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Vanda Pharmaceuticals (VNDA) Is Up 13.3% After Rare FDA Hearing Granted on HETLIOZ Jet Lag Bid
Vanda Pharmaceuticals recently received a decision from the U.S. FDA granting a rare formal evidentiary public hearing to review the agency’s proposed refusal to approve a supplemental new drug application for HETLIOZ (tasimelteon) as a treatment for jet lag disorder.
This hearing, which follows Vanda’s earlier legal win requiring the FDA to more fully address its clinical evidence, highlights unusually high regulatory and scientific scrutiny around expanding HETLIOZ into a large, currently...