{"id":9393,"date":"2024-05-09T02:04:52","date_gmt":"2024-05-09T02:04:52","guid":{"rendered":"https:\/\/economicherald.net\/?p=9393"},"modified":"2024-05-09T02:04:52","modified_gmt":"2024-05-09T02:04:52","slug":"asx-health-stocks-neurens-q1-daybue-sales-disappoint-4dx-gets-another-medicare-reimbursement-in-us","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=9393","title":{"rendered":"ASX Health Stocks: Neuren\u2019s Q1 DAYBUE sales disappoint; 4DX gets another Medicare reimbursement in US"},"content":{"rendered":"<p>Neuren Pharma\u2019s Q1 DAYBUE sales disappoint<br \/>\n4DMedical\u2019s CT LVAS technology gets reimbursement in US<br \/>\nMelodiol\u2019s Canadian subsidiary, Mernova, continues to make strong progress<\/p>\n<p>\u00a0<\/p>\n<h2>Neuren\u2019s Q1 disappoints<\/h2>\n<p><strong><a href=\"https:\/\/stockhead.com.au\/company\/neuren-pharmaceuticals-neu\/\">Neuren Pharma (ASX:NEU)<\/a><\/strong> slumped by over -10% this morning after revealing that its Q1 2024 net sales took a bit of a hit.<\/p>\n<p>Neuren\u2019s Q1 net sales of <strong>DAYBUE (trofinetide)<\/strong> in the US came in at US$75.9 million, below its guidance of US$76 to US$82 million, and far below the Q4 2023 sales of US$87.1 million.<\/p>\n<p>Neuren put the decline down to some seasonal effects, including refills due in January actioned in December prior to the holidays, and reduced Rett clinic days in January.<\/p>\n<p>Plus, Neuren said more patients bailed on treatment during Q1 after a surge of new patients in previous quarters.<\/p>\n<p>But the company says it\u2019s seeing new patients hopping back on board, with numbers climbing each of the last six weeks.<\/p>\n<p>About a quarter of the 5,000 diagnosed Rett syndrome patients in the US have now kicked off therapy.<\/p>\n<p>And the numbers sticking with the DAYBUE treatment were better than expected \u2014 58% are still on board after nine months of treatment, which is 10% higher than what was seen in clinical trials.<\/p>\n<p>In terms of royalty payments, anticipated payments to Neuren for DAYBUE are:<\/p>\n<p>Q1 2024 royalties of $11.6 million<br \/>\nFull-year 2024 royalties of between $61 million and $70 million plus sales milestone revenue of $77 million<\/p>\n<p>Due to all these factors, <strong>Neuren\u2019s full year guidance<\/strong> for net sales in 2024 has been reiterated at between US$370 and US$420 million.<\/p>\n<p>\u00a0<\/p>\n<h2>DAYBUE makes traction outside of US<\/h2>\n<p>DAYBUE (trofinetide) has received approval from the US FDA as a treatment for Rett syndrome in both adult and pediatric patients aged two years and above.<\/p>\n<p>Neuren has exclusively licensed the global rights for the development and commercialisation of trofinetide to US-based <em>Acadia Pharmaceuticals.<\/em><\/p>\n<p>Although DAYBUE is presently only approved in the US, Acadia has been making significant strides in its international expansion efforts.<\/p>\n<p>This includes the acceptance for filing of a New Drug Submission in Canada, with priority review granted, potentially leading to approval by the end of 2024.<\/p>\n<p>Additionally, a pediatric investigation plan (PIP) has been filed with and accepted by the European Medicines Agency, with expectations of submitting a Marketing Authorisation Application in Q1 2025.<\/p>\n<p>Furthermore, a formal meeting with the Japanese regulatory agency (PMDA) to discuss the clinical plan is on the agenda for Q2 2024.<\/p>\n<p>\u00a0<\/p>\n<h2>4DMedical\u2019s CT LVAS receives reimbursement in US<\/h2>\n<p>Respiratory imaging technology company, <strong><a href=\"https:\/\/stockhead.com.au\/company\/4d-medical-4dx\/\">4DMedical (ASX:4DX)<\/a><\/strong>, announced that its <strong>CT LVAS<\/strong> technology has been incorporated into existing <strong>Category III Current Procedural Terminology (CPT)<\/strong> codes.<\/p>\n<p>From today, CT LVAS scans conducted in a US hospital outpatient facility for Medicare beneficiaries may be billed to Centers for Medicare &amp; Medicaid Services (CMS) with a <strong>reimbursement of US$650.50<\/strong>.<\/p>\n<p>CMS reimbursement opens up access to CT LVAS at more than 4,000 Medicare-certified hospitals nationwide in the US, making this technology compatible with existing CT scanners and accessible to Medicare beneficiaries dealing with lung disease.<\/p>\n<p>Notably, the payment level established by CMS serves as a reference point for private health insurers when setting their pricing, often resulting in higher rates.<\/p>\n<p>The company now has reimbursement for both <em>CT LVAS <\/em>and <em>XV LVAS<\/em>, having last year successfully established a new CPT code, identifying the use of XV LVAS at the CMS rate of US$299.<\/p>\n<p>\u00a0<\/p>\n<h2>Melodiol continues to make strong progress<\/h2>\n<p>Meanwhile, <strong><a href=\"https:\/\/stockhead.com.au\/company\/melodiol-global-health-me1\/\">Melodiol Global Health (ASX:ME1)<\/a><\/strong> says its wholly owned Canadian subsidiary, <strong>Mernova<\/strong>, continues to make strong operational progress in Q2.<\/p>\n<p>In the quarter, Mernova received purchase orders for $1.3m. This strong start to the quarter follows unaudited Q1 revenues of $1.75m, and FY23 revenues of $6.9m.<\/p>\n<p>In recent weeks, Mernova has also achieved further new product launches.<\/p>\n<p>\u201cMernova continues to deliver strong revenue figures and we are very proud of the team for their ongoing commitment to high quality cannabis,\u201d said <em>Melodiol\u2019s CEO and managing director, William Lay<\/em>.<\/p>\n<p>\u201cWe look forward to generating further purchase orders as new products and formats become available.\u201d<\/p>\n<p>\u00a0<\/p>\n\n<h2>Share prices today:<\/h2>\n<p>\u00a0<\/p>\n\n<p><span class=\"mce_SELRES_start\">\ufeff<\/span><span class=\"mce_SELRES_start\"><\/span>\u00a0<\/p>\n<p>\u00a0<\/p>\n<p><em>At Stockhead we tell it like it is. While Melodiol Global Health is a Stockhead advertiser, it did not sponsor this article.<\/em><\/p>\n<p><span class=\"et_bloom_bottom_trigger\"><\/span><\/p>\n<p>The post <a href=\"https:\/\/stockhead.com.au\/health\/asx-health-stocks-neurens-q1-daybue-sales-disappoint-4dx-gets-another-medicare-reimbursement-in-us\/\">ASX Health Stocks: Neuren\u2019s Q1 DAYBUE sales disappoint; 4DX gets another Medicare reimbursement in US<\/a> appeared first on <a href=\"https:\/\/stockhead.com.au\/\">Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"<p>Neuren Pharma\u2019s Q1 DAYBUE sales disappoint 4DMedical\u2019s CT LVAS technology gets reimbursement in US Melodiol\u2019s Canadian subsidiary, Mernova, continues to make strong progress \u00a0 Neuren\u2019s <a href=\"https:\/\/economicherald.net\/?p=9393\" class=\"read-more-link\">[more&#8230;]<\/a><\/p>\n","protected":false},"author":0,"featured_media":9394,"comment_status":"","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-9393","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>ASX Health Stocks: Neuren\u2019s Q1 DAYBUE sales disappoint; 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