Vanda Pharmaceuticals Files BLA for Imsidolimab to Treat GPP
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 hour ago
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Should l Buy VNDA?
Source: PRnewswire
- FDA Acceptance: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application (BLA) for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target action date set for December 12, 2026, marking a significant milestone in addressing rare diseases.
- Clinical Trial Results: In global clinical studies, a single intravenous dose of imsidolimab resulted in 53% of patients achieving clear or almost clear skin at Week 4, compared to only 13% in the placebo group, demonstrating its potential efficacy in treating GPP.
- Addressing Market Needs: If approved, imsidolimab will be Vanda's third new drug approved in the past 12 months, expected to meet a significant unmet medical need in the rare and life-threatening condition of GPP, enhancing the company's competitive position in the biopharmaceutical market.
- Strategic Investment Outlook: Vanda plans to leverage its commercial infrastructure to promote imsidolimab, with regulatory and patent exclusivity anticipated to extend into the late 2030s, further solidifying its market position in the rare disease sector.
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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: 8.170
Low
7.50
Averages
13.63
High
22.00
Current: 8.170
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 Approval of Bysanti Enhances Vanda's Portfolio
- FDA Approval: The FDA's approval of Bysanti as a first-line therapy for bipolar I disorder and schizophrenia is expected to enhance Vanda's portfolio significantly, with commercial availability anticipated in Q3 2026 and marketing exclusivity until 2044.
- Clinical Study Results: Bysanti demonstrated bioequivalence to iloperidone in clinical studies, leveraging efficacy and safety data from Vanda's previous drug, Fanapt, which achieved net sales of $33.2 million in Q4 2025, reflecting a 25% year-over-year increase.
- Market Performance Analysis: Vanda's stock is currently priced at $8.28, trading 5.5% below its 20-day simple moving average, indicating short-term weakness, yet shares have risen 25% over the past 12 months, positioning closer to 52-week highs, suggesting long-term potential.
- Technical Indicators Warning: With an RSI of 50.00 indicating neutral territory and a MACD of 0.10 below its signal line at 0.15, bearish pressure is evident, suggesting that investors should approach the current technical setup with caution.
See More
Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab
- FDA Application Accepted: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application for Imsidolimab, aimed at treating Generalized Pustular Psoriasis (GPP), potentially addressing a significant unmet medical need in this rare and life-threatening condition.
- Positive Market Reaction: Vanda's shares rose nearly 5% in pre-market trading on Wednesday, reflecting investor optimism regarding the FDA approval, which indicates strong confidence in the drug's potential success and market entry.
- Retail Sentiment Surge: Data from Stocktwits shows that retail investor sentiment around Vanda is trending in the 'extremely bullish' territory, suggesting a positive outlook on the company's future performance, which could further drive stock price increases.
- Potential Market Impact: Should the FDA approve Imsidolimab, Vanda would be positioned to enter a market with significant unmet needs, fulfilling urgent demands from GPP patients and enhancing its competitive standing in the biopharmaceutical sector.
See More
Vanda Pharmaceuticals Files BLA for Imsidolimab to Treat GPP
- FDA Acceptance: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application (BLA) for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target action date set for December 12, 2026, marking a significant milestone in addressing rare diseases.
- Clinical Trial Results: In global clinical studies, a single intravenous dose of imsidolimab resulted in 53% of patients achieving clear or almost clear skin at Week 4, compared to only 13% in the placebo group, demonstrating its potential efficacy in treating GPP.
- Addressing Market Needs: If approved, imsidolimab will be Vanda's third new drug approved in the past 12 months, expected to meet a significant unmet medical need in the rare and life-threatening condition of GPP, enhancing the company's competitive position in the biopharmaceutical market.
- Strategic Investment Outlook: Vanda plans to leverage its commercial infrastructure to promote imsidolimab, with regulatory and patent exclusivity anticipated to extend into the late 2030s, further solidifying its market position in the rare disease sector.
See More
Vanda Pharmaceuticals Files BLA for Imsidolimab to Treat GPP
- FDA Filing Acceptance: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application (BLA) for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target decision date of December 12, 2026, marking a significant milestone in the company's efforts in rare diseases.
- Clinical Trial Results: In global clinical studies, a single intravenous dose of imsidolimab resulted in 53% of patients achieving clear or almost clear skin at Week 4, compared to 13% in the placebo group, demonstrating its efficacy and potential competitive edge in the market.
- Safety Profile Advantage: Imsidolimab exhibited a favorable safety profile with a low incidence of anti-drug antibodies, providing a significant advantage over existing treatments and addressing the urgent medical needs of GPP patients.
- Market Potential: If approved, imsidolimab will be the third new drug approved for Vanda in the past 12 months, further solidifying its market position in rare disease treatments and driving future growth for the company.
See More
Vanda Pharmaceuticals' Bysanti Receives FDA Approval
- FDA Approval Milestone: Vanda Pharmaceuticals' Bysanti (milsaperidone) has received FDA approval as a first-line treatment for bipolar I disorder and schizophrenia, marking a significant advancement for the company in the mental health sector.
- Clinical Study Results: Bysanti demonstrated bioequivalence to iloperidone in clinical trials, leveraging over 100,000 patient-years of real-world experience with the company's Fanapt, which is expected to enhance market acceptance and sales potential.
- Commercial Roadmap Outlook: Bysanti is anticipated to be commercially available in Q3 2026, with marketing exclusivity protected by regulatory data exclusivity and US patents expiring in 2044, indicating long-term commercial value.
- Stock Performance Analysis: Vanda Pharmaceuticals' shares surged 35.59% to $7.81 during premarket trading on Monday, despite short-term trading below the 20-day and 100-day simple moving averages, reflecting a positive market reaction to the FDA approval.
See More
Stock Futures Dip as Vanda Pharma Gains on FDA Approval
- Vanda Pharma Approval: Vanda Pharmaceuticals (VNDA) shares surged 33% after the FDA approved Bysanti (milsaperidone) for treating bipolar I disorder and schizophrenia, marking a significant advancement in the mental health sector and expected to drive future sales growth.
- Novo Nordisk Under Pressure: Novo Nordisk (NVO) shares fell 10% as its experimental obesity drug CagriSema failed to meet a key endpoint in a head-to-head study against Eli Lilly's (LLY) tirzepatide, increasing competitive pressure and potentially impacting its future market share.
- VF Corp Downgrade: VF Corp (VFC) shares dropped 4% after JPMorgan downgraded its rating from Neutral to Underweight and cut FY2027 EPS forecast to $0.99, below consensus, indicating significant earnings pressure on the company.
- Market Performance: Stock futures edged lower following President Trump's announcement of a 15% across-the-board tariff, reflecting investor caution regarding economic policy changes and their potential impact on market dynamics.
See More
FDA Approval of Bysanti Enhances Vanda's Portfolio
- FDA Approval: The FDA's approval of Bysanti as a first-line therapy for bipolar I disorder and schizophrenia is expected to enhance Vanda's portfolio significantly, with commercial availability anticipated in Q3 2026 and marketing exclusivity until 2044.
- Clinical Study Results: Bysanti demonstrated bioequivalence to iloperidone in clinical studies, leveraging efficacy and safety data from Vanda's previous drug, Fanapt, which achieved net sales of $33.2 million in Q4 2025, reflecting a 25% year-over-year increase.
- Market Performance Analysis: Vanda's stock is currently priced at $8.28, trading 5.5% below its 20-day simple moving average, indicating short-term weakness, yet shares have risen 25% over the past 12 months, positioning closer to 52-week highs, suggesting long-term potential.
- Technical Indicators Warning: With an RSI of 50.00 indicating neutral territory and a MACD of 0.10 below its signal line at 0.15, bearish pressure is evident, suggesting that investors should approach the current technical setup with caution.
See More
Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab
- FDA Application Accepted: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application for Imsidolimab, aimed at treating Generalized Pustular Psoriasis (GPP), potentially addressing a significant unmet medical need in this rare and life-threatening condition.
- Positive Market Reaction: Vanda's shares rose nearly 5% in pre-market trading on Wednesday, reflecting investor optimism regarding the FDA approval, which indicates strong confidence in the drug's potential success and market entry.
- Retail Sentiment Surge: Data from Stocktwits shows that retail investor sentiment around Vanda is trending in the 'extremely bullish' territory, suggesting a positive outlook on the company's future performance, which could further drive stock price increases.
- Potential Market Impact: Should the FDA approve Imsidolimab, Vanda would be positioned to enter a market with significant unmet needs, fulfilling urgent demands from GPP patients and enhancing its competitive standing in the biopharmaceutical sector.
See More
Vanda Pharmaceuticals Files BLA for Imsidolimab to Treat GPP
- FDA Acceptance: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application (BLA) for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target action date set for December 12, 2026, marking a significant milestone in addressing rare diseases.
- Clinical Trial Results: In global clinical studies, a single intravenous dose of imsidolimab resulted in 53% of patients achieving clear or almost clear skin at Week 4, compared to only 13% in the placebo group, demonstrating its potential efficacy in treating GPP.
- Addressing Market Needs: If approved, imsidolimab will be Vanda's third new drug approved in the past 12 months, expected to meet a significant unmet medical need in the rare and life-threatening condition of GPP, enhancing the company's competitive position in the biopharmaceutical market.
- Strategic Investment Outlook: Vanda plans to leverage its commercial infrastructure to promote imsidolimab, with regulatory and patent exclusivity anticipated to extend into the late 2030s, further solidifying its market position in the rare disease sector.
See More
Vanda Pharmaceuticals Files BLA for Imsidolimab to Treat GPP
- FDA Filing Acceptance: Vanda Pharmaceuticals announced that the FDA has accepted its Biologics License Application (BLA) for imsidolimab to treat Generalized Pustular Psoriasis (GPP), with a target decision date of December 12, 2026, marking a significant milestone in the company's efforts in rare diseases.
- Clinical Trial Results: In global clinical studies, a single intravenous dose of imsidolimab resulted in 53% of patients achieving clear or almost clear skin at Week 4, compared to 13% in the placebo group, demonstrating its efficacy and potential competitive edge in the market.
- Safety Profile Advantage: Imsidolimab exhibited a favorable safety profile with a low incidence of anti-drug antibodies, providing a significant advantage over existing treatments and addressing the urgent medical needs of GPP patients.
- Market Potential: If approved, imsidolimab will be the third new drug approved for Vanda in the past 12 months, further solidifying its market position in rare disease treatments and driving future growth for the company.
See More
Vanda Pharmaceuticals' Bysanti Receives FDA Approval
- FDA Approval Milestone: Vanda Pharmaceuticals' Bysanti (milsaperidone) has received FDA approval as a first-line treatment for bipolar I disorder and schizophrenia, marking a significant advancement for the company in the mental health sector.
- Clinical Study Results: Bysanti demonstrated bioequivalence to iloperidone in clinical trials, leveraging over 100,000 patient-years of real-world experience with the company's Fanapt, which is expected to enhance market acceptance and sales potential.
- Commercial Roadmap Outlook: Bysanti is anticipated to be commercially available in Q3 2026, with marketing exclusivity protected by regulatory data exclusivity and US patents expiring in 2044, indicating long-term commercial value.
- Stock Performance Analysis: Vanda Pharmaceuticals' shares surged 35.59% to $7.81 during premarket trading on Monday, despite short-term trading below the 20-day and 100-day simple moving averages, reflecting a positive market reaction to the FDA approval.
See More
Stock Futures Dip as Vanda Pharma Gains on FDA Approval
- Vanda Pharma Approval: Vanda Pharmaceuticals (VNDA) shares surged 33% after the FDA approved Bysanti (milsaperidone) for treating bipolar I disorder and schizophrenia, marking a significant advancement in the mental health sector and expected to drive future sales growth.
- Novo Nordisk Under Pressure: Novo Nordisk (NVO) shares fell 10% as its experimental obesity drug CagriSema failed to meet a key endpoint in a head-to-head study against Eli Lilly's (LLY) tirzepatide, increasing competitive pressure and potentially impacting its future market share.
- VF Corp Downgrade: VF Corp (VFC) shares dropped 4% after JPMorgan downgraded its rating from Neutral to Underweight and cut FY2027 EPS forecast to $0.99, below consensus, indicating significant earnings pressure on the company.
- Market Performance: Stock futures edged lower following President Trump's announcement of a 15% across-the-board tariff, reflecting investor caution regarding economic policy changes and their potential impact on market dynamics.
See More
