INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA

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On January 8, 2026, Vanda issued a press release "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." 

On this news, Vanda's stock price fell $1.20 per share, or 14.05%, to close at $7.34 per share on January 8, 2026.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomlaw.com.

Attorney advertising. Prior results do not guarantee similar outcomes.   

CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980

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SOURCE Pomerantz LLP