PHARMAXIS had $175 million wiped off its market value after suffering a setback in getting its cystic fibrosis drug approved for use in the United States.
Advisers to the powerful US Food and Drug Administration (FDA) gave a negative review of Bronchitol, which aims to improve pulmonary function in cystic fibrosis patients aged over six.
The independent expert advisory panel gave the thumbs down on all three areas of a review for the treatment.
"The committee vote is disappointing," Pharmaxis chief executive Alan Robertson said in a statement on Thursday.
"However, we are aware that these recommendations are not binding on the FDA and we will continue the process of working with the FDA to bring Bronchitol to patients in the US."
Shares in Pharmaxis plunged 57 cents, or 45.6 per cent, to close at a 15-month low of 68 cents, with more than 19 million shares having changed hands.
The FDA is expected to make a decision on Bronchitol on March 18.
The drug is already available to patients in Australia and Europe.
Cystic fibrosis affects about 30,000 people in the US and is the most common life-limiting genetic disease.
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