DYAX
There was some discussion of DYAX on the board some months ago.
This morning they released earnings and included the following:
Regulatory Update for DX-88 in HAE
Following recent communications with the FDA with respect to clinical data collected to date through Phase II trials of DX-88 in HAE, Dyax and Genzyme are in ongoing discussions with the agency to plan additional clinical work that will be required to file a Biologics License Application (BLA) for product approval. Based on initial guidance received from the agency, the companies expect to file a BLA after 2005. As dialogue with the FDA continues, Dyax and Genzyme remain committed to treating HAE patients and collecting additional data from their ongoing repeat-dosing trial known as EDEMA2.
Henry E. Blair, Chairman, President and CEO of Dyax Corp., commented "We are currently working with the FDA on a plan for the shortest route to approval for DX-88 in HAE. The agency recognizes the severe and life-threatening nature of HAE, and we received a positive response to our clinical data presented to date. We are confident that we can effectively build on that data to advance DX-88 toward filing a BLA for commercialization."
As recently announced, the FDA granted Fast Track designation to DX-88 for the treatment of HAE. DX-88 also has Orphan Drug designations in both the US and EU for the HAE indication.
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