Vanda surges as FDA approves Bysanti for bipolar disorder, schizophrenia
Vanda Pharmaceuticals saw a significant stock increase after the FDA approved its drug Bysanti for the treatment of bipolar I disorder and schizophrenia. This approval is expected to expand the market potential for the drug, which had previously been approved for schizophrenia alone. The company is already preparing for the commercial launch of Bysanti.
FDA Approval Boosts Vanda Pharmaceuticals (VNDA) Shares by 44%
Vanda Pharmaceuticals (VNDA) saw its shares jump by 44% following FDA approval for its drug Bysanti, intended for treating bipolar I disorder and schizophrenia. Despite this market boost, the company faces significant financial challenges, including negative earnings, declining revenue growth, and poor scores on financial health indicators like the Altman Z-Score and Piotroski F-Score. Investors are advised to consider these risks despite Bysanti's potential to improve Vanda's market position.
Vanda Pharmaceuticals stock surges after the FDA approves its new Bipolar I drug
Vanda Pharmaceuticals' stock surged 44% after the FDA approved its new drug, BYSANTI (milsaperidone), for Bipolar I manic episodes and Schizophrenia symptoms. This marks the company's second FDA approval in a short period and provides a long-term revenue moat due to a patent extending until 2044. BYSANTI's development leveraged the trusted safety profile of a related older drug, and it is also being tested for major depressive disorder, potentially expanding its market significantly.
Vanda Pharmaceuticals Receives FDA Approval for BYSANTI™
Vanda Pharmaceuticals announced FDA approval for BYSANTI™ (milsaperidone) as a first-line therapy for acute episodes of bipolar I disorder and schizophrenia in adults. The drug is expected to be commercially available in Q3 2026 and comes with patent protection until 2044. BYSANTI™ is also undergoing further clinical study as an adjunctive treatment for treatment-resistant major depressive disorder.
VNDA Stock Rallies After-Hours As FDA Approves Schizophrenia, Bipolar Disorder Drug
Vanda Pharmaceuticals (VNDA) shares surged 38% after hours following FDA approval of its Bysanti tablets for treating manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults. The drug is expected to be available in Q3 2026. This marks the second FDA approval for Vanda in recent months, despite a setback earlier this year regarding its Hetlioz drug for jet lag.
Vanda Pharmaceuticals Announces FDA Approval of BYSANTI™ (milsaperidone) for the treatment of Bipolar I Disorder and Schizophrenia - A New Chemical Entity Opening New Horizons in Psychiatric Innovation
Vanda Pharmaceuticals announced FDA approval for BYSANTI™ (milsaperidone) tablets, a new chemical entity (NCE), for treating acute manic or mixed episodes associated with bipolar I disorder and schizophrenia in adults. The drug is bioequivalent to iloperidone, leveraging its established efficacy and safety profile. Vanda anticipates commercial availability in Q3 2026, with patent protection expected until 2044.
Vanda Pharmaceuticals (NASDAQ:VNDA) Lowered to "Hold" Rating by Zacks Research
Zacks Research has downgraded Vanda Pharmaceuticals (NASDAQ:VNDA) from a "strong-buy" to a "hold" rating. This adjustment comes amidst mixed analyst sentiments, with several firms maintaining "buy" ratings and raising price targets, while others express caution due to recent earnings misses and near-term profitability concerns. The company currently has a consensus "Hold" rating and an average target price of $13.63, with upcoming FDA decisions potentially impacting its stock.
Vanda Awaits FDA Verdict On Atypical Antipsychotic Bysanti
Vanda Pharmaceuticals is awaiting an FDA decision on February 21, 2026, for its atypical antipsychotic drug candidate, Bysanti. Bysanti, an active metabolite of iloperidone, is intended to treat bipolar I disorder and schizophrenia. An approval would grant five years of regulatory data exclusivity and potentially extend patent protection into the 2040s, while also placing it in competition with other established antipsychotics.
Vanda Awaits FDA Verdict On Atypical Antipsychotic Bysanti
Vanda Pharmaceuticals (VNDA) is anticipating a critical FDA decision on February 21, 2026, for its drug candidate Bysanti, an atypical antipsychotic targeting bipolar I disorder and schizophrenia. If approved, Bysanti would gain five years of regulatory data exclusivity and potentially patent protection into the 2040s, competing with established drugs like Abilify and Invega Sustenna. The stock last closed at $6.10, showing a 1.16% increase, and has traded between $3.81 and $9.60 over the past year.
Vanda Stock Draws Heavy Buzz Ahead Of FDA Verdict On Bysanti For Bipolar, Schizophrenia
Vanda Pharmaceuticals Inc. (VNDA) stock is generating significant retail investor interest as the FDA's decision approaches for Bysanti, its investigational drug for acute bipolar I disorder and schizophrenia. The FDA has set February 21 as the target decision date for the New Drug Application, which Vanda submitted in March 2025. If approved, Bysanti could launch in the U.S. this year, and Vanda is also exploring its use for major depressive disorder.
HC Wainwright Issues Negative Estimate for VNDA Earnings
HC Wainwright has lowered its first-quarter 2026 earnings per share estimate for Vanda Pharmaceuticals (NASDAQ:VNDA) to ($0.57) from ($0.24), while maintaining a "Buy" rating and a $22 price target. This revision follows Vanda's recent report of a ($2.39) loss per share, missing consensus estimates. Analyst opinions on VNDA are mixed, ranging from "Strong Buy" to "Sell," with a consensus target price of $13.63.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Receives Consensus Recommendation of "Moderate Buy" from Analysts
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) has received a consensus "Moderate Buy" rating from analysts, with a target price of $13.63. Despite this, the company missed quarterly earnings expectations, reporting an EPS of ($2.39) against an estimated ($2.18) and revenue of $57.22 million versus $59.28 million, alongside negative profitability metrics. Institutional ownership remains high at 88.14%, reflecting investor interest despite recent financial underperformance and stock volatility.
Vanda Pharmaceuticals (VNDA) Q4 Loss Surge Challenges Bullish Valuation Narratives
Vanda Pharmaceuticals (VNDA) reported its FY 2025 results, showing a significant surge in Q4 losses to US$141 million, despite a modest increase in revenue to US$57.2 million for the quarter. While recent revenue growth is consistent with new product launches, the widening losses, particularly a trailing 12-month loss of US$220.5 million, are challenging bullish valuation narratives based on a low P/S ratio and high DCF fair value. Investors are concerned about the pressure high spending places on future profitability and how the market will respond to deep and persistent losses.
Why did Vanda Pharmaceuticals stock slide 7% pre-market today?
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Vanda Pharmaceuticals (NASDAQ:VNDA) Downgraded to "Sell" Rating by Wall Street Zen
Wall Street Zen downgraded Vanda Pharmaceuticals (NASDAQ:VNDA) to a "Sell" rating from "Hold" following disappointing Q4 results and a cut in FY-2026 revenue guidance. The biopharmaceutical company reported an EPS loss of ($2.39) against a consensus of ($2.18) and revenue of $57.2 million against an expectation of $59.3 million, leading to a revised revenue guidance of $230M–$260M compared to an earlier consensus of $273M. Despite the downgrade, other analysts maintain a "Moderate Buy" average rating with a consensus target of $13.63, and institutional ownership remains high at 88.1%.
Vanda Pharmaceuticals (NASDAQ:VNDA) Raised to "Strong-Buy" at Zacks Research
Zacks Research has upgraded Vanda Pharmaceuticals (NASDAQ:VNDA) to a "Strong-Buy" rating despite a significant stock plunge and recent earnings miss. The upgrade considers positive factors like strong Fanapt sales momentum, the recent NEREUS approval, and an upcoming PDUFA date for Bysanti, which could substantially improve the company's prospects. This positive outlook comes amid mixed analyst sentiment, financial challenges, and an ongoing investor litigation probe.
Why Did Vanda Pharmaceuticals Stock Slide 7% Pre-Market Today?
Vanda Pharmaceuticals' stock declined 7% pre-market after the company filed a shelf registration statement to raise up to $200 million through future securities offerings. This move provides the biotechnology company with financial flexibility but also comes after its Q4 earnings and revenue fell short of analyst expectations, reporting a loss per share of $2.39 despite an 8% year-on-year increase in total net product revenue to $57.2 million. The company projects total revenue for 2026 to be between $230 million and $260 million.
Vanda Pharmaceuticals (VNDA) Q4 Loss Surge Challenges Bullish Valuation Narratives
Vanda Pharmaceuticals (VNDA) reported a significant surge in its Q4 2025 loss per share to US$2.39, with net losses widening sharply to US$141.2 million, despite revenue reaching US$57.2 million. While the company's low price-to-sales ratio (1.7x) and a discounted cash flow fair value of US$65.46 suggest potential upside for bullish investors, the deepening losses and increased share price volatility challenge these optimistic valuation narratives. The article highlights the tension between revenue growth from new products and the negative impact of high SG&A and R&D costs on profitability.
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
Pomerantz LLP is investigating Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) on behalf of investors for potential securities fraud. This investigation follows Vanda's announcement on January 8, 2026, that the FDA could not approve the sNDA for HETLIOZ® for jet lag disorder in its current form, causing Vanda's stock to fall 14.05%. Investors are encouraged to contact Pomerantz LLP for more information.
Vanda Pharmaceuticals’ stock tumbles after $220M loss
Vanda Pharmaceuticals' stock dropped significantly following a report of a $220 million loss. Additionally, the D.C. biotech company filed a shelf registration statement for $200 million, indicating plans to raise capital in the coming years. This financial news has led to investor concern, as reflected in the stock's tumble.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Q4 2025 Earnings Call Transcript
Vanda Pharmaceuticals Inc. reported its Q4 and full-year 2025 financial results, highlighting a 9% increase in total revenues to $216.1 million for 2025, primarily driven by Fanapt sales growth. The company also announced significant regulatory and clinical advancements, including FDA approval for Nereus for motion-induced vomiting and ongoing Phase III trials for several pipeline products. Vanda provided 2026 revenue guidance of $230 million to $260 million for its current commercialized products, expecting continued growth across its portfolio and potential new product approvals.
Vanda Pharmaceuticals Inc Files For Mixed Shelf Offering Of Upto $200 Million - SEC Filing
Vanda Pharmaceuticals Inc. has filed for a mixed shelf offering of up to $200 million, according to an SEC filing. This news was reported by Reuters, indicating a potential capital raise for the pharmaceutical company.
Vanda Pharmaceuticals Inc. SEC 10-K Report
Vanda Pharmaceuticals Inc. has released its 2025 10-K report, revealing a total revenue of $216.1 million, a 9% increase primarily due to Fanapt® sales, but also a significant net loss of $220.5 million. The report details the company's financial performance, commercial portfolio including product launches like NEREUS™, ongoing R&D efforts, and strategic initiatives for pipeline expansion. Key challenges include generic competition for HETLIOZ®, market reliance on core products, and regulatory hurdles.
Earnings call transcript: Vanda Pharmaceuticals Misses Q4 2025 Expectations By Investing.com
Vanda Pharmaceuticals reported a significant miss for Q4 2025, with an adjusted EPS of -$1.81 against a forecast of -$0.98, and revenue of $33.22 million versus an expected $59.28 million. Despite these misses, the stock saw a slight increase in aftermarket trading, and the company highlighted future growth drivers including FDA approval for Nereus, development of Bysanti and Imsidolimab, and expansion of its sales force. The full-year 2025 net loss rose significantly to $220.5 million, partly due to a one-time non-cash income tax charge.
Vanda Pharmaceuticals Inc (NASDAQ:VNDA) Stock Plummets 9.8% After Mixed Q4 2025 Earnings Report
Vanda Pharmaceuticals (NASDAQ:VNDA) reported mixed Q4 2025 earnings, with revenue missing expectations at $57.22 million but a significant earnings beat with a non-GAAP loss per share of $0.46 against an anticipated $1.35 loss. Despite the strong bottom-line performance, the stock plunged 9.8% in after-hours trading due to the revenue miss and concerns about future growth, particularly given projections for continued losses through 2026. The market's negative reaction highlights investor apprehension regarding the company's forward-looking prospects despite cost control efforts.
Vanda: Q4 Financial Results Overview
Vanda Pharmaceuticals reported a net loss of $141.2 million, or $2.39 per share, in the fourth quarter, with revenues of $57.2 million. For the full year, the company's total loss reached $220.5 million, or $3.74 per share, on annual revenues of $216.1 million. The article provides a brief overview of the company's financial performance.
Vanda: Q4 Earnings Snapshot
Vanda Pharmaceuticals Inc. (VNDA) reported a significant loss of $141.2 million in its fourth quarter, translating to $2.39 per share, or an adjusted loss of 46 cents per share. The biopharmaceutical company posted revenues of $57.2 million for the quarter. For the full year, Vanda incurred a loss of $220.5 million with total revenues of $216.1 million.
Vanda Pharmaceuticals (VNDA) Reports Q4 Loss, Lags Revenue Estimates
Vanda Pharmaceuticals (VNDA) reported a narrower-than-expected Q4 loss of $0.46 per share, beating the Zacks Consensus Estimate of a $2.18 loss. However, the biopharmaceutical company's revenues of $57.22 million missed the consensus estimate by 2.78%. Despite the earnings beat, Vanda's stock has underperformed the S&P 500 year-to-date, but its favorable earnings estimate revision trend currently translates to a Zacks Rank #2 (Buy).
Vanda: Q4 Earnings Snapshot
Vanda Pharmaceuticals Inc. reported a significant loss of $141.2 million in its fourth quarter, translating to a loss of $2.39 per share, or 46 cents per share when adjusted for non-recurring costs. The biopharmaceutical company generated $57.2 million in revenue for the quarter. For the full year, Vanda recorded a total loss of $220.5 million ($3.74 per share) on revenues of $216.1 million.
Vanda Pharmaceuticals to Announce Fourth Quarter and Full Year 2025 Financial Results on February 11, 2026
Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced it will release its fourth quarter and full year 2025 financial results on Wednesday, February 11, 2026, after market close. The company will host a conference call and webcast at 4:30 PM ET on the same day to discuss the results and other corporate activities. Investors can access the webcast on Vanda's website, and a replay will be available until February 18, 2026.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Short Interest Up 23.3% in January
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) experienced a significant 23.3% increase in short interest in January, reaching 2,879,747 shares, which represents 5.3% of its stock. Despite this, institutional ownership remains high at 88.14%, with several hedge funds notably increasing their stakes. Wall Street analysts maintain a "Moderate Buy" rating with an average price target of $13.63, while the stock trades around $7.74.
Biggest stock movers Wednesday: Vanda Pharmaceuticals, Axsome Therapeutics and Cybin
This article lists the biggest stock movers on a Wednesday, highlighting Vanda Pharmaceuticals, Axsome Therapeutics, and Cybin as companies with significant stock movement. The content provided is minimal, essentially serving as a headline for stock market activity. Further details on why these stocks moved are not available in this snippet.
Vanda Pharmaceuticals Inc. (VNDA): Investor Outlook Reveals 77% Potential Upside
Vanda Pharmaceuticals Inc. (VNDA) is a biopharmaceutical company with a promising product pipeline and a market capitalization of $454.45 million. Analysts suggest a potential upside of 77.18%, with an average target price of $13.63, driven by its strong revenue growth of 18.10%. Despite current losses and negative ROE, the company's commitment to R&D and innovative therapies makes it an attractive long-term investment for risk-tolerant investors.
Can Bysanti Redefine Vanda's Commercial Portfolio?
Vanda Pharmaceuticals Inc. is awaiting an FDA decision on its investigational drug Bysanti, expected on February 21, 2026, for acute bipolar I disorder and schizophrenia. If approved, Bysanti could offer extended market protection into the 2040s, providing a strategic advantage over its current drug, Fanapt, which faces patent expiration. The company is also developing Imsidolimab for generalized pustular psoriasis and expects results for Bysanti in major depressive disorder later in 2026, alongside reporting its full-year 2025 financial results.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) Receives Average Rating of "Moderate Buy" from Analysts
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) has received a "Moderate Buy" consensus rating from six analysts, with an average 1-year price target of $13.63. Despite missing recent quarterly earnings and revenue estimates and showing negative financials, the biopharmaceutical company is heavily owned by institutional investors, who have recently increased their stakes. Vanda Pharmaceuticals is focused on developing therapies for central nervous system disorders and rare diseases.
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
Pomerantz LLP is investigating potential securities fraud claims against Vanda Pharmaceuticals Inc. following a significant drop in its stock price. This investigation comes after the U.S. FDA declined to approve Vanda's supplemental New Drug Application for HETLIOZ® for jet lag disorder, due to concerns that the clinical trial protocols did not sufficiently mimic actual jet travel conditions. Investors are advised to contact the firm regarding their legal rights.
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
Pomerantz LLP is investigating potential securities fraud claims against Vanda Pharmaceuticals Inc. following a significant drop in its stock price. The investigation comes after the FDA declined to approve Vanda's supplemental New Drug Application for HETLIOZ® (tasimelteon) for jet lag, citing insufficient evidence of effectiveness for real-world travel conditions. Shareholders who experienced losses are encouraged to contact the firm.
Millennium Management LLC Reduces Stake in Vanda Pharmaceuticals Inc
Millennium Management LLC significantly reduced its stake in Vanda Pharmaceuticals Inc. by 48.35% on December 31, 2025, selling 1,571,823 shares at $8.82 each. The firm's decision may stem from Vanda Pharmaceuticals being overvalued with negative growth indicators, a GF Value of $5.21 against its current trading price of $7.45. This move minimally impacted Millennium Management's portfolio, reflecting a strategic adjustment to perceived risks in the biotechnology company.
VNDA: Imminent launches and label expansions position the portfolio for major near-term growth
Vanda Pharmaceuticals Inc. (VNDA) is poised for significant near-term growth, driven by upcoming catalysts such as Bysanti's PDUFA in February 2026 and the commercial launch of NEREUS. The company also anticipates substantial expansion through new indications, specifically in areas like motion sickness, GLP-1, and Major Depressive Disorder (MDD). This outlook was highlighted during the 44th Annual J.P. Morgan Healthcare Conference.
Lost Money on Vanda Pharmaceuticals Inc. (VNDA)? Contact Levi & Korsinsky About Fraud Investigation
Levi & Korsinsky has initiated an investigation into Vanda Pharmaceuticals Inc. (VNDA) following a significant stock price drop. This comes after the FDA rejected Vanda's supplemental New Drug Application for HETLIOZ® for jet lag disorder, citing that clinical trial protocols were not sufficiently analogous to actual jet travel conditions. Investors who incurred losses on Vanda Pharmaceuticals Inc. securities are encouraged to contact Levi & Korsinsky for a potential recovery under federal securities laws.
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
Pomerantz LLP is investigating Vanda Pharmaceuticals Inc. (VNDA) following a significant drop in stock price. The investigation comes after the U.S. FDA declined to approve Vanda's supplemental New Drug Application for HETLIOZ® for jet lag disorder, due to concerns that controlled trials did not sufficiently replicate actual jet travel conditions. Vanda's stock fell 14.05% after this announcement.
Pomerantz Law Firm Investigates Claims On Behalf of Investors of Vanda Pharmaceuticals Inc. - VNDA
Pomerantz Law Firm is investigating potential claims on behalf of investors of Vanda Pharmaceuticals Inc. (VNDA). The article indicates this investigation is related to claims made against the company. No specific details about the nature of the claims are provided in the current content.
Vanda (VNDA) May Find a Bottom Soon, Here's Why You Should Buy the Stock Now
Vanda Pharmaceuticals (VNDA) stock, despite a recent 5.8% loss, shows signs of a potential reversal due to the formation of a hammer chart pattern, indicating subsiding selling pressure. This technical signal, combined with an upward trend in earnings estimate revisions from Wall Street analysts and a Zacks Rank #2 (Buy), suggests a bullish outlook for the biopharmaceutical company. The article explains the hammer chart pattern and emphasizes using it with other bullish indicators, while also highlighting the significance of positive earnings estimate revisions for VNDA's near-term price appreciation.
FDA rejects Vanda's jet lag drug application days after approving motion sickness drug
Vanda Pharmaceuticals, a D.C.-based drugmaker, had its jet lag drug application rejected by the FDA for the second time, just a week after securing FDA approval for a motion sickness treatment. This rejection marks a setback for the company despite a recent court ruling that had revived its chances for key drug approval. The company is led by Dr. Mihael Polymeropoulos.
Vanda Pharmaceuticals stock falls after FDA rejects jet lag treatment application
Vanda Pharmaceuticals' stock dropped 12% after the FDA rejected its application for HETLIOZ to treat jet lag disorder, despite acknowledging positive efficacy from Vanda's trials. The FDA cited that the controlled phase advance protocols were not analogous enough to real jet travel conditions. Vanda Pharmaceuticals disagreed with the FDA's interpretation, maintaining that its data should meet the efficacy standards.
Vanda Pharmaceuticals Inc Receives FDA Decision on HETLIOZ® sNDA for Jet Lag
Vanda Pharmaceuticals Inc. announced on January 8, 2026, that the FDA did not approve its sNDA for HETLIOZ® for jet lag disorder due to a lack of substantial evidence of effectiveness. The FDA concluded that the controlled trials' phase advance models were not analogous to actual travel, a point with which Vanda disagrees, citing the validity of these models in circadian rhythm research. Vanda plans to continue working with the FDA for approval.
Vanda Pharmaceuticals Announces Receipt of FDA Decision Letter on HETLIOZ® Supplemental New Drug Application for Jet Lag Disorder
Vanda Pharmaceuticals announced that the FDA has issued a decision letter concluding that the supplemental New Drug Application for HETLIOZ® for jet lag disorder cannot be approved in its current form. While the FDA acknowledged positive efficacy from Vanda's trials, it concluded that the data did not provide substantial evidence of effectiveness because the phase advance protocols were not considered sufficiently analogous to actual jet travel conditions. Vanda respectfully disagrees and maintains that the submitted data meets the statutory standard for effectiveness.
Vanda Pharmaceuticals stock price target raised to $22 by H.C. Wainwright
H.C. Wainwright raised its price target for Vanda Pharmaceuticals to $22 from $20, maintaining a Buy rating, following FDA approval of NEREUS (tradipitant) for motion-induced vomiting. This approval marks the first new pharmacological treatment for motion sickness in over four decades and represents a significant milestone for the company, which also has other drugs in its pipeline receiving positive analyst attention. Despite not being profitable in the past year, Vanda shows strong gross profit margins and expected net income growth.
FDA Grants Approval to Vanda Pharma’s Motion Sickness Medication, Boosting Growth Potential
The FDA has approved Vanda Pharmaceuticals' Nereus (tradipitant) for motion sickness, marking the first new medication in over 40 years. This decision has led to revised price targets from analysts, with HC Wainwright, B Riley Securities, and Cantor Fitzgerald maintaining Buy/Outperform ratings, while Jefferies holds a Neutral stance. Clinical trials demonstrated Nereus's effectiveness in significantly reducing vomiting, and the drug also shows potential for managing GLP-1 therapy-induced nausea.
Vanda Pharmaceuticals Says FDA Will Take More Time To Decide On Tradipitant Clinical Hold Re-Review
Vanda Pharmaceuticals announced that the FDA requires more time to review the company's appeal regarding the clinical hold on its tradipitant program. The FDA issued the hold based on certain findings from a nonclinical toxicology study with similar compounds. Vanda asserts that it has adequately addressed these concerns and believes the FDA's decision is without scientific merit.
