FDA de­lays Kad­mon’s pri­or­i­ty re­view as ap­par­ent clam­p­down con­tin­ues

Kad­mon Hold­ings just lost their pri­or­i­ty re­view.

The im­munol­o­gy biotech an­nounced Wednes­day that the FDA has pushed back the de­ci­sion date for their graft-ver­sus-host dis­ease drug belu­mo­sudil by three months, af­ter the agency re­quest­ed ad­di­tion­al in­for­ma­tion from the drug­mak­er. That will ef­fec­tive­ly turn their 6-month pri­or­i­ty re­view in­to a 9-month one, just be­low the FDA’s stan­dard de­ci­sion-mak­ing dead­line.

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