, or 5.6%, to $8.32 in premarket trading.