Vanda Pharmaceuticals Initiates Thetis Trial for NEREUS to Prevent Vomiting
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy VNDA?
Source: PRnewswire
- Trial Initiation: Vanda Pharmaceuticals has announced the initiation of the Thetis clinical trial to evaluate NEREUS™ (tradipitant) for preventing vomiting in patients receiving GLP-1 receptor agonist therapies, addressing the significant challenge of treatment discontinuation due to nausea and vomiting.
- Drug Background: Recently approved for preventing motion-induced vomiting, NEREUS™ has demonstrated potent antiemetic effects in prior studies, with the potential to improve patient tolerability to GLP-1 therapies, thereby enhancing treatment adherence.
- Trial Design: The Thetis study is a multicenter, randomized, double-blind, placebo-controlled trial primarily assessing the proportion of patients free from vomiting episodes during high-dose GLP-1 treatment, with topline results expected by Q4 2026.
- Previous Study Results: In a prior Phase 2 study, only 29.3% of patients treated with tradipitant experienced vomiting compared to 58.6% in the placebo group, indicating a 50% relative reduction and highlighting NEREUS™'s significant potential to enhance patient experience.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy VNDA?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
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: 7.450
Low
7.50
Averages
13.63
High
22.00
Current: 7.450
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 Initiates Thetis Trial for NEREUS in GLP-1 Therapy
- Trial Initiation: Vanda Pharmaceuticals has announced the initiation of the Thetis clinical trial to evaluate NEREUS™ (tradipitant) for preventing vomiting in patients undergoing GLP-1 receptor agonist therapy, addressing a significant barrier to treatment adherence due to nausea and vomiting.
- Efficacy Validation: In a prior Phase 2 study, only 29.3% of participants treated with tradipitant experienced vomiting compared to 58.6% in the placebo group (p=0.0016), highlighting its potential to mitigate GLP-1 related side effects and improve patient compliance.
- Multicenter Design: The Thetis study is designed as a multicenter, randomized, double-blind, placebo-controlled trial, primarily assessing the proportion of patients free from vomiting episodes during high-dose GLP-1 treatment, which is expected to provide critical data for future drug applications.
- Market Potential: With the increasing use of GLP-1 receptor agonists in diabetes and obesity treatment, the successful development of NEREUS™ could enhance patient quality of life and further strengthen Vanda's competitive position in the biopharmaceutical market.
See More
Vanda Pharmaceuticals Initiates Thetis Trial for NEREUS to Prevent Vomiting
- Trial Initiation: Vanda Pharmaceuticals has announced the initiation of the Thetis clinical trial to evaluate NEREUS™ (tradipitant) for preventing vomiting in patients receiving GLP-1 receptor agonist therapies, addressing the significant challenge of treatment discontinuation due to nausea and vomiting.
- Drug Background: Recently approved for preventing motion-induced vomiting, NEREUS™ has demonstrated potent antiemetic effects in prior studies, with the potential to improve patient tolerability to GLP-1 therapies, thereby enhancing treatment adherence.
- Trial Design: The Thetis study is a multicenter, randomized, double-blind, placebo-controlled trial primarily assessing the proportion of patients free from vomiting episodes during high-dose GLP-1 treatment, with topline results expected by Q4 2026.
- Previous Study Results: In a prior Phase 2 study, only 29.3% of patients treated with tradipitant experienced vomiting compared to 58.6% in the placebo group, indicating a 50% relative reduction and highlighting NEREUS™'s significant potential to enhance patient experience.
See More
EMA's CHMP Reaffirms Decision to Deny Change in Marketing Authorization for Hetlioz (Tasimelteon)
EMA's Recommendation: The European Medicines Agency (EMA) has confirmed its recommendation to reuse a specific change in the marketing authorization process.
Marketing Authorization: This recommendation pertains to the marketing authorization for a product associated with the organization Hetlioz, which is linked to the treatment of certain conditions.
See More
Vanda Pharmaceuticals Raises Concerns Over FDA's New Guidance on Drug Development
- FDA Guidance Concerns: Vanda Pharmaceuticals expressed serious concerns regarding the FDA's draft guidance released on March 18, 2026, which aims to support New Approach Methodologies (NAMs) but fails to deliver the substantial reforms needed for a shift away from animal testing, potentially impacting drug development efficiency and ethical standards.
- Ethics and Science Balance: While Vanda acknowledges the FDA's commitment to improving human predictivity and ethical standards, the draft guidance does not strike a better balance between regulatory caution and the scientific reforms necessary, which could delay patient access to safer drugs and affect Vanda's leadership in innovative drug development.
- Legal Challenges to Animal Testing: Vanda has a proven track record of advocating for science-driven change, including legal challenges against FDA requirements for prolonged animal studies, such as nine-month dog toxicity tests, highlighting the ethical imperative to minimize animal suffering, particularly in dogs.
- Collaboration and Policy Advocacy: Vanda stands ready to partner with the FDA, HHS, and stakeholders to advance regulatory policies that leverage cutting-edge science, protect patient safety, reduce animal suffering, and align with both ethical and scientific imperatives, aiming to accelerate the drug development process.
See More
Vanda Pharmaceuticals Raises Concerns Over FDA's New Draft Guidance
- Draft Guidance Flaws: Vanda Pharmaceuticals expresses serious concerns regarding the FDA's draft guidance released on March 18, 2026, criticizing its lack of concrete non-animal testing alternatives, absence of real-world examples, and performance benchmarks, which could hinder the adoption of innovative tools and impact drug development efficiency and safety.
- Insufficient Scientific Basis: The draft provides limited scientific references and practical examples of validated New Approach Methodologies (NAMs), failing to offer developers clear benchmarks for success, potentially leading to a lack of confidence in new methods and delaying drug market entry.
- Balancing Ethics and Science: CEO Mihael H. Polymeropoulos emphasizes the need for the FDA to strike a better balance between regulatory caution and scientific reform to ensure patients gain faster access to safer drugs while addressing ethical concerns related to animal testing, particularly in dogs.
- Call for Revision: Vanda urges the FDA to withdraw the current draft and substantially revise it with stronger scientific grounding and specific NAM examples to accelerate drug development and reduce animal suffering, ensuring the effectiveness and human relevance of new methods.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several companies, including upgrades, downgrades, and initiations, reflecting varying market perspectives on these firms.
- EQIX Stock Outlook: Analysts' views on EQIX stock indicate a cautious market sentiment regarding its future performance, although specific ratings were not detailed in the report.
- Market Dynamics Overview: Changes in analyst ratings can significantly influence investor decisions, potentially leading to stock price volatility, prompting investors to closely monitor these developments.
- Access More Information: A complete view of all analyst rating changes can be found on Benzinga's analyst ratings page, providing comprehensive market insights and investment references.
See More
Vanda Pharmaceuticals Initiates Thetis Trial for NEREUS in GLP-1 Therapy
- Trial Initiation: Vanda Pharmaceuticals has announced the initiation of the Thetis clinical trial to evaluate NEREUS™ (tradipitant) for preventing vomiting in patients undergoing GLP-1 receptor agonist therapy, addressing a significant barrier to treatment adherence due to nausea and vomiting.
- Efficacy Validation: In a prior Phase 2 study, only 29.3% of participants treated with tradipitant experienced vomiting compared to 58.6% in the placebo group (p=0.0016), highlighting its potential to mitigate GLP-1 related side effects and improve patient compliance.
- Multicenter Design: The Thetis study is designed as a multicenter, randomized, double-blind, placebo-controlled trial, primarily assessing the proportion of patients free from vomiting episodes during high-dose GLP-1 treatment, which is expected to provide critical data for future drug applications.
- Market Potential: With the increasing use of GLP-1 receptor agonists in diabetes and obesity treatment, the successful development of NEREUS™ could enhance patient quality of life and further strengthen Vanda's competitive position in the biopharmaceutical market.
See More
Vanda Pharmaceuticals Initiates Thetis Trial for NEREUS to Prevent Vomiting
- Trial Initiation: Vanda Pharmaceuticals has announced the initiation of the Thetis clinical trial to evaluate NEREUS™ (tradipitant) for preventing vomiting in patients receiving GLP-1 receptor agonist therapies, addressing the significant challenge of treatment discontinuation due to nausea and vomiting.
- Drug Background: Recently approved for preventing motion-induced vomiting, NEREUS™ has demonstrated potent antiemetic effects in prior studies, with the potential to improve patient tolerability to GLP-1 therapies, thereby enhancing treatment adherence.
- Trial Design: The Thetis study is a multicenter, randomized, double-blind, placebo-controlled trial primarily assessing the proportion of patients free from vomiting episodes during high-dose GLP-1 treatment, with topline results expected by Q4 2026.
- Previous Study Results: In a prior Phase 2 study, only 29.3% of patients treated with tradipitant experienced vomiting compared to 58.6% in the placebo group, indicating a 50% relative reduction and highlighting NEREUS™'s significant potential to enhance patient experience.
See More
EMA's CHMP Reaffirms Decision to Deny Change in Marketing Authorization for Hetlioz (Tasimelteon)
EMA's Recommendation: The European Medicines Agency (EMA) has confirmed its recommendation to reuse a specific change in the marketing authorization process.
Marketing Authorization: This recommendation pertains to the marketing authorization for a product associated with the organization Hetlioz, which is linked to the treatment of certain conditions.
See More
Vanda Pharmaceuticals Raises Concerns Over FDA's New Guidance on Drug Development
- FDA Guidance Concerns: Vanda Pharmaceuticals expressed serious concerns regarding the FDA's draft guidance released on March 18, 2026, which aims to support New Approach Methodologies (NAMs) but fails to deliver the substantial reforms needed for a shift away from animal testing, potentially impacting drug development efficiency and ethical standards.
- Ethics and Science Balance: While Vanda acknowledges the FDA's commitment to improving human predictivity and ethical standards, the draft guidance does not strike a better balance between regulatory caution and the scientific reforms necessary, which could delay patient access to safer drugs and affect Vanda's leadership in innovative drug development.
- Legal Challenges to Animal Testing: Vanda has a proven track record of advocating for science-driven change, including legal challenges against FDA requirements for prolonged animal studies, such as nine-month dog toxicity tests, highlighting the ethical imperative to minimize animal suffering, particularly in dogs.
- Collaboration and Policy Advocacy: Vanda stands ready to partner with the FDA, HHS, and stakeholders to advance regulatory policies that leverage cutting-edge science, protect patient safety, reduce animal suffering, and align with both ethical and scientific imperatives, aiming to accelerate the drug development process.
See More
Vanda Pharmaceuticals Raises Concerns Over FDA's New Draft Guidance
- Draft Guidance Flaws: Vanda Pharmaceuticals expresses serious concerns regarding the FDA's draft guidance released on March 18, 2026, criticizing its lack of concrete non-animal testing alternatives, absence of real-world examples, and performance benchmarks, which could hinder the adoption of innovative tools and impact drug development efficiency and safety.
- Insufficient Scientific Basis: The draft provides limited scientific references and practical examples of validated New Approach Methodologies (NAMs), failing to offer developers clear benchmarks for success, potentially leading to a lack of confidence in new methods and delaying drug market entry.
- Balancing Ethics and Science: CEO Mihael H. Polymeropoulos emphasizes the need for the FDA to strike a better balance between regulatory caution and scientific reform to ensure patients gain faster access to safer drugs while addressing ethical concerns related to animal testing, particularly in dogs.
- Call for Revision: Vanda urges the FDA to withdraw the current draft and substantially revise it with stronger scientific grounding and specific NAM examples to accelerate drug development and reduce animal suffering, ensuring the effectiveness and human relevance of new methods.
See More
Wall Street Analysts Adjust Ratings
- Analyst Rating Changes: Top Wall Street analysts have adjusted their ratings on several companies, including upgrades, downgrades, and initiations, reflecting varying market perspectives on these firms.
- EQIX Stock Outlook: Analysts' views on EQIX stock indicate a cautious market sentiment regarding its future performance, although specific ratings were not detailed in the report.
- Market Dynamics Overview: Changes in analyst ratings can significantly influence investor decisions, potentially leading to stock price volatility, prompting investors to closely monitor these developments.
- Access More Information: A complete view of all analyst rating changes can be found on Benzinga's analyst ratings page, providing comprehensive market insights and investment references.
See More
