Why Is Vanda Pharmaceuticals Stock Falling In Pre-market?

(RTTNews) - Vanda Pharmaceuticals (VNDA) said it has received a decision letter from the FDA Center for Drug Evaluation and Research concluding that the supplemental New Drug Application for HETLIOZ for the treatment of jet lag disorder cannot be approved in its current form. The FDA concluded that the data do not provide substantial evidence of effectiveness for jet lag disorder, primarily on the grounds that controlled phase advance protocols are not sufficiently analogous to actual jet travel, which according to the FDA involves additional factors such as reduced oxygen pressure, physical constraints, noise, and lighting changes.

Vanda said it remains committed to working constructively with the FDA while pursuing all appropriate avenues to advance approval of HETLIOZ for jet lag disorder.

In pre-market trading on NasdaqGM, Vanda Pharmaceuticals shares are down 13.7 percent to $7.37.

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