Vanda Pharmaceuticals' HETLIOZ® Faces Delay as FDA Rejects Current Efficacy Evidence
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 08 2026
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Source: Newsfilter
- FDA Rejection: Vanda Pharmaceuticals' supplemental New Drug Application (sNDA) for HETLIOZ® targeting jet lag disorder was rejected by the FDA, primarily due to insufficient evidence of efficacy, which negatively impacts the company's future market prospects.
- Clinical Trial Results: Although the FDA acknowledged positive efficacy from Vanda's clinical trials, it concluded that the current trial designs do not adequately simulate actual flight conditions, potentially diminishing HETLIOZ®'s market acceptance.
- Legal Progress: In August 2025, the D.C. Circuit overturned a prior FDA rejection, describing Vanda's evidence as
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Analyst Views on VNDA
Wall Street analysts forecast VNDA stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for VNDA is 13.63 USD with a low forecast of 7.50 USD and a high forecast of 22.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 7.690
Low
7.50
Averages
13.63
High
22.00
Current: 7.690
Low
7.50
Averages
13.63
High
22.00
About VNDA
Vanda Pharmaceuticals Inc. is a global biopharmaceutical company focused on the development and commercialization of therapies to address unmet medical needs and improve the lives of patients. The Company’s commercial portfolio consist of three products: Fanapt for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) and for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome (SMS) and PONVORY for the treatment of relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease. In addition, it has a number of drugs and/or additional indications for current products in development, including Bysanti, Tradipitant, Imsidolimab, VTR-297, VQW-765, and others. Bysanti is the active metabolite of Fanapt.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Vanda Pharmaceuticals Under Investigation for Securities Fraud Claims
- Securities Fraud Investigation: Pomerantz LLP is investigating whether Vanda Pharmaceuticals Inc. has engaged in securities fraud or other unlawful business practices, advising investors to contact their attorneys for further information.
- FDA Application Rejection: On January 8, 2026, Vanda announced that its supplemental New Drug Application for HETLIOZ® was not approved by the FDA, which acknowledged positive clinical trial results but deemed the evidence insufficient for treating jet lag disorder.
- Significant Stock Drop: Following the FDA's rejection, Vanda's stock price fell by $1.20, or 14.05%, closing at $7.34 per share, indicating market concerns regarding the company's future prospects.
- Potential Legal Consequences: The investigation could lead to class action lawsuits against Vanda, and if misconduct is proven, it may have significant repercussions on the company's reputation and financial health.
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