Vanda Pharmaceuticals Receives FDA Approval for NEREUS™
Vanda Pharmaceuticals Inc. saw a significant price increase of 33.69%, reaching a 52-week high, amid a broader market decline with the Nasdaq-100 down 0.19% and the S&P 500 down 0.15%.
This surge is attributed to Vanda Pharmaceuticals receiving FDA approval for NEREUS™ (tradipitant), the first new pharmacologic treatment for motion sickness in over 40 years. The approval is expected to significantly enhance patients' quality of life and address the needs of approximately 65 million people in the U.S. suffering from motion sickness, likely driving substantial revenue growth for the company.
The approval of NEREUS™ not only marks a major milestone for Vanda but also positions the company favorably in the biopharmaceutical sector, as it plans to expand the drug's applications to other conditions, further solidifying its market presence.
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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.
- 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.
- 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.
- 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.
- 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.

- 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.








