{"id":656506,"date":"2026-03-15T03:16:30","date_gmt":"2026-03-15T03:16:30","guid":{"rendered":"https:\/\/www.europesays.com\/us\/656506\/"},"modified":"2026-03-15T03:16:30","modified_gmt":"2026-03-15T03:16:30","slug":"vanda-pharmaceuticals-vnda-is-up-13-3-after-rare-fda-hearing-granted-on-hetlioz-jet-lag-bid","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/656506\/","title":{"rendered":"Vanda Pharmaceuticals (VNDA) Is Up 13.3% After Rare FDA Hearing Granted on HETLIOZ Jet Lag Bid"},"content":{"rendered":"<ul>\n<li>Vanda Pharmaceuticals recently received a decision from the U.S. FDA granting a rare formal evidentiary public hearing to review the agency\u2019s proposed refusal to approve a supplemental new drug application for HETLIOZ (tasimelteon) as a treatment for jet lag disorder.<\/li>\n<li>This hearing, which follows Vanda\u2019s earlier legal win requiring the FDA to more fully address its clinical evidence, highlights unusually high regulatory and scientific scrutiny around expanding HETLIOZ into a large, currently untreated travel-related indication.<\/li>\n<li>We\u2019ll now examine how the FDA\u2019s rare public hearing on HETLIOZ for jet lag could reshape Vanda\u2019s risk profile and growth narrative.<\/li>\n<\/ul>\n<p>Invest in the nuclear renaissance through our list of <a href=\"https:\/\/simplywall.st\/discover\/investing-ideas\/473644\/nuclear-renaissance\/global\" target=\"_blank\" rel=\"noopener noreferrer nofollow\" data-vars-link-type=\"intro\" class=\"company-report-links\">86 elite nuclear energy infrastructure plays<\/a> powering the global AI revolution.<\/p>\n<p>Vanda Pharmaceuticals Investment Narrative Recap<\/p>\n<p>To own Vanda today, you need to believe its expanding CNS and rare-disease portfolio can offset HETLIOZ generic pressure and ongoing losses, while management manages cash burn. The FDA\u2019s rare public hearing on HETLIOZ for jet lag raises regulatory uncertainty around a potentially large indication and becomes a key near term catalyst, but also amplifies the risk that added legal and regulatory complexity could weigh on timing and costs if the outcome is unfavorable.<\/p>\n<p>Against this backdrop, the recent FDA approval of BYSANTI for bipolar I and schizophrenia looks especially important, because it strengthens Vanda\u2019s psychiatry franchise at a time when HETLIOZ faces heightened regulatory and competitive headwinds. While BYSANTI will take time to launch and build prescriptions, its approval provides another potential revenue pillar that could reduce dependence on HETLIOZ outcomes and help support the broader growth and pipeline story.<\/p>\n<p>Yet in contrast, you should also be aware that if HETLIOZ\u2019s hearing outcome disappoints and BYSANTI underperforms, Vanda\u2019s reliance on a concentrated portfolio could&#8230;<\/p>\n<p><a href=\"https:\/\/simplywall.st\/community\/narratives\/us\/pharmaceuticals-biotech\/nasdaq-vnda\/vanda-pharmaceuticals\/rlfsvhmg-expanding-global-cns-and-orphan-therapies-will-unlock-future-potential-q8ct\" target=\"_blank\" rel=\"noopener noreferrer nofollow\" data-vars-link-type=\"integrated-pitch\" class=\"company-report-links\">Read the full narrative on Vanda Pharmaceuticals (it&#8217;s free!)<\/a><\/p>\n<p>Vanda Pharmaceuticals&#8217; narrative projects $432.2 million revenue and $7.7 million earnings by 2028. This requires 28.6% yearly revenue growth and a $74.6 million earnings increase from -$66.9 million today.<\/p>\n<p><a href=\"https:\/\/simplywall.st\/community\/narratives\/us\/pharmaceuticals-biotech\/nasdaq-vnda\/vanda-pharmaceuticals\/rlfsvhmg-expanding-global-cns-and-orphan-therapies-will-unlock-future-potential-q8ct\" target=\"_blank\" rel=\"noopener noreferrer nofollow\" data-vars-link-type=\"integrated-pitch\" class=\"company-report-links\">Uncover how Vanda Pharmaceuticals&#8217; forecasts yield a $12.67 fair value<\/a>, a 36% upside to its current price.<\/p>\n<p>Exploring Other Perspectives<a href=\"https:\/\/simplywall.st\/stocks\/us\/pharmaceuticals-biotech\/nasdaq-vnda\/vanda-pharmaceuticals\" target=\"_blank\" rel=\"noopener noreferrer nofollow\" data-vars-link-type=\"infographic\" class=\"company-report-links\"><img decoding=\"async\" src=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2026\/03\/quote-price.png\" loading=\"lazy\" alt=\"VNDA 1-Year Stock Price Chart\" width=\"746\" height=\"476\" class=\"sc-3204b94-0 iJdSPa\"\/><\/a>VNDA 1-Year Stock Price Chart <\/p>\n<p>Pessimistic analysts were already assuming about US$424.9 million in 2028 revenue and continued losses, so this rare HETLIOZ hearing could either ease those psychiatry concentration worries or reinforce them.<\/p>\n<p><a href=\"https:\/\/simplywall.st\/community\/narratives\/us\/pharmaceuticals-biotech\/nasdaq-vnda\/vanda-pharmaceuticals\" target=\"_blank\" rel=\"noopener noreferrer nofollow\" data-vars-link-type=\"integrated-pitch\" class=\"company-report-links\">Explore 9 other fair value estimates on Vanda Pharmaceuticals<\/a> &#8211; why the stock might be worth over 5x more than the current price!<\/p>\n<p>The Verdict Is Yours<\/p>\n<p>Don&#8217;t just follow the ticker &#8211; dig into the data and build a conviction that&#8217;s truly your own.<\/p>\n<p>Looking For Alternative Opportunities?<\/p>\n<p>Every day counts. These free picks are already gaining attention. See them before the crowd does:<\/p>\n<p> This article by Simply Wall St is general in nature. <strong>We provide commentary based on historical data<br \/>\n    and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice.<\/strong> It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your<br \/>\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.<br \/>\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.<br \/>\n    Simply Wall St has no position in any stocks mentioned.<\/p>\n<p><strong>New: <\/strong>Manage All Your Stock Portfolios in One Place<\/p>\n<p>We&#8217;ve created the <strong>ultimate portfolio companion<\/strong> for stock investors, <strong>and it&#8217;s free.<\/strong><\/p>\n<p>\u2022 Connect an unlimited number of Portfolios and see your total in one currency<br \/>\u2022 Be alerted to new Warning Signs or Risks via email or mobile<br \/>\u2022 Track the Fair Value of your stocks<\/p>\n<p><a href=\"https:\/\/simplywall.st\/features\/portfolio\" target=\"_blank\" class=\"sc-kuACkN kjLJKA !text-[--s-button-primary-color-text] !no-underline\" data-focus=\"dashed\" rel=\"nofollow noopener\">Try a Demo Portfolio for Free<\/a><\/p>\n<p class=\"sc-3204b94-2 cZQCtj\"><strong>Have feedback on this article? Concerned about the content? <a href=\"https:\/\/investor-research.typeform.com\/to\/wvg6MFri#feedback_token=NDQ3NTgwNzowOWMyYjg2YWYzZmZmYWRj&amp;company=NasdaqGM:VNDA&amp;blueprintid=4475807\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Get in touch<\/a> with us directly.<\/strong> Alternatively, email <a href=\"https:\/\/simplywall.st\/stocks\/us\/pharmaceuticals-biotech\/nasdaq-vnda\/vanda-pharmaceuticals\/news\/mailto:editorial-team@simplywallst.com?subject=Re%3A%20Your%20article%20on%20NasdaqGM%3AVNDA%20(news)%20from%2012th%20March%202026\" rel=\"nofollow noopener\" target=\"_blank\">editorial-team@simplywallst.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"Vanda Pharmaceuticals recently received a decision from the U.S. FDA granting a rare formal evidentiary public hearing to&hellip;\n","protected":false},"author":3,"featured_media":74241,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[210,1060,67,132,68],"class_list":{"0":"post-656506","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-health","9":"tag-medication","10":"tag-united-states","11":"tag-unitedstates","12":"tag-us"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/116231024778510170","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/656506","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/comments?post=656506"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/656506\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/74241"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=656506"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=656506"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=656506"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}