FDA Plays

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astrom Biosciences Inc. (ASTM) received fast-track designation from the Food and Drug Administration for its treatment of a severe form of peripheral artery disease that leads to more than 160,000 limb amputations annually in the U.S. and is potentially fatal.
Shares of the company, which develops cell-therapy technology and devices and specializes in the treatment of cardiovascular diseases, were up 5.4% to $1.55 in recent premarket trading. The stock was down 49% the past year through Friday after falling in January on the company' sale of equity to raise funds for research efforts.
Aastrom President and Chief Executive Tim Mayleben said Monday the FDA's move may accelerate the timing of the company's submissions to the agency and expedite the regulator's review of its marketing application after late-stage trials are completed.