{"id":773643,"date":"2026-05-04T23:39:26","date_gmt":"2026-05-04T23:39:26","guid":{"rendered":"https:\/\/www.europesays.com\/us\/773643\/"},"modified":"2026-05-04T23:39:26","modified_gmt":"2026-05-04T23:39:26","slug":"mane-study-302-veradermics-posts-positive-top-line-phase-ii-iii-results-for-oral-minoxidil-pill","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/us\/773643\/","title":{"rendered":"MANE Study 302: Veradermics Posts Positive Top-Line Phase II\/III Results for Oral Minoxidil Pill"},"content":{"rendered":"<p>    <img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/www.europesays.com\/us\/wp-content\/uploads\/2026\/05\/5f99e78fdcd92cf28b1f56c771fbb353.jpeg\" alt=\"\" loading=\"eager\" height=\"640\" width=\"960\" class=\"yf-lglytj  loaded\"\/>        Key Points    <\/p>\n<ul class=\"yf-1p2hw41\">\n<li class=\"yf-1p2hw41\">\n<p class=\"yf-1fy9kyt\">Veradermics reported positive Part A results for <strong>VDPHL01<\/strong>, meeting both co\u2011primary endpoints with significant hair\u2011count gains of <strong>+30.3<\/strong> non\u2011vellus hairs (QD) and <strong>+33<\/strong> (BID) at six months and strong patient\u2011reported improvement (nearly 50% QD and ~66% BID rated themselves \u201cimproved\u201d or \u201cmuch improved\u201d).<\/p>\n<\/li>\n<li class=\"yf-1p2hw41\">\n<p class=\"yf-1fy9kyt\">Safety was described as <strong>placebo\u2011like<\/strong> with no drug\u2011related serious adverse events or cardiac AESIs and no meaningful changes in heart rate, blood pressure, or ECGs; the only imbalanced events &gt;5% were edema (\u22481% discontinuation) and hypertrichosis (no discontinuations).<\/p>\n<\/li>\n<li class=\"yf-1p2hw41\">\n<p class=\"yf-1fy9kyt\">Commercially, early market research showed high interest (about <strong>73%<\/strong> of HCPs very\/extremely likely to prescribe), and Veradermics plans additional male readouts in H2 and further Phase III\/12\u2011month data in 2026 before finalizing a QD vs BID filing strategy.<\/p>\n<\/li>\n<li class=\"yf-1p2hw41\">\n<p class=\"yf-1fy9kyt\"><a href=\"https:\/\/www.marketbeat.com\/newsletter\/PDFoffer.aspx?offer=top5&amp;RegistrationCode=YahooFinance\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:Interested in MANE? Here are five stocks we like better.;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;Interested in MANE? Here are five stocks we like better.&quot;}\" class=\"link \">Interested in MANE? Here are five stocks we like better.<\/a><\/p>\n<\/li>\n<\/ul>\n<p class=\"yf-1fy9kyt\">Veradermics reported \u201cpositive top line results\u201d from Part A of its Phase II\/III 302 trial evaluating VDPHL01, an oral extended-release minoxidil tablet, in men with mild to moderate pattern hair loss. On a conference call, CEO Dr. Reid Waldman said the randomized, double-blind, placebo-controlled study achieved \u201ca high degree of statistical significance in both co-primary endpoints and all key secondary endpoints in both dose groups,\u201d while also showing a safety profile he characterized as \u201cplacebo-like overall AE rates.\u201d<\/p>\n<p>      Trial design and endpoints    <\/p>\n<p class=\"yf-1fy9kyt\">According to Waldman, Study 302 enrolled 519 male subjects across 44 U.S. sites. The company presented results from Part A, the six-month placebo-controlled period, for once-daily (QD) and twice-daily (BID) dosing versus placebo.<\/p>\n<p class=\"yf-1fy9kyt\">\u2192 <a href=\"https:\/\/www.marketbeat.com\/originals\/roblox-stock-slides-to-new-low-as-safety-changes-weigh-on-outlook\/\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook&quot;}\" class=\"link \">Roblox Stock Slides to New Low as Safety Changes Weigh on Outlook<\/a><\/p>\n<p class=\"yf-1fy9kyt\">The co-primary endpoints were:<\/p>\n<ul class=\"yf-1p2hw41\">\n<li class=\"yf-1p2hw41\">\n<p class=\"yf-1fy9kyt\"><strong>Target Area Hair Count (TAHC)<\/strong>, measuring non-vellus hairs (&gt;30 microns) per square centimeter using standardized photography and digital image analysis with quality assurance review.<\/p>\n<\/li>\n<li class=\"yf-1p2hw41\">\n<p class=\"yf-1fy9kyt\"><strong>A patient-reported outcome (PRO)<\/strong> responder analysis on the Androgenetic Alopecia Impact Rating Scale (AAIRS), measuring the percentage of patients rating themselves \u201cimproved\u201d or \u201cmuch improved\u201d based on standardized photo comparisons.<\/p>\n<\/li>\n<\/ul>\n<p class=\"yf-1fy9kyt\">Waldman highlighted baseline characteristics he said made the population representative, including enrollment up to age 65, with about 60% over age 40, and an ethnically diverse group. He also said the study did not \u201ccherry-pick\u201d for safety, noting that the majority of subjects had a cardiac risk factor\u2014high blood pressure\u2014which he said is relevant because hypertensive individuals can be more sensitive to minoxidil\u2019s hemodynamic effects.<\/p>\n<p>       Efficacy: hair count gains and patient-reported improvement   <\/p>\n<p class=\"yf-1fy9kyt\">\u2192 <a href=\"https:\/\/www.marketbeat.com\/originals\/the-real-spacex-play-5-chip-stocks-powering-the-ipo-before-it-launches\/\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;The Real SpaceX Play&quot;}\" class=\"link \">The Real SpaceX Play: 5 Chip Stocks Powering the IPO Before It Launches<\/a><\/p>\n<p class=\"yf-1fy9kyt\">On the TAHC endpoint, Waldman reported an increase of <strong>30.3<\/strong> non-vellus hairs in the QD arm and <strong>33<\/strong> in the BID arm at month six. He said the QD performance was \u201cone of the big surprises\u201d and described the results as \u201cleading data on this endpoint,\u201d while cautioning that comparisons to other therapies are cross-trial and not head-to-head.<\/p>\n<p class=\"yf-1fy9kyt\">Waldman said Veradermics\u2019 data suggest <strong>a \u201c150%-300% greater benefit\u201d<\/strong> than oral minoxidil 5 mg, topical minoxidil 5% foam, and finasteride 1 mg, adding that the company\u2019s results were reported on an intention-to-treat basis.<\/p>\n<p class=\"yf-1fy9kyt\">\u2192 <a href=\"https:\/\/www.marketbeat.com\/stock-ideas\/2-stocks-to-watch-as-the-quantum-space-gets-more-crowded\/\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:2 Stocks to Watch as the Quantum Space Gets More Crowded;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;2 Stocks to Watch as the Quantum Space Gets More Crowded&quot;}\" class=\"link \">2 Stocks to Watch as the Quantum Space Gets More Crowded<\/a><\/p>\n<p class=\"yf-1fy9kyt\">On AAIRS, Waldman said nearly half of patients in the QD arm and nearly two-thirds in the BID arm rated themselves as improved or much improved at month six. He added that at month six, nearly 90% of BID patients and nearly 80% of QD patients reported improvement in hair coverage. He also pointed to consistency with the Investigator Global Assessment (IGA), arguing that alignment between physician assessment and patient perception could support real-world adoption.<\/p>\n<p>     Safety: placebo-like adverse event rates and no cardiac AESIs   <\/p>\n<p class=\"yf-1fy9kyt\">Waldman said the company observed no drug-related serious adverse events and no adverse events of special interest (AESIs) of cardiac origin, specifying no pericardial effusion, pleural effusion, angina, or heart failure. He also stated there were no clinically meaningful changes in heart rate, blood pressure, or ECGs.<\/p>\n<p class=\"yf-1fy9kyt\">He added that overall adverse event rates and adverse event-related discontinuation rates were \u201cplacebo-like,\u201d and that adverse events were primarily mild to moderate and often self-resolving.<\/p>\n<p class=\"yf-1fy9kyt\">The only events occurring in more than 5% of patients with an imbalance between active and placebo were <strong>edema<\/strong> and <strong>hypertrichosis<\/strong>. Waldman said edema led to a discontinuation rate \u201capproaching 1%,\u201d while hypertrichosis resulted in \u201czero discontinuations.\u201d He also said participants did not report increased hair shedding after treatment initiation\u2014an effect he described as common with topical and immediate-release oral minoxidil.<\/p>\n<p>     Clinical perspective: unmet need and early adoption potential   <\/p>\n<p class=\"yf-1fy9kyt\">Scientific Advisory Board member Dr. Maryanne Makredes Senna, a board-certified dermatologist and Harvard Medical School assistant professor, described hair loss as deeply impactful and said patients often dislike topical treatments. She said finasteride can fall short on satisfaction in her practice and that patients are concerned about hormonal and sexual side effects. Senna also discussed her experience prescribing immediate-release oral minoxidil off-label, saying patients may see initial improvement but then plateau, with side effects emerging when doses are increased.<\/p>\n<p class=\"yf-1fy9kyt\">Regarding VDPHL01, Senna said the trial design was \u201crobust and\u2026 rigorous\u201d and that the hair count \u201cfar surpasses what we\u2019re seeing with other therapies.\u201d She called the safety signal \u201cvery reassuring,\u201d particularly given that many study participants had cardiovascular risk factors. Senna emphasized the PROs, saying that seeing 86% of patients report improvement is \u201cenormous,\u201d and added that results as early as two months address major prescriber priorities of efficacy, safety, and patient satisfaction. She said that, if approved, the therapy would be \u201ca no-brainer as a first-line therapy\u201d and could \u201cvery quickly\u2026 catch on as the first-line treatment.\u201d<\/p>\n<p>     Commercial read-through: market survey and pricing benchmark   <\/p>\n<p class=\"yf-1fy9kyt\">Chief Commercial and Strategy Officer Mark Neumann described pattern hair loss as \u201cthe largest aesthetics market in the world\u201d and said the company conducted a market survey \u201cthis weekend\u201d following receipt of the top-line results. He said the double-blinded quantitative and qualitative research included 153 healthcare providers and 190 male patients, with respondents spanning both currently treated and untreated segments.<\/p>\n<p class=\"yf-1fy9kyt\">Neumann said more than 90% of both HCPs and patients viewed VDPHL01 as positively differentiated versus available options, with about two-thirds rating it as very or extremely positively differentiated. He also reported that <strong>73%<\/strong> of HCPs were very or extremely likely to prescribe VDPHL01 once approved, and that over 70% of patients were highly likely to talk to their doctor about it.<\/p>\n<p class=\"yf-1fy9kyt\">In Q&amp;A, Waldman said it was \u201ctoo early\u201d to decide between QD and BID regimens for filing, citing another ongoing Phase III trial and longer-term follow-up from Study 302 expected later in the year. He also said the data could \u201cchange the conversation\u201d from stabilization as success toward expecting measurable regrowth.<\/p>\n<p class=\"yf-1fy9kyt\">Asked about longer-term outcomes beyond six months, Waldman said the company does not yet have data to guide expectations but noted hair length still takes time to grow even if density improves.<\/p>\n<p class=\"yf-1fy9kyt\">Regarding pricing, Neumann said final decisions would be made closer to launch. He cited Nutrafol as an \u201cin-market benchmark\u201d at about $90 per month, saying it has \u201cclose to 2 million patients\u201d and generates \u201cover $1 billion a year.\u201d He said Veradermics plans additional pricing sensitivity and willingness-to-pay research with physicians and patients.<\/p>\n<p class=\"yf-1fy9kyt\">Veradermics also said a second male readout is anticipated in the second half of the year, alongside ongoing work in a female trial, with Waldman stating that 2026 could be \u201ca transformational year\u201d including top-line results from the final registration-directed male study and 12-month data from Study 302.<\/p>\n<p>     About MANE (NYSE:MANE)   <\/p>\n<p class=\"yf-1fy9kyt\">MANE is a global manufacturer and supplier of flavors, fragrances and ingredients for the food, beverage, personal care, household and fine fragrance markets. Headquartered in France, the company develops and produces aromatic solutions that are used by consumer goods companies, food processors, perfumers and formulators seeking sensory impact, taste modulation and olfactory character for their products.<\/p>\n<p class=\"yf-1fy9kyt\">The company&#8217;s product portfolio includes savory and sweet flavor systems, beverage concentrates, natural extracts, essential oils, fragrance compounds, cosmetic ingredients and specialty functional solutions such as taste enhancers and odor masking agents.<\/p>\n<p class=\"yf-1fy9kyt\">The article &#8220;<a href=\"https:\/\/www.marketbeat.com\/instant-alerts\/mane-study-302-veradermics-posts-positive-top-line-phase-iiiii-results-for-oral-minoxidil-pill-2026-05-03\/?utm_source=yahoofinance&amp;utm_medium=yahoofinance\" rel=\"nofollow noopener\" target=\"_blank\" data-ylk=\"slk:MANE Study 302: Veradermics Posts Positive Top-Line Phase II\/III Results for Oral Minoxidil Pill;elm:context_link;itc:0;sec:content-canvas\" data-yga=\"{&quot;yLinkElement&quot;:&quot;context_link&quot;,&quot;yModuleName&quot;:&quot;content-canvas&quot;,&quot;yLinkText&quot;:&quot;MANE Study 302&quot;}\" class=\"link \">MANE Study 302: Veradermics Posts Positive Top-Line Phase II\/III Results for Oral Minoxidil Pill<\/a>&#8221; was originally published by MarketBeat.<\/p>\n","protected":false},"excerpt":{"rendered":"Key Points Veradermics reported positive Part A results for VDPHL01, meeting both co\u2011primary endpoints with significant hair\u2011count gains&hellip;\n","protected":false},"author":3,"featured_media":773644,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[34],"tags":[16023,210,316997,316995,1060,18301,32173,316994,316993,67,132,68,316996],"class_list":{"0":"post-773643","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-adverse-events","9":"tag-health","10":"tag-hypertrichosis","11":"tag-line-results","12":"tag-medication","13":"tag-patients","14":"tag-placebo","15":"tag-qd","16":"tag-reid-waldman","17":"tag-united-states","18":"tag-unitedstates","19":"tag-us","20":"tag-waldman"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@us\/116518950135400263","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/773643","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=773643"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/posts\/773643\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media\/773644"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/media?parent=773643"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/categories?post=773643"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/us\/wp-json\/wp\/v2\/tags?post=773643"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}