Vanda Pharmaceuticals Initiates Thetis Trial Evaluating Nereus
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 08 2026
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Should l Buy VNDA?
Vanda Pharmaceuticals announced the initiation of Thetis, a clinical trial evaluating Nereus - tradipitant - for the prevention of vomiting in patients receiving glucagon-like peptide-1, or GLP-1, receptor agonist therapies. Nereus was recently approved for the prevention of vomiting induced by motion. GLP-1 receptor agonists have transformed the treatment of type 2 diabetes and obesity. However, gastrointestinal side effects, particularly nausea and vomiting, remain a significant challenge for many patients and are a leading cause of treatment discontinuation or dose reduction. The Thetis study will evaluate the efficacy and safety of oral tradipitant in patients initiated at a high dose of a GLP-1 receptor agonist. The primary endpoint is the proportion of patients free from vomiting episodes during the treatment period. The phase 2 study met its primary endpoint, with only 29.3% of tradipitant-treated participants experiencing vomiting compared to 58.6% on placebo, representing a 50% relative reduction. Vanda expects topline results from the Thetis study by Q4. Following completion of the Thetis study, additional study data may be required prior to approval of a NDA.
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Analyst Views on VNDA
Wall Street analysts forecast VNDA stock price to rise
4 Analyst Rating
3 Buy
1 Hold
0 Sell
Strong Buy
Current: 6.780
Low
7.50
Averages
13.63
High
22.00
Current: 6.780
Low
7.50
Averages
13.63
High
22.00
About VNDA
Vanda Pharmaceuticals Inc. is a global biopharmaceutical company, which is 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 four 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, PONVORY for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease , and NEREUS for the prevention of vomiting induced by motion. In addition, it has a number of drugs and/or additional indications for current products in development, including Bysanti, 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.
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- Vanda's Position: Vanda Pharmaceuticals argues that this change would exacerbate review delays, reduce transparency, and increase risks for small innovators, with CEO Mihael H. Polymeropoulos emphasizing that the FDA should comply with existing laws rather than seek to amend them to allow for slower reviews.
- Legal Context: Vanda highlights that federal courts have ruled the FDA's practice of exceeding the 180-day timeline as unlawful, and the agency currently takes up to two months just to decide whether to file an application, raising concerns about the proposal's implications.
- Industry Impact: The proposal could lead to longer wait times for patients to access new drugs and greater uncertainty for biotech innovators, prompting Vanda to urge FDA Commissioner Dr. Marty Makary to withdraw the provision and call on Congress to reject it.
See More
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- Uncertain Industry Outlook: The future of the healthcare industry faces challenges, particularly in light of changing policies and economic conditions, prompting investors to closely monitor potential impacts from regulatory changes on the sector.
- Long-Term Trends to Watch: Despite the mixed short-term performance of healthcare stocks, the sector is still viewed as having growth potential in the long run, driven by an aging population and increasing health demands.
See More
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- Review Process Changes: The proposal replaces the formal evidentiary hearing process with a weaker internal appeal, potentially reducing transparency and increasing financial risks and uncertainties for small innovative companies like Vanda.
- Legal Compliance Issues: Vanda's CEO Polymeropoulos highlighted that the FDA's current practices have been ruled illegal by federal courts, yet the proposal aims to legalize these delays, indicating a disregard for the law.
- Call to Withdraw Proposal: Vanda urges FDA Commissioner Makary to withdraw the proposal and calls on Congress to reject legislation that could harm patient interests and stifle innovation.
See More
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- Decreased Transparency: The proposal replaces the formal evidentiary hearing process with a weaker internal appeal, potentially diminishing patient transparency and trust in the approval process while entrenching bureaucratic inertia over innovation.
- Legal Compliance Issues: Vanda's CEO Polymeropoulos highlighted that the FDA's current practices have been ruled illegal by federal courts, and this proposal aims to legalize such delays, posing greater financial risks and uncertainties for small innovators.
- Call to Withdraw Proposal: Vanda urges FDA Commissioner Makary to withdraw the proposal and calls on Congress to reject it, emphasizing that it contradicts the goal of improving efficiency and could hinder patient access to necessary drugs.
See More
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- Proposal Overview: Vanda Pharmaceuticals has proposed to eliminate the FDA's 180-day new drug application (NDA) review requirement.
- Impact on Drug Approval: This change could streamline the drug approval process, potentially allowing for faster access to new medications.
See More
