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Dyax Completes Rolling BLA For HAE Candidate DX-88

This article was originally published in The Pink Sheet Daily

Executive Summary

Company seeks priority review, which if granted could set an FDA action date in March.

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Dyax’s Acute HAE Candidate Faces Efficacy And Risk Hurdles At Panel Review

Firm is presenting a risk management plan addressing hypersensitivity and anaphylaxis, but efficacy results for Kalbitor (ecallantide) will also be a key discussion topic.

Dyax’s Acute HAE Candidate Faces Efficacy And Risk Hurdles At Panel Review

Firm is presenting a risk management plan addressing hypersensitivity and anaphylaxis, but efficacy results for Kalbitor (ecallantide) will also be a key discussion topic.

Advisory committee to assess DX-88 for HAE

FDA's Pulmonary-Allergy Drugs Advisory Committee will meet Feb. 4 to discuss the BLA for Dyax's hereditary angioedema treatment DX-88 (ecallantide). A positive recommendation from the panel would help DX-88 move forward as potentially the first product approved for the treatment of acute attacks of HAE. Under priority review at FDA, the BLA has an action date in late March (1"The Pink Sheet" DAILY, Sept. 24, 2008)

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