FDA Seeks More on Dyax's Angioedema Drug
CAMBRIDGE, Mass. -- The Food and Drug Administration wants more information about Dyax's(DYAX Quote) drug candidate DX-88 but won't require the company to conduct more tests, the company said.
Dyax said Thursday the FDA asked for a plan to evaluate and mitigate risks of the drug. The agency also requested more data on the chemistry, manufacturing and controls of DX-88. The product is intended to treat acute attacks of hereditary angioedema, a protein deficiency disease that can cause dangerous swelling under the skin. Last month, an FDA panel recommended that the drug be approved in a vote of six to five, with two panelists abstaining. Shares of Dyax fell 35 cents, or 12.7%, to $2.30 in aftermarket electronic trading Thursday. The stock has ranged from $1.80 to $5.35 over the past year.- Loading Comments...
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