New York, New York--(Newsfile Corp. - January 15, 2026) - Levi & Korsinsky notifies investors that it has commenced an investigation into Vanda Pharmaceuticals Inc. ("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, Learn More About the Investigation or contact Joseph E. Levi, Esq. via email at jlevi@levikorsinsky.com or call (212)363-7500 to speak to our team of experienced shareholder advocates.
WHY LEVI & KORSINSKY: Over the past 20 years, Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States. Attorney Advertising. Prior results do not guarantee similar outcomes.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212)363-7500
Fax: (212)363-7171
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/280525
Source: Levi & Korsinsky, LLP
