Levi & Korsinsky notifies investors that it has commenced an investigation into Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) concerning potential violations of the federal securities laws.
Vanda issued a press release on January 8, 2026, "announc[ing] that it has received a decision letter from the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) concluding that the supplemental New Drug Application (sNDA) for HETLIOZ® (tasimelteon) for the treatment of jet lag disorder cannot be approved in its current form." The press release stated that "the FDA acknowledged positive efficacy from Vanda's controlled clinical trials, however, the FDA concluded that these data do not provide substantial evidence of effectiveness for jet lag disorder, primarily on the grounds that controlled phase advance protocols (5-hour and 8-hour bedtime shifts) 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." Following this news, Vanda's stock price fell over 14% on January 8, 2026.
If you suffered a loss on your Vanda Pharmaceuticals Inc. securities and would like to explore a potential recovery under the federal securities laws, submit to us or contact Joseph E. Levi, Esq. via email at [email protected] or call 212-363-7500 to speak to our team of experienced shareholder advocates.
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