Vanda Pharmaceuticals Stock (NASDAQ: VNDA)

Vanda Pharmaceuticals (NASDAQ:VNDA) Stock

Vanda Pharmaceuticals

Vanda Pharma

Vanda Pharmaceuticals Inc is a biopharmaceutical company engaged in the development and commercialization of therapies to address high unmet medical needs and improve the lives of patients. Its commercial portfolio comprises three products; HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) & nighttime sleep disturbances in Smith-Magenis Syndrome (SMS); Fanapt for the treatment of schizophrenia; and PONVORY. Its other products include VHX-896, ASO Molecules, VQW-765, Tradipitant, VTR-297 and VHX-896. The majority of revenue is derived from the Fanapt product sales. Geographically, the company sells its product predominantly in the United States, and also in Israel, Europe, and Canada.

VNDA

Biotech

News

Health Care

General

FDA denies Vanda&#39;s Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the agency&#39;s review process.

FDA Unveils Grounds For Rejecting Vanda Pharmaceuticals Stomach Paralysis Candidate

Analyst Color

Price Target

Initiation

Analyst Ratings

Trading Ideas

HC Wainwright initiates Buy on Vanda Pharmaceuticals with an $18 price target, citing undervaluation, a strong product portfolio, and growth in neurology.

Over 200% Stock Upside - Vanda Pharmaceuticals Undervalued With Robust Portfolio And Pipeline: Analyst

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Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced that the FDA issued a complete response letter to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis.

VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis

Vanda Pharmaceuticals Inc. - Common Stock

Vanda Pharmaceuticals Inc

Ratings for Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) were provided by 5 analysts in the past three months, showcasing a mix of bullish and bearish perspectives.
The following table summarizes their recent ratings, shedding light on the changing sentiments within the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">5</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">3</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
In the assessment of 12-month price targets, analysts unveil insights for Vanda Pharma, presenting an average target of $18.4, a high estimate of $20.00, and a low estimate of $18.00. This upward trend is evident, with the current average reflecting a 2.22% increase from the previous average price target of $18.00.
<img src="https://www.benzinga.com/files/images/story/2025/1739880054_0.png" alt="price target chart" />
<h2>Investigating Analyst Ratings: An Elaborate Study</h2>
An in-depth analysis of recent analyst actions unveils how financial experts perceive Vanda Pharma. The following summary outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Raises</td>
<td>Buy</td>
<td>$20.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts respond to changes in market conditions and company performance, frequently updating their recommendations. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to Vanda Pharma. This information offers a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Delving into assessments, analysts assign qualitative values, from 'Outperform' to 'Underperform'. These ratings communicate expectations for the relative performance of Vanda Pharma compared to the broader market.</li>
<li>Price Targets: Analysts navigate through adjustments in price targets, providing estimates for Vanda Pharma's future value. Comparing current and prior targets offers insights into analysts' evolving expectations.</li>
</ul>
Analyzing these analyst evaluations alongside relevant financial metrics can provide a comprehensive view of Vanda Pharma's market position. Stay informed and make data-driven decisions with the assistance of our Ratings Table.
<a href="https://www.benzinga.com/quote/VNDA/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Vanda Pharma analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>Discovering Vanda Pharma: A Closer Look</h2>
Vanda Pharmaceuticals Inc is a biopharmaceutical company engaged in the development and commercialization of therapies to address high unmet medical needs and improve the lives of patients. Its commercial portfolio comprises three products, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) &amp; nighttime sleep disturbances in Smith-Magenis Syndrome (SMS), Fanapt for the treatment of schizophrenia and PONVORY. Its other products include VHX-896, ASO Molecules, VQW-765, Tradipitant, VTR-297 and VHX-896. The majority of revenue is derived from HETLIOZ product sales.
<h3>Vanda Pharma's Economic Impact: An Analysis</h3>
Market Capitalization Analysis: With a profound presence, the company's market capitalization is above industry averages. This reflects substantial size and strong market recognition.
Revenue Growth: Vanda Pharma's remarkable performance in 3 months is evident. As of 30 September, 2024, the company achieved an impressive revenue growth rate of 22.76%. This signifies a substantial increase in the company's top-line earnings. When compared to others in the Health Care sector, the company faces challenges, achieving a growth rate lower than the average among peers.
Net Margin: The company's net margin is a standout performer, exceeding industry averages. With an impressive net margin of -11.17%, the company showcases strong profitability and effective cost control.
Return on Equity (ROE): Vanda Pharma's ROE surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive -0.98% ROE, the company effectively utilizes shareholder equity capital.
Return on Assets (ROA): Vanda Pharma's ROA excels beyond industry benchmarks, reaching -0.82%. This signifies efficient management of assets and strong financial health.
Debt Management: Vanda Pharma's debt-to-equity ratio is below the industry average at 0.01, reflecting a lower dependency on debt financing and a more conservative financial approach.
<h2>How Are Analyst Ratings Determined?</h2>
Benzinga tracks 150 analyst firms and reports on their stock expectations. Analysts typically arrive at their conclusions by predicting how much money a company will make in the future, usually the upcoming five years, and how risky or predictable that company's revenue streams are.
Analysts attend company conference calls and meetings, research company financial statements, and communicate with insiders to publish their ratings on stocks. Analysts typically rate each stock once per quarter or whenever the company has a major update.
Some analysts will also offer forecasts for metrics like growth estimates, earnings, and revenue to provide further guidance on stocks. Investors who use analyst ratings should note that this specialized advice comes from humans and may be subject to error.
Which Stocks Are Analysts Recommending Now?
Benzinga Edge gives you instant access to all major analyst upgrades, downgrades, and price targets. Sort by accuracy, upside potential, and more. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=be8be9arja3be22bz21&amp;utm_source=benzinga-insights">Click here to stay ahead of the market</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

The Analyst Verdict: Vanda Pharma In The Eyes Of 5 Experts

HC Wainwright &amp; Co. analyst Raghuram Selvaraju maintains Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) with a Buy and raises the price target from $18 to $20.

HC Wainwright & Co. Maintains Buy on Vanda Pharma, Raises Price Target to $20

Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) sees FY2025 sales of $210.000 million-$250.000 million vs $284.90 million analyst estimate.

Guidance

Vanda Pharma Sees FY2025 Sales $210.000M-$250.000M vs $284.90M Est

Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) reported quarterly losses of $(0.08) per share which beat the analyst consensus estimate of $(0.11) by 27.27 percent. This is a 100 percent decrease over losses of $(0.04) per share from the same period last year. The company reported quarterly sales of $53.19 million which beat the analyst consensus estimate of $52.25 million by 1.79 percent. This is a 17.48 percent increase over sales of $45.27 million the same period last year.

Vanda Pharma Q4 EPS $(0.08) Beats $(0.11) Estimate, Sales $53.19M Beat $52.25M Estimate

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Earnings Scheduled For February 13, 2025

HC Wainwright &amp; Co. analyst Raghuram Selvaraju reiterates Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) with a Buy and maintains $18 price target.

Reiteration

HC Wainwright & Co. Reiterates Buy on Vanda Pharma, Maintains $18 Price Target

ANAB

Vanda Pharmaceuticals And Anaptys Announce Exclusive Global License Agreement For Imsidolimab; Anaptys To Receive $15M Upfront And 10% Royalty On Global Sales

Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) has been analyzed by 4 analysts in the last three months, revealing a diverse range of perspectives from bullish to bearish.
The table below summarizes their recent ratings, showcasing the evolving sentiments within the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">4</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
Analysts provide deeper insights through their assessments of 12-month price targets, revealing an average target of $18.0, a high estimate of $18.00, and a low estimate of $18.00. No alteration is observed as the current average remains at the previous average price target. 
<img src="https://www.benzinga.com/files/images/story/2025/1738069290_0.png" alt="price target chart" />
<h2>Analyzing Analyst Ratings: A Detailed Breakdown</h2>
The standing of Vanda Pharma among financial experts becomes clear with a thorough analysis of recent analyst actions. The summary below outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Maintains</td>
<td>Buy</td>
<td>$18.00</td>
<td>$18.00</td>
</tr>
<tr>
<td>Raghuram Selvaraju</td>
<td>HC Wainwright &amp; Co.</td>
<td>Announces</td>
<td>Buy</td>
<td>$18.00</td>
<td>-</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: In response to dynamic market conditions and company performance, analysts update their recommendations. Whether they 'Maintain', 'Raise', or 'Lower' their stance, it signifies their reaction to recent developments related to Vanda Pharma. This insight gives a snapshot of analysts' perspectives on the current state of the company.</li>
<li>Rating: Unveiling insights, analysts deliver qualitative insights into stock performance, from 'Outperform' to 'Underperform'. These ratings convey expectations for the relative performance of Vanda Pharma compared to the broader market.</li>
<li>Price Targets: Analysts explore the dynamics of price targets, providing estimates for the future value of Vanda Pharma's stock. This examination reveals shifts in analysts' expectations over time.</li>
</ul>
Assessing these analyst evaluations alongside crucial financial indicators can provide a comprehensive overview of Vanda Pharma's market position. Stay informed and make well-judged decisions with the assistance of our Ratings Table.
<a href="https://www.benzinga.com/quote/VNDA/analyst-ratings?utm_source=Benzinga Insights">Stay up to date on Vanda Pharma analyst ratings.</a>
If you are interested in following small-cap stock news and performance <a href="https://www.benzinga.com/news/small-cap">you can start by tracking it here</a>.
<h2>Discovering Vanda Pharma: A Closer Look</h2>
Vanda Pharmaceuticals Inc is a biopharmaceutical company engaged in the development and commercialization of therapies to address high unmet medical needs and improve the lives of patients. Its commercial portfolio comprises three products, HETLIOZ for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) &amp; nighttime sleep disturbances in Smith-Magenis Syndrome (SMS), Fanapt for the treatment of schizophrenia and PONVORY. Its other products include VHX-896, ASO Molecules, VQW-765, Tradipitant, VTR-297 and VHX-896. The majority of revenue is derived from HETLIOZ product sales.
<h3>Key Indicators: Vanda Pharma's Financial Health</h3>
Market Capitalization: Boasting an elevated market capitalization, the company surpasses industry averages. This signals substantial size and strong market recognition.
Revenue Growth: Over the 3 months period, Vanda Pharma showcased positive performance, achieving a revenue growth rate of 22.76% as of 30 September, 2024. This reflects a substantial increase in the company's top-line earnings. When compared to others in the Health Care sector, the company faces challenges, achieving a growth rate lower than the average among peers.
Net Margin: Vanda Pharma's financial strength is reflected in its exceptional net margin, which exceeds industry averages. With a remarkable net margin of -11.17%, the company showcases strong profitability and effective cost management.
Return on Equity (ROE): The company's ROE is a standout performer, exceeding industry averages. With an impressive ROE of -0.98%, the company showcases effective utilization of equity capital.
Return on Assets (ROA): Vanda Pharma's ROA surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive -0.82% ROA, the company effectively utilizes its assets for optimal returns.
Debt Management: Vanda Pharma's debt-to-equity ratio is below the industry average at 0.01, reflecting a lower dependency on debt financing and a more conservative financial approach.
<h2>Analyst Ratings: What Are They?</h2>
Benzinga tracks 150 analyst firms and reports on their stock expectations. Analysts typically arrive at their conclusions by predicting how much money a company will make in the future, usually the upcoming five years, and how risky or predictable that company's revenue streams are.
Analysts attend company conference calls and meetings, research company financial statements, and communicate with insiders to publish their ratings on stocks. Analysts typically rate each stock once per quarter or whenever the company has a major update.
Beyond their standard evaluations, some analysts contribute predictions for metrics like growth estimates, earnings, and revenue, furnishing investors with additional guidance. Users of analyst ratings should be mindful that this specialized advice is shaped by human perspectives and may be subject to variability.
Which Stocks Are Analysts Recommending Now?
Benzinga Edge gives you instant access to all major analyst upgrades, downgrades, and price targets. Sort by accuracy, upside potential, and more. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=be8be9arja3be22bz21&amp;utm_source=benzinga-insights">Click here to stay ahead of the market</a>.
This article was generated by Benzinga's automated content engine and reviewed by an editor.

A Glimpse Into The Expert Outlook On Vanda Pharma Through 4 Analysts

Vanda Pharmaceuticals Accepts FDA's Offer Of Opportunity For Hearing On New Drug Application For Tradipitant In Gastroparesis

The Director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA) issued a notice summarizing the grounds for refusing a new drug application (NDA) submitted by Vanda Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) for Tradipitant for symptoms in gastroparesis.
The <a target="_blank" href="https://public-inspection.federalregister.gov/2025-01027.pdf" rel="noreferrer noopener">notice</a> offers Vanda an opportunity to request a hearing on the matter.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/11/41692641/over-200-stock-upside-vanda-pharmaceuticals-undervalued-with-robust-portfolio-and-p" rel="noreferrer noopener">Over 200% Stock Upside &#8211; Vanda Pharmaceuticals Undervalued With Robust Portfolio And Pipeline: Analyst</a>
In September, the FDA issued a Complete Response Letter to the company. The agency disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40941051/fda-strikes-off-vanda-pharmaceuticals-tradipitant-for-stomach-paralysis-asks-for-additional-studi" rel="noreferrer noopener">course of the disorder</a>.&nbsp;
Last week, Vanda Pharmaceuticals wrote a letter to the FDA Commissioner highlighting faulty <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/n42886503/vandas-letter-to-fda-commissioner-highlights-faulty-gastroparesis-nda-review" rel="noreferrer noopener">gastroparesis NDA review</a>.
The FDA identified:
<ul>
<li>In the 3301 Phase 3 Study (Group 1), the drug did not show a statistically significant improvement over placebo for nausea severity or other gastroparesis symptoms. Secondary measures results also lacked meaningful differences and sometimes even favored the placebo.</li>
<li>2301 Phase 2 Study: While it showed significant results for nausea at Week 4, the study had methodological flaws and inadequate data handling, reducing the reliability of its findings. Additionally, Study 3301 failed to confirm the results of Study 2301.</li>
<li>Confirmatory Evidence: Post hoc analyses and pooled data from the studies were insufficient to support efficacy claims. Other sources, such as open-label studies and unrelated motion sickness trials, could not confirm the drug&#8217;s effectiveness.</li>
<li>Safety: Data from trials were limited to 12 weeks, which is inadequate for a chronic condition like gastroparesis that requires long-term treatment. Animal and lab studies did not provide enough information to assess long-term safety risks for humans.</li>
</ul>
The FDA recommended conducting two new, well-designed clinical trials in adults with idiopathic or diabetic gastroparesis to address the deficiencies and perform a long-term toxicity study in a non-rodent species.
Vanda could either resubmit the application addressing all deficiencies, withdraw the application, or request a hearing.
In November 2024, Vanda received a formal notice of opportunity for a hearing.
Price Action: VNDA stock is down 2.45% at $4.34 at the last check on Thursday.
Read Next:
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<li><a href="https://www.benzinga.com/news/large-cap/25/01/43028181/chemical-company-dupont-electronics-business-separation-retains-water-business" target="_blank" rel="noreferrer noopener">Chemical Company DuPont Accelerates Electronics Business Separation, Retains Water Business</a></li>
</ul>

Dear Dr.&nbsp;Califf:
We are writing to bring your attention to a disturbing pattern of conduct at FDA that impairs the credibility of the agency and harms the American public. In an interview last year you stated that you would not overrule decisions made by civil servants at the Agency except in certain cases of "corruption" or "temporary insanity" of the decision maker.1&nbsp;Neither the public nor regulated entities like Vanda are able to determine what instances of "corruption" or "temporary insanity" would in your view merit overruling lower-level FDA employee decisions. This opacity in decisionmaking and oversight has allowed a culture of obfuscation and closemindedness to fester at FDA. And your agency's review of our application to market tradipitant is no exception.
Three months ago, Vanda received a complete response letter (CRL), dated September 18, 2024, in response to the new drug application (NDA) Vanda submitted on September 18, 2023, for the use of tradipitant for the treatment of symptoms of gastroparesis, a serious and debilitating gastrointestinal disorder. We wrote to Dr. Nikolov expressing our surprise "by the sheer disregard for the facts, evidence, and basic scientific principles contained in the complete response"—a letter that could not "possibly reflect a legitimate regulatory review" as it did not "provide reasoned explanations or engage with the evidence we presented on its merit—including voluminous evidence from experts."
Three months later, Dr. Nikolov has not even acknowledged that letter, let alone provided a response. This is unacceptable, and stems from the seriously misguided nature of your position that you will not overrule decisions made by civil servants at the Agency except in extreme situations such as "corruption" or "temporary insanity" of the decision maker. As a political appointee and head of the agency, you are the only person accountable to the American public—a public that needs to know that the agency will follow the law and ensure courteous and civil behavior by agency employees.
In addition, FDA has denied our request to convene an Advisory Committee to consider our application for tradipitant, a process by which experts and the public can voice their opinion on our application. As you are no doubt aware, the number of Advisory Committee meetings convened by the agency has drastically declined over the last few years.&nbsp;See Cheri Banks, The Future of Voting for FDA Advisory Committees, Federation of American Scientists (Sept. 9, 2024), perma.cc/L8R3-2FJD (noting that in 2021, 6% of drug applications were referred to advisory committees, down from 55% in 2010). You have stated separately that there should be "less voting" by advisory committees, and that you don't believe in "gladiator votes" because "votes don't matter."&nbsp; These statements compound a sentiment that the agency avoids public scrutiny of its decisions, which is dangerous both for public health and agency credibility.
I understand that you may be leaving the agency in the new administration, but I hope that you will consider this letter, and I would welcome your thoughts in response. FDA's policies, practices, and culture must be evaluated and corrected so as to align with scientific evidence and the law.
Sincerely,
Mihael H. Polymeropoulos, M.D. Chief Executive Officer Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Pens Letter To FDA Commissioner Regarding Approval For Tradipitant For Treatment Of Patients With Gastroparesis

Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) reported quarterly losses of $(0.09) per share which beat the analyst consensus estimate of $(0.17) by 47.06 percent. The company reported quarterly sales of $47.651 million which missed the analyst consensus estimate of $49.155 million by 3.06 percent. This is a 22.76 percent increase over sales of $38.815 million the same period last year.

Earnings Misses

Vanda Pharma Q3 2024 GAAP EPS $(0.09) Beats $(0.17) Estimate, Sales $47.651M Miss $49.155M Estimate

Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) raises FY2024 sales outlook from $180.00 million-210.00 million to $190.00 million-210.00 million.

Vanda Pharma Raises FY2024 Sales Guidance from $180.00M-210.00M to $190.00M-210.00M

HC Wainwright initiated coverage on Vanda Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>), a commercial-stage biopharmaceutical firm primarily focusing on neurological and neuropsychiatry disorders.
HC Wainwright sees Vanda as having a well-established commercial portfolio, with multiple line extensions and life cycle management opportunities across its three key <a target="_blank" href="https://www.vandapharma.com/pipeline/" rel="noreferrer noopener">franchises</a>: Fanapt, Hetlioz, and Ponvory.
The analyst notes a pipeline of promising programs with numerous opportunities for significant clinical and regulatory milestones expected over the next 6 to 18 months.
Vanda trades at a nearly 30% discount to its cash reserves, giving it a negative enterprise value—a surprising valuation given its strong sales and projected profitability runway through late 2026, even if only some of its clinical and commercial projects succeed.
HC Wainwright initiates with a Buy rating with a <a target="_blank" href="https://www.benzinga.com/quote/VNDA/analyst-ratings" rel="noreferrer noopener">price target of $18</a>.
Vanda's value proposition, however, has been obscured by the ongoing generic competition within its sleep disorder portfolio centered around Hetlioz (tasimelteon) and a recent FDA Complete Response Letter (CRL) for <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40941051/fda-strikes-off-vanda-pharmaceuticals-tradipitant-for-stomach-paralysis-asks-for-additional-studi" rel="noreferrer noopener">tradipitant in gastroparesis</a>, the analyst notes.
Hetlioz, while forecast to bring in about $75 million in 2024 sales, is assumed to decline post-2028; however, ongoing litigation could slow generic entry, and Vanda may expand tasimelteon's indications.
In October, Cycle Pharmaceuticals reaffirmed its proposal to acquire Vanda Pharmaceuticals for an all-cash consideration <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/b41311272/cycle-pharmaceuticals-reaffirms-all-cash-proposal-to-acquire-vanda-pharmaceuticals-for-8-00-per-sh" rel="noreferrer noopener">of $8.00 per share</a>.
However, Vanda declined to accept the offer.
Earlier this year, Future Pak withdrew its&nbsp;proposal to <a target="_blank" href="https://www.benzinga.com/markets/equities/24/06/39530573/whats-going-on-with-vanda-pharmaceuticals-shares-today" rel="noreferrer noopener">purchase the company</a>.
The analyst says past M&amp;A offers indicate that Vanda is intrinsically undervalued and may become an attractive M&amp;A target for one or more mid-size pharmaceutical firms if its near—and medium-term pipeline and product portfolio initiatives are successful.
"Given the negative enterprise value at which Vanda trades despite the continued traction of its marketed products and the risk-mitigated nature of its pipeline and LCM initiatives, we find it difficult to visualize substantial downside risk from current levels," HC Wainwright says.
Price Action: VNDA stock is up 0.87% at $4.69 at the last check on Friday.
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HC Wainwright &amp; Co. analyst Raghuram Selvaraju initiates coverage on Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) with a Buy rating and announces Price Target of $18.

HC Wainwright & Co. Initiates Coverage On Vanda Pharma with Buy Rating, Announces Price Target of $18

Board Has Determined That Latest Proposal Is Not in the Best Interests of the Company or Stockholders
WASHINGTON, Oct. 14, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) today confirmed that it received a second unsolicited, non-binding proposal from Cycle Group Holdings Ltd. ("Cycle Group") to acquire the Company for $8.00 per share in cash.
Cycle Group's second proposal was received by&nbsp;Vanda&nbsp;on&nbsp;September 23, 2024.&nbsp;The terms of Cycle Group's proposal are economically identical to the previously evaluated and rejected indication of interest received from Cycle Group on May 24, 2024. Consistent with its fiduciary duties and in consultation with its independent legal and financial advisors, Vanda's Board of Directors carefully reviewed the second proposal and unanimously determined that it substantially undervalues Vanda and is not in the best interests of the Company and its stockholders. Accordingly, the Board has determined not to pursue the proposal.
The Vanda Board again evaluated all aspects of Vanda's business and compared Vanda's prospects for creating stockholder value to the unsolicited proposal. The Board concluded that the latest proposal from Cycle Group is another opportunistic attempt to purchase the Company's shares at a discount to Vanda's intrinsic value. As part of this process, the Board updated its analysis of the Company's clinical development pipeline, expanding commercial presence and significant cash balance.
The Board and management team remain confident that Vanda's growth profile, strong cash position and efficient operations position the Company well for significant long-term value creation far in excess of the consideration offered by Cycle Group.
There is no action for stockholders to take at this time.

Vanda Pharmaceuticals Confirms Receipt Of Unsolicited $8.00 Per Share Acquisition Proposal From Cycle Group, Board Declares It Not In Best Interests Of Company Or Stockholders

WIIM

Vanda Pharmaceuticals shares are trading higher after Cycle Pharmaceuticals reaffirmed its proposal to acquire the company for $8.00 per share in cash.

Cycle Pharmaceuticals Reaffirms Proposal To Acquire Vanda Pharmaceuticals For $8.00 Per Share In Cash

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