{"id":2043,"date":"2023-11-22T00:50:41","date_gmt":"2023-11-22T00:50:41","guid":{"rendered":"https:\/\/economicherald.net\/?p=2043"},"modified":"2023-11-22T00:50:41","modified_gmt":"2023-11-22T00:50:41","slug":"asx-health-stocks-mesoblast-partners-up-for-pivotal-trial-alterity-in-4-8-million-cap-raise","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=2043","title":{"rendered":"ASX Health Stocks: Mesoblast partners up for pivotal trial, Alterity in $4.8 million cap raise"},"content":{"rendered":"

Alterity Therapeutics gets firm commitments for $4.8 million in capital raise
\nMesoblast partners with the Blood and Marrow Transplant Clinical Trials Network for pivotal trial
\nCenters for Medicare & Medicaid Services (CMS) in US confirm tpayment rate for Proteomics PromarkerD predictive test<\/p>\n

Alterity raises $4.8 million in placement<\/p>\n

Biotech focused on developing disease modifying treatments for neurodegenerative diseases Alterity Therapeutics (ASX:ATH)<\/a> says it has received binding commitments for a $4.8 million capital raise via a two tranche placement to Australian and international institutions and other unrelated sophisticated, professional investors.<\/p>\n

CEO David Stamler says the company is grateful for the support from both current and new investors as it continues to advance its clinical development and research programs.<\/p>\n

\u201cWe are making excellent progress with our two Phase 2 clinical trials in multiple system atrophy with enrolment recently completed in our randomised, double-blind ATH434-201 study,\u201d he said<\/a>.<\/p>\n

ATH expects preliminary data from the open label biomarker trial\u00a0in the first half of next year in the first cohort of patients.<\/p>\n

\u201cWe also remain very active within the medical and scientific communities with recent data presentations at the MDS, AAS and Society for Neuroscience meetings,\u201d\u00a0 Stamler says.<\/p>\n

\u201cIn addition, we plan to present new animal data at the Parkinson\u2019s Study Group meeting next month.\u201d<\/p>\n

\u00a0<\/p>\n

Mesoblast partnership for pivotal trial in adults with SR-aGVHD<\/h2>\n

Mesoblast (ASX:MSB)<\/strong><\/a> has announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), has entered into a deal to develop a pivotal trial of its\u00a0 lead product candidate Ryoncil (remestemcel-L) in\u00a0treatment of adults with steroid-refractory acute graft versus host disease (SR-aGvHD)<\/p>\n

The BMT CTN, includes centres responsible for ~80% of all US allogeneic BMTs and is\u00a0funded by the United States National Institutes of Health (NIH).<\/p>\n

\u201cWe are delighted to be partnering with Mesoblast in this pivotal Phase 3 trial of RYONCIL, a potentially life-saving treatment for adolescents and adults with the most severe form of aGVH,\u201d chair-elect of the BMT CTN steering committee and Professor of Internal Medicine and Pediatrics, Icahn School of Medicine at Mount Sinai, New York Dr John Levine, says.<\/p>\n

\u201cThe clinical data from children treated with RYONCIL which support this trial are very compelling.\u201d<\/p>\n

The trial to be developed and executed by the BMT CTN intends to evaluate RYONCIL in patients 12 and older who are refractory to both corticosteroids and a second line agent such as ruxolitinib, for whom there are no approved therapies.<\/p>\n

In its September 2023 draft guidance to industry for development of agents to treat aGVHD, the US FDA said a marketing application might be supported by positive results from a single-arm trial in a population with refractory aGVHD where there are no available therapies.
\n\u00a0<\/p>\n

Reimbursement price set for Proteomics PromarkerD test in US<\/h2>\n

Proteomics International Laboratories (ASX:PIQ)<\/strong><\/a>\u00a0 has announced the Centers for Medicare & Medicaid Services (CMS) have confirmed the payment rate for the PromarkerD predictive test for diabetic kidney disease of US$390.75 in the US.<\/p>\n

The CMS is the US federal agency responsible for providing health coverage to more than 100 million Americans through Medicare and Medicaid.<\/p>\n

The reimbursement rate set by CMS applies to all patients accessing government-funded healthcare in the country. Medicare covers health care costs for people over the age of 65, while Medicaid covers eligible low-income Americans.<\/p>\n

PIQ says the rate, set by the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests, follows a period of public comment and will become effective from January 1, 2024.<\/p>\n

\u201cAs we prepare for the US launch of PromarkerD, the CMS price is an essential component of the roll-out strategy, both because of the number of people it covers, and because many private payers follow CMS pricing,\u201d PIQ managing director Dr Richard Lipscombe says.<\/p>\n

The reimbursement price comes after the American Medical Association (AMA) approved a unique CPT Proprietary Laboratory Analyses (PLA) code 0385U for PromarkerD in January.<\/p>\n

PIQ says ~32 million adults live with diabetes in the US whilst globally this number totals 537 million adults.<\/p>\n

\u00a0<\/p>\n

<\/span><\/p>\n

The post ASX Health Stocks: Mesoblast partners up for pivotal trial, Alterity in $4.8 million cap raise<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

Alterity Therapeutics gets firm commitments for $4.8 million in capital raise Mesoblast partners with the Blood and Marrow Transplant Clinical Trials Network for pivotal trial [more…]<\/a><\/p>\n","protected":false},"author":0,"featured_media":2044,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-2043","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"\nASX Health Stocks: Mesoblast partners up for pivotal trial, Alterity in $4.8 million cap raise - Economic Herald<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/economicherald.net\/?p=2043\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ASX Health Stocks: Mesoblast partners up for pivotal trial, Alterity in $4.8 million cap raise - 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