HEALTH : Gensia Shares Fall 32% on Rejection
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SAN DIEGO — Gensia Inc. shares fell 32% on Monday after the company said U.S. regulators rejected its application for a product to detect coronary-artery disease.
The biotechnology company said the Food and Drug Administration told it its application for Genesa cannot be approved based on the information provided.
The company’s shares fell $1.125 to close at $2.375.
Gensia said it will meet with the FDA as soon as possible to discuss its next step.
Failure to obtain U.S. marketing approval for Genesa will have an adverse effect on its annual earnings, Gensia said.
Genesa is a drug and a computer-controlled drug-administering system for use in diagnosing coronary-artery disease in people who cannot exercise regularly.
Gensia was awarded a U.S. patent for the material used in Genesa, and the company has received product approval in Britain, Germany, Ireland and Sweden.
Disappointments with new products have depressed Gensia’s shares since Jan. 31, 1994, when they reached a high of $25.375. During the past year, two products being developed by Gensia have failed crucial tests.
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