FDA Approves Vanda's Bysanti for Bipolar Disorder and Schizophrenia
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
0mins
Should l Buy VNDA?
Source: seekingalpha
- FDA Approval: Vanda Pharmaceuticals' Bysanti (milsaperidone) has received FDA approval for the treatment of bipolar I disorder and schizophrenia, marking a significant advancement for the company in the mental health sector and expected to enhance its market share.
- Stock Surge: Vanda's shares rose approximately 44% in after-hours trading on Friday, reflecting a positive market reaction to the drug's approval, which may attract more investor interest in the company's future growth potential.
- Bioequivalence Established: Studies have shown that milsaperidone is bioequivalent to iloperidone, which was approved in 2009, providing strong support for Bysanti's clinical application and enhancing its competitive position in the treatment market.
- Future Treatment Potential: Bysanti is also in phase 3 trials as an adjunctive treatment for major depressive disorder, and if successful, it will further expand its indications and strengthen the company's strategic position in the psychiatric drug market.
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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.
FDA Approves Vanda's Bysanti for Bipolar Disorder and Schizophrenia
- FDA Approval: Vanda Pharmaceuticals' Bysanti (milsaperidone) has received FDA approval for the treatment of bipolar I disorder and schizophrenia, marking a significant advancement for the company in the mental health sector and expected to enhance its market share.
- Stock Surge: Vanda's shares rose approximately 44% in after-hours trading on Friday, reflecting a positive market reaction to the drug's approval, which may attract more investor interest in the company's future growth potential.
- Bioequivalence Established: Studies have shown that milsaperidone is bioequivalent to iloperidone, which was approved in 2009, providing strong support for Bysanti's clinical application and enhancing its competitive position in the treatment market.
- Future Treatment Potential: Bysanti is also in phase 3 trials as an adjunctive treatment for major depressive disorder, and if successful, it will further expand its indications and strengthen the company's strategic position in the psychiatric drug market.
See More
Vanda Pharmaceuticals' BYSANTI Drug Receives FDA Approval
- FDA Approval: Vanda Pharmaceuticals announced that its new drug BYSANTI has received FDA approval for treating adult Bipolar I manic episodes and schizophrenia symptoms, marking the company's second FDA win in less than two months, showcasing its enhanced R&D capabilities.
- Patent Protection Advantage: Classified as a 'New Chemical Entity', BYSANTI's patent extends to 2044, meaning Vanda will not face generic competition for nearly two decades, providing a long-term revenue moat for the company.
- Stock Surge: Following the FDA approval announcement, Vanda's stock surged 44% in after-hours trading, reflecting investor optimism about the drug's market prospects and strong expectations for potential revenue.
- Broad Market Outlook: BYSANTI is currently being tested as a treatment for major depressive disorder, with results expected by the end of 2026, which could significantly expand its market size and future revenues, further enhancing the company's growth potential.
See More
Vanda Pharmaceuticals' BYSANTI Receives FDA Approval
- FDA Approval: Vanda Pharmaceuticals' BYSANTI has received FDA approval as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults, marking a significant breakthrough in mental health treatment.
- Market Potential: Expected to be commercially available in Q3 this year, BYSANTI, as a new chemical entity, will be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, thus ensuring long-term innovation and patient benefits for the company.
- Recent Drug Approvals: This marks Vanda's second new drug approval in less than two months, following the December 2025 approval of NEREUS for preventing motion-induced vomiting, showcasing the company's ongoing progress in drug development.
- Ongoing Clinical Trials: A phase 3 trial is currently underway to evaluate BYSANTI as a once-daily adjunctive treatment for major depressive disorder, with results expected this year, which could further enhance its competitive position in the market.
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 Approves Vanda's Bysanti for Bipolar Disorder and Schizophrenia
- FDA Approval: Vanda Pharmaceuticals' Bysanti (milsaperidone) has received FDA approval for the treatment of bipolar I disorder and schizophrenia, marking a significant advancement for the company in the mental health sector and expected to enhance its market share.
- Stock Surge: Vanda's shares rose approximately 44% in after-hours trading on Friday, reflecting a positive market reaction to the drug's approval, which may attract more investor interest in the company's future growth potential.
- Bioequivalence Established: Studies have shown that milsaperidone is bioequivalent to iloperidone, which was approved in 2009, providing strong support for Bysanti's clinical application and enhancing its competitive position in the treatment market.
- Future Treatment Potential: Bysanti is also in phase 3 trials as an adjunctive treatment for major depressive disorder, and if successful, it will further expand its indications and strengthen the company's strategic position in the psychiatric drug market.
See More
Vanda Pharmaceuticals' BYSANTI Drug Receives FDA Approval
- FDA Approval: Vanda Pharmaceuticals announced that its new drug BYSANTI has received FDA approval for treating adult Bipolar I manic episodes and schizophrenia symptoms, marking the company's second FDA win in less than two months, showcasing its enhanced R&D capabilities.
- Patent Protection Advantage: Classified as a 'New Chemical Entity', BYSANTI's patent extends to 2044, meaning Vanda will not face generic competition for nearly two decades, providing a long-term revenue moat for the company.
- Stock Surge: Following the FDA approval announcement, Vanda's stock surged 44% in after-hours trading, reflecting investor optimism about the drug's market prospects and strong expectations for potential revenue.
- Broad Market Outlook: BYSANTI is currently being tested as a treatment for major depressive disorder, with results expected by the end of 2026, which could significantly expand its market size and future revenues, further enhancing the company's growth potential.
See More
Vanda Pharmaceuticals' BYSANTI Receives FDA Approval
- FDA Approval: Vanda Pharmaceuticals' BYSANTI has received FDA approval as a first-line therapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for schizophrenia in adults, marking a significant breakthrough in mental health treatment.
- Market Potential: Expected to be commercially available in Q3 this year, BYSANTI, as a new chemical entity, will be protected by regulatory data exclusivity and U.S. patents, with the last patent expiring in 2044, thus ensuring long-term innovation and patient benefits for the company.
- Recent Drug Approvals: This marks Vanda's second new drug approval in less than two months, following the December 2025 approval of NEREUS for preventing motion-induced vomiting, showcasing the company's ongoing progress in drug development.
- Ongoing Clinical Trials: A phase 3 trial is currently underway to evaluate BYSANTI as a once-daily adjunctive treatment for major depressive disorder, with results expected this year, which could further enhance its competitive position in the market.
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
