Vanda Submits BLA for Imsidolimab to Treat GPP
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
0mins
Should l Buy VNDA?
Source: PRnewswire
- Critical Application Submission: Vanda Pharmaceuticals has submitted a Biologics License Application (BLA) for imsidolimab aimed at treating the rare condition generalized pustular psoriasis (GPP), marking a significant step in addressing a major unmet medical need.
- Clinical Trial Results: In the global Phase 3 GEMINI-1 and GEMINI-2 studies, 53% of patients receiving a single intravenous dose of 750 mg imsidolimab achieved clear or almost clear skin, significantly outperforming the 13% in the placebo group, indicating the drug's potential in treating GPP.
- Favorable Safety Profile: Imsidolimab demonstrated a favorable safety profile with no treatment-related serious adverse events reported during clinical trials, enhancing its market appeal as a new therapeutic option.
- Priority Review Request: Vanda has requested priority review from the FDA for the BLA, and if granted, could lead to potential approval by mid-2026, accelerating the drug's market entry to meet urgent patient needs.
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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: 6.120
Low
7.50
Averages
13.63
High
22.00
Current: 6.120
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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- 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.
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Vanda Pharmaceuticals Q4 2025 Results Miss Estimates, Shares Drop 15%
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- Future Outlook: Vanda projects total revenue between $230 million and $260 million for 2026, with Fanapt sales expected to range from $150 million to $170 million, while other products are anticipated to contribute between $80 million and $90 million, demonstrating the company's confidence in its product pipeline and market potential.
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- Revenue Growth Lags: Despite a 7.6% year-over-year revenue increase to $57.22 million, the figure fell short of expectations by $2.05 million, reflecting unmet market demand that may necessitate adjustments in future sales strategies.
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See More
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- 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.
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See More
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- 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
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- 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 Plans to Raise $200 Million Through Securities Offerings
- Funding Strategy: Vanda Pharmaceuticals plans to raise up to $200 million through future securities offerings, providing the company with flexibility to access capital markets when conditions permit, which is crucial for its growth strategy.
- Q4 Financial Performance: In the fourth quarter, Vanda reported total net product revenue of $57.2 million, an 8% year-on-year increase, but the loss per share (EPS) of $2.39 fell short of analysts' expectations of $59.28 million and a loss of $1.32, indicating challenges in meeting market forecasts.
- Tax Provision Impact: The company recorded a $103.2 million tax provision, largely due to a $113.7 million valuation allowance against deferred tax assets, a non-cash charge that negatively impacted its financial results and reflects ongoing tax strategy adjustments.
- Future Outlook: Vanda projects total revenue between $230 million and $260 million for 2026, with Fanapt sales expected to range from $150 million to $170 million, while other products are anticipated to contribute between $80 million and $90 million, demonstrating the company's confidence in its product pipeline and market potential.
See More
Vanda Pharmaceuticals Releases 2026 Financial Objectives Amid Q4 Earnings Miss
- Earnings Miss: Vanda Pharmaceuticals reported a Q4 GAAP EPS of -$2.39, missing estimates by $1.07, indicating ongoing profitability challenges that could undermine investor confidence.
- Revenue Growth Lags: Despite a 7.6% year-over-year revenue increase to $57.22 million, the figure fell short of expectations by $2.05 million, reflecting unmet market demand that may necessitate adjustments in future sales strategies.
- 2026 Financial Guidance: The company projects total revenues between $230 million and $260 million for 2026, with Fanapt® net product sales expected to range from $150 million to $170 million, and other net product sales between $80 million and $90 million, indicating cautious optimism for future growth.
- Negative Stock Reaction: Following the earnings release, Vanda's shares fell by 10.77% in after-hours trading, signaling market disappointment with the results, which could impact the company's future financing capabilities and market positioning.
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
