{"id":4615,"date":"2024-01-19T00:59:27","date_gmt":"2024-01-19T00:59:27","guid":{"rendered":"https:\/\/economicherald.net\/?p=4615"},"modified":"2024-01-19T00:59:27","modified_gmt":"2024-01-19T00:59:27","slug":"asx-health-stocks-mesoblast-rockets-20pc-after-being-granted-rare-pediatric-disease-designation-by-fda","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=4615","title":{"rendered":"ASX Health Stocks: Mesoblast rockets 20pc after being granted Rare Pediatric Disease Designation by FDA"},"content":{"rendered":"

Mesoblast granted Rare Pediatric Disease (RPD) Designation by FDA
\nVisioneering Technologies releases its full 1-year results on children with myopia<\/p>\n

\u00a0<\/p>\n

Mesoblast blasts away 20pc after FDA approval<\/h2>\n

Mesoblast (ASX:MSB)<\/a><\/strong> jumped as high as 25% this morning after announcing that the US FDA<\/strong> has granted its allogeneic cell therapy Revascor (rexlemestrocel-L)<\/strong> a Rare Pediatric Disease (RPD) Designation<\/strong>.<\/p>\n

An RPD Designation is granted by the FDA for certain serious or life-threatening diseases which primarily affect children.<\/p>\n

The decision follows the submission of results from the randomised controlled trial in children with hypoplastic left heart syndrome (HLHS)<\/strong>, a potentially life threatening congenital heart condition.<\/p>\n

Earlier, results from the REVASCOR<\/strong> trial conducted in the US in children with HLHS were published in the December 2023 issue of the peer-reviewed, \u201cThe Journal of Thoracic and Cardiovascular Surgery Open (JTCVS Open).\u201d<\/p>\n

In that trial conducted in 19 children, a single intramyocardial administration of REVASCOR resulted in the desired outcome.<\/p>\n

This included significantly larger increases in left ventricular (LV) end-systolic and end-diastolic volumes over 12 months, compared with controls.<\/p>\n

As noted earlier by Mesoblast:<\/p>\n

\u201cThe fact that 100% of REVASCOR-treated children compared with 57% of controls had large enough LVs to accommodate the full BiV conversion suggests that REVASCOR treatment may help increase the ability to \u2018better grow\u2019 the HLHS LV after LV recruitment surgery.\u201d<\/p>\n

Mesoblast chief executive Silviu Itescu added today:<\/p>\n

\u201cGiven the impressive enlargement of the left chamber we have seen in these children treated with REVASCOR in the randomised controlled trial and the increased ability to successfully accomplish life-saving surgery, we plan to meet with FDA to discuss the potential for this trial to support accelerated approval in this indication.\u201d<\/p>\n

Upon approval of a Biologics Licensing Application (BLA)<\/strong> for REVASCOR, Mesoblast says it may be eligible to receive an FDA Priority Review Voucher (PRV)<\/strong> that can be redeemed for any subsequent marketing application, or may be sold or transferred to a third party.<\/p>\n

\u00a0<\/p>\n

VTI releases one-year study results<\/h2>\n

Visioneering Technologies (ASX:VTI)<\/a><\/strong> announced the full one-year results of its ongoing multi-center, double-masked, randomised controlled trial (RCT).<\/p>\n

The trial assessed the safety and effectiveness of VTI\u2019s NaturalVue Multifocal Contact (NVMC)<\/strong> lenses for myopia progression control in children<\/strong>.<\/p>\n

The one-year data shows that 45% of subjects in the test group had no myopia progression at all, and nearly two-thirds of subjects in the test group, or 64%, experienced no meaningful progression (defined as 0.25D or less per year).<\/p>\n

Further, 71% (or 0.41D reduction) in refractive error progression versus the control group was observed.<\/p>\n

Children wearing NVMC lenses showed an average refractive error change of 61% (0.17mm) average reduction in axial elongation, versus the control group.<\/p>\n

The average axial length change in children wearing NaturalVue Multifocal Contact lenses was 0.11mm.<\/p>\n

VTI says the PROTECT study is ongoing and data will continue to be reviewed, analysed, and shared as available.<\/p>\n

\u00a0<\/p>\n

Share prices today:<\/h2>\n

\u00a0<\/p>\n\n

\ufeff<\/span><\/span>\u00a0
\n<\/span><\/p>\n

The post ASX Health Stocks: Mesoblast rockets 20pc after being granted Rare Pediatric Disease Designation by FDA<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

Mesoblast granted Rare Pediatric Disease (RPD) Designation by FDA Visioneering Technologies releases its full 1-year results on children with myopia \u00a0 Mesoblast blasts away 20pc [more…]<\/a><\/p>\n","protected":false},"author":0,"featured_media":4616,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4],"tags":[],"class_list":["post-4615","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-finance"],"yoast_head":"\nASX Health Stocks: Mesoblast rockets 20pc after being granted Rare Pediatric Disease Designation by FDA - 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=4615\" \/>\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 rockets 20pc after being granted Rare Pediatric Disease Designation by FDA - 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