Dernières nouvelles pour Vanda Pharma (NASDAQ:VNDA) Stock

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 HETLIOZ product sales.

Vanda Pharmaceuticals

Vanda Pharmaceuticals Inc. - Common Stock

Vanda Pharmaceuticals Inc

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:
<ul>
<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>

Biotech

News

Health Care

General

VNDA

FDA Unveils Grounds For Rejecting Vanda Pharmaceuticals Stomach Paralysis Candidate

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

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.

Price Target

Reiteration

Analyst Ratings

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

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

Earnings Beats

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.

Guidance

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.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/news/24/11/41688837/apple-satellite-connectivity-provider-globalstar-stock-surges-after-deal-extension" target="_blank" rel="noreferrer noopener">Apple Satellite Connectivity Provider Globalstar Stock Surges After Deal Extension</a></li>
</ul>

Analyst Color

Initiation

Trading Ideas

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

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.

Management

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

Vanda Pharmaceuticals Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/vnda#NASDAQ">VNDA</a>) announced that the FDA issued a complete response letter&nbsp;to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis.
Shares of the company were down 6.1% on Sept. 19 following the announcement of the news.
Marked by delayed gastric emptying, gastroparesis is a serious condition that slows down the stomach&#39;s ability to empty its contents. The FDA has not approved any effective medicine for treating gastroparesis in more than 40 years.
Year to date, shares of Vanda have increased 10.2% compared with the industry&#39;s rise of 0.4%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/4a/78570.jpg?v=840412258" />
Image Source: Zacks Investment Research
<h2>More on FDA&#39;s CRL for VNDA&#39;s Tradipitant</h2>
Per the CRL, the FDA called for Vanda to conduct additional studies on tradipitant with a design that was inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding of the disease.
Also, per management, the FDA delayed its decision by more than 185 days and failed to meet the requirements specified by the Food Drug and Cosmetic Act (FDCA).
Notably, the FDCA requires that the FDA review an NDA and provide either an approval or a possible hearing within 180 days of the filing. The FDA failed to do either.
Per the company, it had time and again asked the FDA to hold an advisory committee meeting to discuss the NDA for tradipitant while the regulatory body declined.
Several patients treated with tradipitant have now filed a Citizen Petition pleading with the regulatory body to approve tradipitant for the treatment of gastroparesis.
<h2>VNDA&#39;s Development Plans for Tradipitant</h2>
Despite the FDA declining to approve tradipitant for treating symptoms in gastroparesis, the company will continue to pursue the marketing approval for tradipitant in the given indication.
Apart from gastroparesis, VNDA is also developing tradipitant for preventing vomiting induced by motion sickness.
In May 2024, the company announced positive data from a second phase III study that investigated tradipitant for preventing vomiting induced by motion sickness.
Vanda plans to submit an NDA for tradipitant to the FDA for the treatment of motion sickness later in 2024.
<h2>Zacks Rank &amp; Stocks to Consider</h2>
Vanda currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Illumina, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/ilmn#NASDAQ">ILMN</a>), Krystal Biotech, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/krys#NASDAQ">KRYS</a>) and Fulcrum Therapeutics, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/fulc#NASDAQ">FULC</a>), each sporting a Zacks Rank #1 (Strong Buy) at present.
In the past 60 days, estimates for Illumina&#39;s 2024 earnings per share have moved up from $1.84 to $3.63. Earnings per share estimates for 2025 have improved from $3.22 to $4.43. Year to date, shares of ILMN have lost 3.5%.
ILMN&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech&#39;s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 48.7%.
KRYS&#39; earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics&#39; 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.9%.
FULC&#39;s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
<a href="https://www.zacks.com/stock/news/2339326/vnda-stock-down-as-fda-rejects-nda-for-tradipitant-in-gastroparesis?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2339326">To read this article on Zacks.com click here.</a>

Penny Stocks

Small Cap

Markets

FULC

ILMN

KRYS

VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis

<a href="https://www.globenewswire.com/Tracker?data=kXC5zwQobnwJ5tuHPOAJ6PRRMWtoTywyxfs_zeap6YEYFsLA5wSyuoSjT52Uy9zuGU9Ty-L3lVzkhL5ffGzpYbCcDhWpxxnFV7goFgHCYRQ=">Evoke Pharma, Inc.</a>&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EVOK#NASDAQ">EVOK</a>), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on Gimoti&#xAE;&nbsp;(metoclopramide) nasal spray, reaffirms its commitment to improving the lives of patients suffering from diabetic gastroparesis in light of the recent decision by the U.S. Food and Drug Administration (FDA) to not approve Vanda Pharmaceuticals new drug application (NDA) for Tradipitant, an oral drug candidate for the treatment of symptoms in gastroparesis. Patients suffering from all forms of gastroparesis need additional agents to help treat this difficult disease, and we believe patients will be disappointed given the FDA's decision. Evoke continues to serve as a trusted partner for healthcare professionals and patients alike with its proven product, Gimoti&#xAE; (metoclopramide), the first and only FDA-approved nasal spray treatment for acute and recurrent diabetic gastroparesis in adults.

EVOK

Evoke Pharma Reaffirms Its Commitment To Improving The Lives Of Patients Suffering From Diabetic Gastroparesis In Light Of The Recent Decision By The U.S. FDA To Not Approve Vanda Pharmaceuticals NDA For Tradipitant, An Oral Drug Candidate For The Treatment Of Symptoms In Gastroparesis

Thursday,&nbsp;the FDA declined to approve Vanda Pharmaceuticals Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>)&nbsp;New Drug Application (NDA) of tradipitant for symptoms in gastroparesis, providing Vanda with a <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/n40935243/fda-declines-to-approve-vandas-marketing-application-for-tradipitant-in-gastroparesis" rel="noreferrer noopener">Complete Response Letter (CRL)</a>.
Gastroparesis (means&nbsp;paralysis of the stomach) is&nbsp;a condition that slows down the stomach&#8217;s ability to empty its contents.
It is associated with severe nausea, vomiting, and difficulty finishing a normal meal.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/equities/24/06/39530573/whats-going-on-with-vanda-pharmaceuticals-shares-today" rel="noreferrer noopener">What&#8217;s Going On With Vanda Pharmaceuticals Shares Today?</a>
The FDA has approved no effective treatment in over 40 years.
Vanda&#8217;s tradipitant application included evidence from two placebo-controlled studies, the results of which were published in peer-reviewed journals.
The&nbsp;CRL was conclusory in nature. It generally 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 course of the disorder.&nbsp;
Furthermore, the FDA&#8217;s action was delayed by more than 185 days and failed to satisfy the Food Drug and Cosmetic Act (FDCA) requirements.
The FDCA requires that the FDA review a new drug application and provide either an approval or an opportunity for a hearing within 180 days of submission. In this case, the FDA failed to do either.
Despite the FDA&#8217;s disappointing action,&nbsp;Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard and has a favorable benefit-risk profile for gastroparesis patients.&nbsp;
While Vanda has repeatedly requested that the FDA convene an expert advisory committee to review the application and advise the Commissioner on its approvability, the FDA has refused to do so.
The company added that several patients currently treated with tradipitant have filed a Citizen Petition urging the FDA to approve tradipitant for gastroparesis.
Vanda will continue to pursue the marketing authorization for tradipitant and support the expanded access program.
Vanda plans to submit a separate NDA for tradipitant to prevent vomiting in motion sickness later this year.
Price Action: VNDA stock is down 7.68% at $4.57 at the last check on Thursday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/09/40937317/signing-day-sports-and-swifty-global-join-forces-in-all-equity-deal-whats-on-the-cards" target="_blank" rel="noreferrer noopener">Signing Day Sports And Swifty Global Join Forces In All-Equity Deal &#8211; What&#8217;s On The Cards?</a></li>
</ul>

Movers

FDA Strikes Off Vanda Pharmaceuticals' Tradipitant For Stomach Paralysis, Asks For Additional Studies

The FDA Declined To Approve Vanda's New Drug Application Of Tradipitant For The Treatment Of Symptoms In Gastroparesis, Providing Vanda With A Complete Response Letter

Cantor Fitzgerald analyst Charles Duncan maintains Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) with a Overweight and raises the price target from $11 to $13.

Cantor Fitzgerald Maintains Overweight on Vanda Pharma, Raises Price Target to $13

Vanda Pharmaceuticals Reinstates Guidance; Sees FY24 Total Revenues $180M-$210M

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 $(0.21) by 61.9 percent. The company reported quarterly sales of $50.474 million which beat the analyst consensus estimate of $47.860 million by 5.46 percent. This is a 9.59 percent increase over sales of $46.056 million the same period last year.

Vanda Pharma Q2 2024 GAAP EPS $(0.08) Beats $(0.21) Estimate, Sales $50.474M Beat $47.860M Estimate

Cantor Fitzgerald analyst Charles Duncan initiates coverage on Vanda Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) with a Overweight rating and announces Price Target of $11.

Cantor Fitzgerald Initiates Coverage On Vanda Pharma with Overweight Rating, Announces Price Target of $11

Legal

TEVA

US District Court For The District Of Delaware Orders Vanda's HETLIOZ Patent Lawsuit Against Teva And Apotex May Proceed

Vanda Pharmaceuticals Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VNDA#NASDAQ">VNDA</a>) shares are trading lower after Future Pak withdrew its<a target="_blank" href="https://www.benzinga.com/movers" rel="noreferrer noopener"> proposal to purchase the company</a>.
&#8220;Consistent with the position indicated in its June 13, 2024 letter to Vanda Pharmaceuticals, Future Pak LLC and its affiliates today announced that it is withdrawing its offer to acquire the company, effective immediately, and will focus on other strategic objectives,&#8221; <a target="_blank" href="https://www.businesswire.com/news/home/20240626659970/en/" rel="noreferrer noopener">according </a>to a statement.
This decision follows Vanda&#8217;s ongoing lack of response and their rejection of Future Pak&#8217;s final proposal.
According to&nbsp;<a target="_blank" href="https://pro.benzinga.com/?gspk=YWRhbWVja2VydDUzMzY&amp;gsxid=zBMR4PKmcgBw" rel="noreferrer noopener">Benzinga Pro</a>, VNDA stock has lost over 9% in the past year. Investors can gain exposure to the stock via&nbsp;Invesco NASDAQ Future Gen 200 ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQS#NASDAQ">QQQS</a>).
In a recent press release, Vanda mentioned that the takeover proposals from Future Pak and&nbsp;Cycle Group substantially undervalued the company.
Vanda&nbsp;highlighted that the unsolicited proposal from Cycle Group for&nbsp;$8.00&nbsp;per share and the revised unsolicited proposal from Future Pak to acquire Vanda for&nbsp;$8.50-$9.00&nbsp;per share are not in the best interests of the company and its shareholders. &#8220;Accordingly, the Board has rejected the proposals,&#8221; the company said then.
Earlier in April, Vanda rejected Future Pak&#8217;s $7.25 – $7.75 per share offer, saying it significantly&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38297329/neuropsychiatric-focused-vanda-pharmaceuticals-rejects-future-paks-takeover-bid-valued-up-to-7-75" rel="noreferrer noopener">undervalued the company</a>.
In April, the FDA approved&nbsp;Vanda Pharmaceuticals&#8217; Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38068029/why-is-vanda-pharmaceuticals-stock-trading-higher-today" rel="noreferrer noopener">bipolar I disorder in adults</a>.&nbsp;
Price Action: VNDA shares are trading lower by 1.92% to $5.865 at last check Thursday.
Read Next: <a href="https://www.benzinga.com/news/24/06/39516906/elon-musks-spacex-set-for-record-210b-valuation-in-tender-offer-but-still-valued-less-than-tiktok-re" target="_blank" rel="noreferrer noopener">Elon Musk's SpaceX Set For Record $210B Valuation In Tender Offer, But Still Valued Less Than TikTok: Report</a>
Photo via Shutterstock

Equities

QQQS

What's Going On With Vanda Pharmaceuticals Shares Today?

Vanda Pharmaceuticals Inc. (VNDA) Q3 2024 Earnings Call Transcript

Vanda Pharmaceuticals ( ($VNDA) ) has released its Q3 earnings. Here is a breakdown of the information Vanda Pharmaceuticals presented to its inves...

Vanda Pharmaceuticals Reports Strong Q3 2024 Growth

There's a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Vanda (VNDA – Research Report) and Vigil Neuroscienc...

Analysts Are Bullish on Top Healthcare Stocks: Vanda (VNDA), Vigil Neuroscience Inc (VIGL)

Vanda Pharmaceuticals (VNDA)' treatment of polycythemia vera was granted FDA orphan designation, according to a post to the agency's website. Publi...

Vanda Pharmaceuticals treatment of polycythemia vera granted orphan status

Vanda Pharmaceuticals (VNDA) announced the U.S. FDA has granted Orphan Drug Designation for VGT-1849A, a selective antisense oligonucleotide-based ...

Vanda Pharmaceuticals: Orphan Drug Designation Granted for VGT-1849A

Vanda Pharmaceuticals: Net-Net Status Presents A Trading Opportunity

Analyst Ram Selvaraju from H.C. Wainwright reiterated a Buy rating on Vanda (VNDA – Research Report) and keeping the price target at $18.00. Ram Se...

Vanda Pharmaceuticals: Promising Pipeline Developments and Market Potential Drive Buy Rating

Undercovered Dozen: OppFi, PowerFleet, Eletrobras, American Battery +

Vanda Pharmaceuticals (VNDA) issued a letter to FDA Commissioner highlighting what the company considers a faulty gastroparesis NDA review. Vanda h...

Vanda Pharmaceuticals issues letter to FDA on faulty gastroparesis NDA review

Vanda asserts FDA review of tradipitant was flawed

ABAT

AIOT

ARTNA

ARTNB

NGENF

OPFI

PRTA

QMCO

RDWR

RHHBF

RHHBY

RHHVF

TCKRF

TECK

VEOEF

VEOEY

VIGL

Press Releases

Vanda Pharmaceuticals Confirms Receipt of Economically Identical Unsolicited, Non-Binding Proposal from Cycle Group Holdings Ltd.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Vanda Pharmaceuticals Inc. - VNDA

Vanda Pharmaceuticals to Announce Third Quarter 2024 Financial Results on November 6, 2024

Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results

Vanda Pharmaceuticals Announces Participation at November 2024 Investor Conferences

Glancy Prongay & Murray LLP Announces Investigation of Vanda Pharmaceuticals Inc.

Vanda Pharmaceuticals Announces Orphan Drug Designation Granted for VGT-1849A, a Novel and Selective Antisense Oligonucleotide Candidate for the Treatment of Polycythemia Vera

Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review

Abeona Therapeutics

Aldeyra Therapeutics, Inc. - Common Stock

Aldeyra Therapeutics

Amarin Corporation plc - American Depositary Shares, each representing one Ordinary Share

Comments

Vanda Pharma

Actualités

Dernières nouvelles pour Vanda Pharma (NASDAQ:VNDA) Stock

Les gens regardent aussi

Notizie

PARTENAIRE / CONTRIBUTEUR

BENZINGA MONDIAL