Vanda Pharmaceuticals (VNDA) Receives FDA Approval for Nereus Drug
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 31 2025
0mins
Should l Buy VNDA?
Source: Yahoo Finance
- FDA Approval: Vanda Pharmaceuticals announced that its new drug Nereus has received FDA approval, marking a significant advancement in the mental health sector and is expected to generate substantial revenue growth for the company.
- Market Potential: The launch of Nereus is anticipated to meet the increasing patient demand, particularly in treating specific mental health disorders, further solidifying Vanda's market position in the pharmaceutical industry.
- R&D Achievement: This approval represents a major milestone in Vanda's drug development efforts, showcasing its ongoing commitment and capability in innovative drug development, which may attract more investor interest.
- Strategic Implications: The successful launch of Nereus will not only enhance Vanda's brand image but also potentially drive the development and marketing of more drugs in the future, strengthening the company's competitiveness in the highly competitive pharmaceutical market.
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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: 7.510
Low
7.50
Averages
13.63
High
22.00
Current: 7.510
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.
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- Earnings Release Schedule: Vanda Pharmaceuticals will announce its fourth quarter and full year 2025 financial results on February 11, 2026, after market close, highlighting the company's progress in developing innovative therapies.
- Conference Call Details: The company will host a conference call at 4:30 PM ET on the same day, where management will discuss financial results and other corporate activities, likely attracting investor attention and enhancing market transparency.
- Replay Service Availability: A replay of the conference call will be available starting at 8:30 PM ET on February 11, 2026, until February 18, ensuring that investors who cannot participate live can access key information, thereby strengthening investor relations.
- Company Background: Vanda Pharmaceuticals focuses on developing innovative therapies to address high unmet medical needs and improve patient lives, showcasing its leadership position in the biopharmaceutical sector.
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Vanda Pharmaceuticals to Release 2025 Financial Results
- Earnings Release Schedule: Vanda Pharmaceuticals announced it will release its fourth quarter and full year 2025 financial results on February 11, 2026, after market close, reflecting the company's commitment to transparency and investor communication.
- Conference Call Details: The company will host a conference call at 4:30 PM ET on the same day, during which management will discuss financial results and other corporate activities, likely attracting investor interest and boosting market confidence.
- Replay Availability: A replay of the conference call will be available starting at 8:30 PM ET on February 11, 2026, and accessible until February 18, providing convenient access for investors to review the discussions.
- Company Overview: Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on developing innovative therapies to address high unmet medical needs, underscoring its significant position in the industry.
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- Stock Price Plummet: Following the FDA's rejection, Vanda's stock price fell by $1.20, or 14.05%, closing at $7.34 per share, reflecting market concerns about the company's future prospects.
- Legal Implications: The investigation may lead to a class action lawsuit against Vanda, with investors advised to contact Pomerantz LLP, highlighting the company's potential risks and liabilities under securities law.
See More
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- 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.
See More
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- Food Labeling Reform: On January 21, 2026, the U.S. regulator issued a Request for Information aimed at improving gluten ingredient disclosure in foods, particularly focusing on allergic reactions to rye and barley, which could drive significant changes in food industry labeling transparency.
- Future Review Outlook: As February 2026 approaches, several drugs are set for FDA review, with the industry eagerly anticipating the regulatory outcomes, as successful approvals could present substantial market opportunities for related biotech firms.
- Biotech Stock Focus: The FDA's review decisions will directly impact the performance of biotech stocks, prompting investors to closely monitor the upcoming review results to assess market dynamics and investment strategies.
See More
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- FDA Rejection: On January 8, 2026, Vanda Pharmaceuticals announced that the FDA concluded its supplemental New Drug Application (sNDA) for HETLIOZ® cannot be approved in its current form, despite showing positive efficacy in clinical trials, indicating potential legal risks for the company.
- Stock Price Plunge: Following the FDA announcement, Vanda's stock price fell by $1.20, a 14.05% drop, closing at $7.34 per share, reflecting market concerns about the company's future prospects and a loss of investor confidence.
- Investor Alert: Pomerantz LLP is investigating whether Vanda and its executives engaged in securities fraud or other unlawful business practices, advising investors to contact them to join a class action, highlighting the legal pressures that could further impact the company's stock price.
- Historical Context: Pomerantz LLP, a prominent firm in securities class action litigation with over 85 years of experience, focuses on fighting for the rights of victims of securities fraud, indicating that Vanda may face significant legal challenges that could have lasting effects on its operations and reputation.
See More
Vanda Pharmaceuticals to Release 2025 Financial Results
- Earnings Release Schedule: Vanda Pharmaceuticals will announce its fourth quarter and full year 2025 financial results on February 11, 2026, after market close, highlighting the company's progress in developing innovative therapies.
- Conference Call Details: The company will host a conference call at 4:30 PM ET on the same day, where management will discuss financial results and other corporate activities, likely attracting investor attention and enhancing market transparency.
- Replay Service Availability: A replay of the conference call will be available starting at 8:30 PM ET on February 11, 2026, until February 18, ensuring that investors who cannot participate live can access key information, thereby strengthening investor relations.
- Company Background: Vanda Pharmaceuticals focuses on developing innovative therapies to address high unmet medical needs and improve patient lives, showcasing its leadership position in the biopharmaceutical sector.
See More
Vanda Pharmaceuticals to Release 2025 Financial Results
- Earnings Release Schedule: Vanda Pharmaceuticals announced it will release its fourth quarter and full year 2025 financial results on February 11, 2026, after market close, reflecting the company's commitment to transparency and investor communication.
- Conference Call Details: The company will host a conference call at 4:30 PM ET on the same day, during which management will discuss financial results and other corporate activities, likely attracting investor interest and boosting market confidence.
- Replay Availability: A replay of the conference call will be available starting at 8:30 PM ET on February 11, 2026, and accessible until February 18, providing convenient access for investors to review the discussions.
- Company Overview: Vanda Pharmaceuticals is a leading global biopharmaceutical company focused on developing innovative therapies to address high unmet medical needs, underscoring its significant position in the industry.
See More
Vanda Pharmaceuticals Under Investigation for Securities Fraud
- Investigation Launched: Pomerantz LLP is investigating Vanda Pharmaceuticals Inc. for potential securities fraud or unlawful business practices, which could lead to significant losses for investors.
- FDA Application Denied: On January 8, 2026, Vanda announced that its supplemental New Drug Application for HETLIOZ® was not approved by the FDA, despite positive clinical trial results, as the FDA deemed the evidence insufficient for jet lag disorder effectiveness.
- Stock Price Plummet: Following the FDA's rejection, Vanda's stock price fell by $1.20, or 14.05%, closing at $7.34 per share, reflecting market concerns about the company's future prospects.
- Legal Implications: The investigation may lead to a class action lawsuit against Vanda, with investors advised to contact Pomerantz LLP, highlighting the company's potential risks and liabilities under securities law.
See More
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.
See More
FDA Approves Zycubo for Pediatric Menkes Disease Treatment
- FDA Drug Approval: On January 13, 2026, Sentynl Therapeutics' Zycubo received FDA approval as the first treatment for pediatric patients with Menkes disease, representing a significant breakthrough in the treatment of rare neurodegenerative disorders and is expected to enhance patient quality of life.
- Food Labeling Reform: On January 21, 2026, the U.S. regulator issued a Request for Information aimed at improving gluten ingredient disclosure in foods, particularly focusing on allergic reactions to rye and barley, which could drive significant changes in food industry labeling transparency.
- Future Review Outlook: As February 2026 approaches, several drugs are set for FDA review, with the industry eagerly anticipating the regulatory outcomes, as successful approvals could present substantial market opportunities for related biotech firms.
- Biotech Stock Focus: The FDA's review decisions will directly impact the performance of biotech stocks, prompting investors to closely monitor the upcoming review results to assess market dynamics and investment strategies.
See More
Vanda Pharmaceuticals Under Investigation After 14.05% Stock Drop Following FDA Decision
- FDA Rejection: On January 8, 2026, Vanda Pharmaceuticals announced that the FDA concluded its supplemental New Drug Application (sNDA) for HETLIOZ® cannot be approved in its current form, despite showing positive efficacy in clinical trials, indicating potential legal risks for the company.
- Stock Price Plunge: Following the FDA announcement, Vanda's stock price fell by $1.20, a 14.05% drop, closing at $7.34 per share, reflecting market concerns about the company's future prospects and a loss of investor confidence.
- Investor Alert: Pomerantz LLP is investigating whether Vanda and its executives engaged in securities fraud or other unlawful business practices, advising investors to contact them to join a class action, highlighting the legal pressures that could further impact the company's stock price.
- Historical Context: Pomerantz LLP, a prominent firm in securities class action litigation with over 85 years of experience, focuses on fighting for the rights of victims of securities fraud, indicating that Vanda may face significant legal challenges that could have lasting effects on its operations and reputation.
See More
