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Fri, 26 Apr 2024 01:27:32 +0000	Three Leading Growth Companies In Australia With Insider Ownership Reaching 27% As the Australian market navigates through fluctuating bond yields and anticipates potential interest rate hikes, investors are closely monitoring various economic indicators and corporate activities. Amid these conditions, companies with high insider ownership can be particularly intriguing, as such ownership might align management's interests more closely with those of shareholders, potentially fostering greater resilience and long-term strategic focus during uncertain times.
Wed, 27 Mar 2024 15:00:00 +0000	Mesoblast (MESO) to File Pediatric GVHD Drug BLA, Stock Up Mesoblast (MESO) gains as the FDA states that the available phase III data for lead candidate, remestemcel-L, is sufficient to support a regulatory filing for pediatric SR-aGVHD indication.
Tue, 26 Mar 2024 18:47:48 +0000	After Almost 4 Years, FDA Says Mesoblast Phase 3 Therapy Data Can Support Resubmission For Serious Complications in Children Following Stem Cell Transplant Monday, the FDA informed Mesoblast Limited (NASDAQ:MESO) that following additional consideration, the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). “We thank the agency for their collaborative approach. The responses and guidance from FDA are clear and provide us with a high level of
Tue, 26 Mar 2024 02:34:00 +0000	United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graf
Wed, 13 Mar 2024 23:30:00 +0000	Mesoblast Successfully Completes Placement and Accelerated Entitlement Offer NEW YORK, March 13, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has received firm commitments to complete its pro-rata accelerated non-renounceable entitlement offer that was launched on 4 December, 2023 (Entitlement Offer). Together the entitlement offer and institutional placement raised gross proceeds of A$97 million, including A$36.7 million committed today on the same terms as
Sun, 10 Mar 2024 23:54:00 +0000	United States Food & Drug Administration (FDA) Supports Accelerated Approval Pathway for Rexlemestrocel-L in End-Stage Heart Failure Patients with a Left Ventricular Assist Device (LVAD) NEW YORK, March 10, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA supports an accelerated approval pathway for rexlemestrocel-L, Mesoblast’s allogeneic mesenchymal precursor cell (MPC) product, in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device (LVAD). FDA provided this feedback in formal minutes to
Sun, 03 Mar 2024 13:25:08 +0000	Mesoblast Limited (NASDAQ:MESO) Q2 2024 Earnings Call Transcript Mesoblast Limited (NASDAQ:MESO) Q2 2024 Earnings Call Transcript February 29, 2024 Mesoblast Limited isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here). Silviu Itescu: Good morning, good afternoon to Mesoblast’s Financial Results and Operational Update for the Half Year ended December 31, […]
Thu, 29 Feb 2024 20:41:07 +0000	Mesoblast First Half 2024 Earnings: EPS Beats Expectations, Revenues Lag Mesoblast ( ASX:MSB ) First Half 2024 Results Key Financial Results Net loss: US$32.5m (loss narrowed by 21% from 1H...
Wed, 28 Feb 2024 22:57:00 +0000	Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023 NEW YORK, Feb. 28, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an operational update and reported financial results for the period ended December 31, 2023. Mesoblast Chief Executive Silviu Itescu said: “We were very busy operationally during the last quarter and continued to have positive engagement with the United States Food and Drug Administration (FDA) across our lead programs. We
Mon, 26 Feb 2024 12:00:00 +0000	Mesoblast Financial Results and Corporate Update Webcast NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, will host a webcast to discuss operational highlights and financial results for the six months ended December 31, 2023. The webcast will begin at 5.00pm EST, Wednesday, February 28; 9.00am AEDT, Thursday, February 29, 2024. It can be accessed via: https://webcast.openbriefing.com/msb-hyr-2024/ The archived webcast will be available on the
Thu, 15 Feb 2024 00:46:00 +0000	United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease NEW YORK, Feb. 14, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-L) an Orphan-Drug Designation (ODD) following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congeni
Wed, 31 Jan 2024 02:13:00 +0000	Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023 NEW YORK, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the second quarter ended December 31, 2023. Mesoblast Chief Executive Silviu Itescu said: “It has been a very busy quarter in which we have made substantial operational progress across our three lead Phase 3 assets. We have generated significant new potency and characterization data for our lead produ
Fri, 19 Jan 2024 16:30:00 +0000	Mesoblast (MESO) Up on Rare Pediatric Disease Tag for Heart Drug Mesoblast's (MESO) Revascor (rexlemestrocel-L) gets FDA's Rare Pediatric Disease designation for treating children with congenital heart disease. Shares rise in after-hours trading.
Thu, 18 Jan 2024 23:36:00 +0000	United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease REVASCOR Increases Size of Left Heart Chamber and Improves Surgical Outcomes in Children with Hypoplastic Left Heart Syndrome: Results Published in Journal of Thoracic and Cardiovascular Surgery Open NEW YORK, Jan. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted its allogeneic cell therapy Revascor® (rexlemestrocel-
Tue, 09 Jan 2024 00:35:09 +0000	Mesoblast (ASX:MSB) investors are sitting on a loss of 88% if they invested three years ago It's not possible to invest over long periods without making some bad investments. But you have a problem if you face...
Fri, 05 Jan 2024 14:35:02 +0000	Mesoblast Limited (MESO) Loses -5.45% in 4 Weeks, Here's Why a Trend Reversal May be Around the Corner Mesoblast Limited (MESO) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.
Thu, 21 Dec 2023 14:38:00 +0000	5 Stocks to Ride the Santa Claus Rally Mesoblast (MESO), Coinbase (COIN), Western Gas (WES), JAKKS Pacific (JAKK), and Brinker International (EAT) have the potential to outperform in the seven-day period.
Sun, 26 Nov 2023 23:56:00 +0000	Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease NEW YORK, Nov. 26, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has filed for orphan drug designation (ODD) and rare pediatric disease designation (RPDD) with the United States Food and Drug Administration (FDA) for its allogeneic cell therapy Revascor® (rexlemestrocel-L) in the treatment of the congenital heart disease hypoplastic left heart syndrome (HLHS). The filings were b
Thu, 23 Nov 2023 14:27:00 +0000	Mesoblast (MESO) Up on Deal With BMT CTN to Develop GVHD Drug Mesoblast (MESO) partners with Blood and Marrow Transplant Clinical Trials Network to develop a pivotal study on its lead candidate, Ryoncil, for acute graft versus host disease. The stock rises 11%.
Tue, 21 Nov 2023 23:32:00 +0000	Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults With SR-aGVHD NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the Blood and Marrow Transplant Clinical Trials Network (BMT CTN), a body including centers responsible for approximately 80% of all US allogeneic BMTs, has entered into an agreement to develop a pivotal trial of Mesoblast’s lead product candidate Ryoncil® (remestemcel-L) in the treatment of adults with steroid-refrac