Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy VNDA?
Source: PRnewswire
- New Drug Approval: Vanda Pharmaceuticals announced that its new chemical entity BYSANTI™ (milsaperidone) has received FDA approval as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults, marking a significant advancement in the field of mental health.
- Clinical Advantage: BYSANTI™ demonstrated bioequivalence to iloperidone in clinical studies, leveraging over 100,000 patient-years of real-world experience to ensure its efficacy and safety, which is expected to significantly enhance treatment options for patients.
- Market Outlook: BYSANTI™ is anticipated to be commercially available in Q3 2026, with its marketing exclusivity protected by regulatory data exclusivity and U.S. patents, the latest expiring in 2044, providing a robust foundation for long-term innovation.
- Follow-up Research: BYSANTI™ is currently undergoing a clinical study as an adjunctive treatment for treatment-resistant major depressive disorder, expected to complete by the end of this year, further showcasing Vanda's ongoing innovation in the mental health space.
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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: 6.100
Low
7.50
Averages
13.63
High
22.00
Current: 6.100
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' Bysanti Drug Approved by FDA
- FDA Approval: Vanda Pharmaceuticals' Bysanti drug has received FDA approval for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treating schizophrenia in adults, marking a significant expansion in the company's mental health portfolio.
- Market Launch Timeline: The drug is expected to be available in the market by the third quarter of 2026, providing the company ample time for market preparation, which is crucial for establishing a foothold in the competitive mental health pharmaceuticals sector.
- Recent Drug Approvals: This marks the second drug approval for Vanda in a few months, following the approval of its Nereus drug in December, demonstrating the company's ongoing progress in research and development and bolstering market confidence.
- Stock Price Reaction: Following the FDA approval announcement, Vanda's shares rose 2% in after-hours trading, reflecting investor optimism regarding the new drug's prospects, which may drive future investments and market performance.
See More
Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
- New Drug Approval: Vanda Pharmaceuticals announced that its new chemical entity BYSANTI™ (milsaperidone) has received FDA approval as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults, marking a significant advancement in the field of mental health.
- Clinical Advantage: BYSANTI™ demonstrated bioequivalence to iloperidone in clinical studies, leveraging over 100,000 patient-years of real-world experience to ensure its efficacy and safety, which is expected to significantly enhance treatment options for patients.
- Market Outlook: BYSANTI™ is anticipated to be commercially available in Q3 2026, with its marketing exclusivity protected by regulatory data exclusivity and U.S. patents, the latest expiring in 2044, providing a robust foundation for long-term innovation.
- Follow-up Research: BYSANTI™ is currently undergoing a clinical study as an adjunctive treatment for treatment-resistant major depressive disorder, expected to complete by the end of this year, further showcasing Vanda's ongoing innovation in the mental health space.
See More
Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
- New Drug Approval: Vanda Pharmaceuticals announced that its BYSANTI™ (milsaperidone) has received FDA approval as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults, marking a significant advancement in the field of mental health.
- Clinical Advantages: BYSANTI™ demonstrated bioequivalence to iloperidone in clinical studies, leveraging over 100,000 patient-years of real-world experience to ensure its efficacy and safety, which is expected to enhance treatment options for patients.
- Market Outlook: BYSANTI™ is anticipated to be commercially available in Q3 2026, and with patent protection expiring in 2044, Vanda is positioned to establish a long-term competitive advantage in the mental health market.
- Innovative Development: The unique receptor binding profile of BYSANTI™ makes it suitable for further investigation in other psychiatric conditions, and Vanda plans to explore its use as an adjunctive treatment for treatment-resistant major depressive disorder, showcasing the company's accelerated innovation in drug development.
See More
FDA Sets February 21 Decision Date for Bysanti NDA
- FDA Decision Timeline: The FDA has set February 21, 2025, as the target date for its decision on Vanda Pharmaceuticals' New Drug Application (NDA) for Bysanti, which, if approved, could address the needs of patients with acute bipolar I disorder and schizophrenia in the U.S. market.
- Clinical Research Support: The active ingredient Milsaperidone in Bysanti has shown bioequivalence to the existing drug Iloperidone in clinical studies, with its efficacy and safety backed by data from thousands of patients, thereby enhancing market confidence in the drug's potential approval.
- Market Reaction Analysis: Despite the ongoing FDA review, Vanda's stock fell nearly 3% on Wednesday and another 0.3% in extended trading, indicating investor caution ahead of the FDA decision, with the stock down 32% year-to-date.
- Sentiment Shift: On Stocktwits, retail sentiment for VNDA shifted from 'extremely bullish' to 'bullish', reflecting diverging expectations among investors regarding Bysanti's approval, with some users suggesting that a pullback to $5.30 could present a solid buying opportunity.
See More
Vanda Pharmaceuticals Under Investigation for Securities Fraud
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of Vanda Pharmaceuticals investors regarding potential securities fraud or unlawful business practices by the company and its executives, which could further damage the company's reputation and stock price.
- FDA Application Rejection: On January 8, 2026, Vanda announced that its supplemental New Drug Application for HETLIOZ® was not approved by the FDA; although clinical trials showed positive efficacy, the FDA concluded that the data did not sufficiently demonstrate effectiveness for jet lag disorder, potentially impacting future sales and market outlook.
- Significant Stock Decline: Following the FDA's rejection, Vanda's stock price fell by $1.20, a 14.05% drop, closing at $7.34 per share, which may lead to decreased investor confidence and trigger additional legal actions against the company.
- Litigation Risk: As the investigation unfolds, Vanda may face class action lawsuits, with Pomerantz LLP, a prominent securities litigation firm, potentially seeking damages for investors, which could further affect the company's financial health and market performance.
See More
Vanda Pharmaceuticals Q4 2025 Results Miss Estimates, Shares Drop 15%
- Earnings Miss: Vanda Pharmaceuticals reported Q4 2025 financial results that fell short of expectations, leading to a ~15% drop in stock price during Thursday trading.
- Weak Revenue Guidance: The company projects 2026 revenue between $230 million and $260 million, significantly below the consensus estimate of $271.28 million, indicating uncertainty in future growth prospects.
- Surging Operating Expenses: Total operating expenses surged approximately 54% year-over-year to $97.6 million in Q4, severely impacting profitability and widening GAAP EPS loss to -$2.39.
- Declining Cash Reserves: By the end of 2025, Vanda's cash, cash equivalents, and marketable securities totaled about $263.8 million, a sharp decline from $374.6 million on December 31, 2024, highlighting deteriorating financial health.
See More
Vanda Pharmaceuticals' Bysanti Drug Approved by FDA
- FDA Approval: Vanda Pharmaceuticals' Bysanti drug has received FDA approval for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for treating schizophrenia in adults, marking a significant expansion in the company's mental health portfolio.
- Market Launch Timeline: The drug is expected to be available in the market by the third quarter of 2026, providing the company ample time for market preparation, which is crucial for establishing a foothold in the competitive mental health pharmaceuticals sector.
- Recent Drug Approvals: This marks the second drug approval for Vanda in a few months, following the approval of its Nereus drug in December, demonstrating the company's ongoing progress in research and development and bolstering market confidence.
- Stock Price Reaction: Following the FDA approval announcement, Vanda's shares rose 2% in after-hours trading, reflecting investor optimism regarding the new drug's prospects, which may drive future investments and market performance.
See More
Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
- New Drug Approval: Vanda Pharmaceuticals announced that its new chemical entity BYSANTI™ (milsaperidone) has received FDA approval as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults, marking a significant advancement in the field of mental health.
- Clinical Advantage: BYSANTI™ demonstrated bioequivalence to iloperidone in clinical studies, leveraging over 100,000 patient-years of real-world experience to ensure its efficacy and safety, which is expected to significantly enhance treatment options for patients.
- Market Outlook: BYSANTI™ is anticipated to be commercially available in Q3 2026, with its marketing exclusivity protected by regulatory data exclusivity and U.S. patents, the latest expiring in 2044, providing a robust foundation for long-term innovation.
- Follow-up Research: BYSANTI™ is currently undergoing a clinical study as an adjunctive treatment for treatment-resistant major depressive disorder, expected to complete by the end of this year, further showcasing Vanda's ongoing innovation in the mental health space.
See More
Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
- New Drug Approval: Vanda Pharmaceuticals announced that its BYSANTI™ (milsaperidone) has received FDA approval as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults, marking a significant advancement in the field of mental health.
- Clinical Advantages: BYSANTI™ demonstrated bioequivalence to iloperidone in clinical studies, leveraging over 100,000 patient-years of real-world experience to ensure its efficacy and safety, which is expected to enhance treatment options for patients.
- Market Outlook: BYSANTI™ is anticipated to be commercially available in Q3 2026, and with patent protection expiring in 2044, Vanda is positioned to establish a long-term competitive advantage in the mental health market.
- Innovative Development: The unique receptor binding profile of BYSANTI™ makes it suitable for further investigation in other psychiatric conditions, and Vanda plans to explore its use as an adjunctive treatment for treatment-resistant major depressive disorder, showcasing the company's accelerated innovation in drug development.
See More
FDA Sets February 21 Decision Date for Bysanti NDA
- FDA Decision Timeline: The FDA has set February 21, 2025, as the target date for its decision on Vanda Pharmaceuticals' New Drug Application (NDA) for Bysanti, which, if approved, could address the needs of patients with acute bipolar I disorder and schizophrenia in the U.S. market.
- Clinical Research Support: The active ingredient Milsaperidone in Bysanti has shown bioequivalence to the existing drug Iloperidone in clinical studies, with its efficacy and safety backed by data from thousands of patients, thereby enhancing market confidence in the drug's potential approval.
- Market Reaction Analysis: Despite the ongoing FDA review, Vanda's stock fell nearly 3% on Wednesday and another 0.3% in extended trading, indicating investor caution ahead of the FDA decision, with the stock down 32% year-to-date.
- Sentiment Shift: On Stocktwits, retail sentiment for VNDA shifted from 'extremely bullish' to 'bullish', reflecting diverging expectations among investors regarding Bysanti's approval, with some users suggesting that a pullback to $5.30 could present a solid buying opportunity.
See More
Vanda Pharmaceuticals Under Investigation for Securities Fraud
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of Vanda Pharmaceuticals investors regarding potential securities fraud or unlawful business practices by the company and its executives, which could further damage the company's reputation and stock price.
- FDA Application Rejection: On January 8, 2026, Vanda announced that its supplemental New Drug Application for HETLIOZ® was not approved by the FDA; although clinical trials showed positive efficacy, the FDA concluded that the data did not sufficiently demonstrate effectiveness for jet lag disorder, potentially impacting future sales and market outlook.
- Significant Stock Decline: Following the FDA's rejection, Vanda's stock price fell by $1.20, a 14.05% drop, closing at $7.34 per share, which may lead to decreased investor confidence and trigger additional legal actions against the company.
- Litigation Risk: As the investigation unfolds, Vanda may face class action lawsuits, with Pomerantz LLP, a prominent securities litigation firm, potentially seeking damages for investors, which could further affect the company's financial health and market performance.
See More
Vanda Pharmaceuticals Q4 2025 Results Miss Estimates, Shares Drop 15%
- Earnings Miss: Vanda Pharmaceuticals reported Q4 2025 financial results that fell short of expectations, leading to a ~15% drop in stock price during Thursday trading.
- Weak Revenue Guidance: The company projects 2026 revenue between $230 million and $260 million, significantly below the consensus estimate of $271.28 million, indicating uncertainty in future growth prospects.
- Surging Operating Expenses: Total operating expenses surged approximately 54% year-over-year to $97.6 million in Q4, severely impacting profitability and widening GAAP EPS loss to -$2.39.
- Declining Cash Reserves: By the end of 2025, Vanda's cash, cash equivalents, and marketable securities totaled about $263.8 million, a sharp decline from $374.6 million on December 31, 2024, highlighting deteriorating financial health.
See More
