Dyax Corp. said the Food and Drug Administration accepted the Cambridge company's response to a request for more information on the drug candidate DX-88.
In March, the agency asked for more information, specifically on a plan to evaluate and mitigate risks of the drug. The agency also requested more data on chemistry, manufacturing and controls. DX-88 is intended to treat acute attacks of hereditary angioedema, a protein deficiency disease that can cause dangerous swelling under the skin.
In February, an FDA panel recommended that the drug be approved in a vote of six to five, with two panelists abstaining.
Dyax said the FDA is expected to make a decision on the drug candidate by Dec. 1.
Shares of Dyax rose 23 cents, or 12 percent, to $2.10 in morning trading. (AP)