FDA Provides Seven Years of Orphan-Drug Exclusive Approval for Ryoncil® |
NEW YORK, May 14, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has received seven years of orphan-drug exclusive approval from U.S. Food and Drug Administration (FDA) for Ryoncil® (remestemcel-L) for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months of age and older. |
globenewswire.com |
2025-05-15 02:57:00 |
Czytaj oryginał (ang.) |
Bullish On Mesoblast: Shifting To Commercial Stage With Ryoncil Approval And Revascor Trials |
MESO's Off-the-shelf MSC/MPC platform treats severe inflammatory diseases without donor–recipient matching. This alleviates the typical need for immunosuppression. The FDA recently approved Ryoncil, which achieved as much as 70% response in pediatric SR-aGVHD patients. And it has adult SR-aGVHD and Crohn's Phase 3 trials underway. MESO's Revascor is also in trials for chronic low back pain and heart failure, and its accelerated BLA could position it as another revenue vertical in the next couple of. |
seekingalpha.com |
2025-05-05 06:44:44 |
Czytaj oryginał (ang.) |
Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2025 |
NEW YORK, April 29, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the third quarter ended March 31, 2025. |
globenewswire.com |
2025-04-30 00:53:00 |
Czytaj oryginał (ang.) |
Mesoblast Appoints Corporate Finance Leader Lyn Cobley To Board |
NEW YORK, April 28, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Lyn Cobley to its Board of Directors. Ms. Cobley has been a global leader in the financial services industry with over 30 years' experience in senior positions at international and domestic banks. Ms. Cobley has served as CEO of Westpac Institutional Bank, Group Treasurer of Commonwealth Bank of Australia, and held senior roles at Barclays Capital and Citibank Limited. |
globenewswire.com |
2025-04-28 23:44:00 |
Czytaj oryginał (ang.) |
Mesoblast Extends Payer Coverage For Ryoncil® to Over 100 Million US Lives |
NEW YORK, April 16, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has continued to expand coverage for Ryoncil® (remestemcel-L), the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication, to 104 million US lives insured by government and commercial payers. |
globenewswire.com |
2025-04-17 01:20:00 |
Czytaj oryginał (ang.) |
Mesoblast Allogeneic Cell Therapy Products Are Designated ‘U.S. Country of Origin' and Not Subject to U.S. Tariffs |
NEW YORK, April 03, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the status of its products in relation to the U.S. Government's announcement on tariffs for imported products. Mesoblast believes that its allogeneic cellular products, including Ryoncil® and Revascor®, will not be subject to the tariffs. |
globenewswire.com |
2025-04-03 22:58:00 |
Czytaj oryginał (ang.) |
Mesoblast Files Request for Type B Meeting with FDA to Discuss Accelerated Approval Pathway for Revascor® in Ischemic Heart Failure |
NEW YORK, April 02, 2025 (GLOBE NEWSWIRE) -- Mesoblast (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on its plans to meet with the United States Food and Drug Administration (FDA) to discuss the accelerated approval pathway for Revascor® (rexlemestrocel-L) in the treatment of patients with ischemic chronic heart failure with reduced ejection fraction (HFrEF) and inflammation. |
globenewswire.com |
2025-04-02 23:15:00 |
Czytaj oryginał (ang.) |
First Three Children to Commence Treatment With Ryoncil® |
United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage United States Centers for Medicare and Medicaid Services (CMS) Mandates Ryoncil® Coverage |
globenewswire.com |
2025-03-30 23:39:00 |
Czytaj oryginał (ang.) |
Ryoncil® is Now Available for Purchase in the United States |
NEW YORK, March 26, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that Ryoncil® (remestemcel-L) the first mesenchymal stromal cell (MSC) therapy approved by U.S. Food and Drug Administration (FDA) for any indication, is now available for purchase in the United States. |
globenewswire.com |
2025-03-26 22:19:00 |
Czytaj oryginał (ang.) |
Ryoncil® Product Information Now Available in All Four Major Drug Pricing Compendia in United States |
NEW YORK, March 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that pricing information for Ryoncil® is now available in all four major drug pricing compendia in the United States. These pricing compendia provide the official source for all information required to order product, including product manufacturing details, National Drug Codes (NDC) for kit purchase, and kit pricing. |
globenewswire.com |
2025-03-13 21:42:00 |
Czytaj oryginał (ang.) |
Mesoblast CEO to Deliver Featured Presentation at ISCT North America Virtual Town Hall |
NEW YORK, March 12, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that Chief Executive Silviu Itescu will deliver the Featured Presentation at the International Cell & Gene Therapy (ISCT) North America Regional Virtual Town Hall at 4.00pm EDT, Wednesday, March 12th; 7.00am AEDT, Thursday, March 13th, 2025. |
globenewswire.com |
2025-03-12 09:30:00 |
Czytaj oryginał (ang.) |
Mesoblast Limited (MESO) Q2 2025 Earnings Call Transcript |
Mesoblast Limited (NASDAQ:MESO ) Q2 2025 Earnings Conference Call February 26, 2025 5:00 PM ET Company Participants Silviu Itescu - Chief Executive Officer & Managing Director Andrew Chaponnel - Interim Chief Financial Officer Marcelo Santoro - Chief Commercial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Michael Okunewitch - Maxim Group Silviu Itescu Good morning, everybody. I'm Silviu Itescu. |
seekingalpha.com |
2025-02-28 13:38:47 |
Czytaj oryginał (ang.) |
Mesoblast Sets Ryoncil® Price Based on Economic Value of Treatment With Planned Product Availability This Quarter |
Financial Results and Operational Update for Half-Year Ended December 31, 2024 Financial Results and Operational Update for Half-Year Ended December 31, 2024 |
globenewswire.com |
2025-02-26 19:30:00 |
Czytaj oryginał (ang.) |
Mesoblast Limited (MESO) Could Find a Support Soon, Here's Why You Should Buy the Stock Now |
Mesoblast Limited (MESO) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term. |
zacks.com |
2025-02-26 13:01:24 |
Czytaj oryginał (ang.) |
Mesoblast Financial Results and Corporate Update Webcast |
NEW YORK, Feb. 25, 2025 (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 half year ended December 31, 2024. |
globenewswire.com |
2025-02-25 20:13:00 |
Czytaj oryginał (ang.) |
Dr. Gregory George MD PhD Joins Mesoblast Board |
NEW YORK, Feb. 23, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has appointed Dr. Gregory George MD PhD, Mesoblast's largest shareholder, to its Board of Directors. |
globenewswire.com |
2025-02-23 20:33:00 |
Czytaj oryginał (ang.) |
Ryoncil® FDA Approval and Market Launch Highlighted at Tandem Transplantation Meetings |
NEW YORK, Feb. 13, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, today announced that its recently approved product Ryoncil® (remestemcel-L) is being highlighted at the 2025 Transplantation & Cellular Therapy Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR), the industry's premier conference taking place this week in Honolulu, HI. |
globenewswire.com |
2025-02-13 20:37:00 |
Czytaj oryginał (ang.) |
Ryoncil® Commercial Launch Update and Product Pipeline |
NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an update on the progress of the U.S. commercial launch of Ryoncil® (remestemcel-L) for steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months and older and key upcoming milestones for its late-stage pipeline. |
globenewswire.com |
2025-01-30 21:11:00 |
Czytaj oryginał (ang.) |
Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2024 |
NEW YORK, Jan. 30, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the second quarter ended December 31, 2024. |
globenewswire.com |
2025-01-30 20:20:00 |
Czytaj oryginał (ang.) |
MESO Stock Surges 80% in a Month After FDA Approval of GVHD Drug |
Mesoblast stock climbs 80% in a month following the FDA's approval of Ryoncil as the only approved therapy for SR-aGVHD in children aged two months and older. |
zacks.com |
2025-01-03 14:00:34 |
Czytaj oryginał (ang.) |
What Awaits These 4 Biotech Stocks That More Than Doubled in 2024 |
Here are four drug and biotech stocks, ARQT, MESO, MNPR and KOD, which have more than doubled in 2024 with room for further growth in 2025. |
zacks.com |
2024-12-26 13:32:08 |
Czytaj oryginał (ang.) |
MESO Stock Up as FDA Approves Ryoncil for Graft Versus Host Disease |
The FDA approves Mesoblast's Ryoncil (remestemcel-L) for treating pediatric patients with steroid-refractory acute graft versus host disease. Shares rise. |
zacks.com |
2024-12-19 16:21:11 |
Czytaj oryginał (ang.) |
Mesoblast's Cell Therapy Treatment For Graft Versus Host Disease Gets FDA Approval, Stock Surges |
On Wednesday, the FDA approved Mesoblast Limited's MESO Ryoncil (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the U.S. |
benzinga.com |
2024-12-19 08:38:08 |
Czytaj oryginał (ang.) |
Mesoblast's RYONCIL® is the First U.S. FDA-Approved Mesenchymal Stromal Cell (MSC) Therapy |
NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced the Food and Drug Administration (FDA) approved Ryoncil® (remestemcel-L) as the first mesenchymal stromal cell (MSC) therapy in the United States. RYONCIL is the only MSC therapy approved in the U.S. for any indication, and the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in children 2 months and older, including adolescents and teenagers. |
globenewswire.com |
2024-12-18 21:08:00 |
Czytaj oryginał (ang.) |
Top-Notch Biotech Mesoblast Skyrockets 29% On Immune Condition Approval |
Mesoblast snagged FDA approval late Wednesday for the first-ever treatment for children with a form of GVHD. The biotech stock rocketed. |
investors.com |
2024-12-18 20:44:25 |
Czytaj oryginał (ang.) |
US FDA approves Mesoblast's cell therapy for graft-versus-host disease |
The U.S. Food and Drug Administration on Wednesday approved Mesoblast's cell therapy for treating a type of complication that occurs after a stem cell or bone marrow transplant called graft-versus-host disease. |
reuters.com |
2024-12-18 18:58:06 |
Czytaj oryginał (ang.) |
Mesoblast to be Added to Nasdaq Biotechnology Index |
NEW YORK, Dec. 18, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced its upcoming addition to the Nasdaq Biotechnology Index (Nasdaq: NBI) as part of the annual reconstitution of the 2024 Nasdaq index. Mesoblast's inclusion in the NBI will be effective after the U.S. market opens on Monday, December 23, 2024. |
globenewswire.com |
2024-12-18 09:30:00 |
Czytaj oryginał (ang.) |
FDA Grants Revascor® (Rexlemestrocel-L) Regenerative Medicine Advanced Therapy (RMAT) Designation in Children with Congenital Heart Disease |
Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease Earlier this year FDA granted REVASCOR both Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) for congenital heart disease |
globenewswire.com |
2024-12-04 20:32:00 |
Czytaj oryginał (ang.) |
Revascor Improves Survival and Reduces Major Morbidity in High-Risk Ischemic Heart Failure Patients With Inflammation |
Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy Phase 3 trial results published in European Journal of Heart Failure identify key target population for Mesoblast allogeneic cell therapy |
globenewswire.com |
2024-12-02 20:20:00 |
Czytaj oryginał (ang.) |
Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2024 |
NEW YORK, Oct. 30, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided highlights of its recent activities for the first quarter ended September 30, 2024. |
globenewswire.com |
2024-10-30 21:11:00 |
Czytaj oryginał (ang.) |
Mesoblast: Undervalued Due To Remestemcel-L's Substantial Growth Potential |
Mesoblast Limited is advancing innovative cellular therapies, with Remestemcel-L for pediatric SR-aGVHD nearing FDA approval and a PDUFA date set for January 2025. Positive Phase 3 results indicate that Remestemcel-L significantly improves response rates and survival in pediatric patients. Additionally, Mesoblast's pipeline includes late-stage therapies for chronic low back pain and heart failure, both of which are showing promising results and are nearing regulatory approval. |
seekingalpha.com |
2024-09-30 20:24:02 |
Czytaj oryginał (ang.) |
Mesoblast Option to Issue Up to US$50 Million Convertible Notes for Product Launch |
NEW YORK, Sept. 29, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced it has entered into a convertible note subscription agreement with its largest shareholder Gregory George (“Investor”) for issue, at its sole discretion, up to US$50.0 million (A$72.7 million) convertible notes on approval by the United States Food and Drug Administration (FDA) of Mesoblast's lead product candidate Ryoncil® (remestemcel-L) in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGvHD). The funding is available at Mesoblast's option and will enable the Company to seamlessly implement its go-to-market commercial strategy. Mesoblast anticipates a decision prior to or on the FDA's Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2025. |
globenewswire.com |
2024-09-30 00:55:00 |
Czytaj oryginał (ang.) |
Mesoblast Limited (MESO) Q4 2024 Earnings Call Transcript |
Mesoblast Limited (NASDAQ:MESO ) Q4 2024 Earnings Conference Call August 28, 2024 6:30 PM ET Company Participants Silviu Itescu - Chief Executive Officer and Managing Director Andrew Chaponnel - Interim Chief Financial Officer Conference Call Participants Edward Tenthoff - Piper Sandler Operator Hello and welcome to the Mesoblast Financial Results for the Full Year ended June 30, 2024. An announcement and presentation have been lodged with the ASX and are available on the home and investor pages at www. |
seekingalpha.com |
2024-08-29 01:04:07 |
Czytaj oryginał (ang.) |
Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024 |
NEW YORK, Aug. 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 June 30, 2024. Mesoblast Chief Executive Silviu Itescu said: “During the past year we have built significant momentum in our interactions with the United States Food and Drug Administration (FDA) across each of our Phase 3 products. |
globenewswire.com |
2024-08-28 23:27:00 |
Czytaj oryginał (ang.) |
Mesoblast Financial Results and Corporate Update Webcast |
NEW YORK, Aug. 27, 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 full year ended June 30, 2024. |
globenewswire.com |
2024-08-27 23:25:00 |
Czytaj oryginał (ang.) |
Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024 |
Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD Ryoncil BLA Submission Under FDA Review for Approval in Children with SR-aGVHD |
globenewswire.com |
2024-07-31 01:13:00 |
Czytaj oryginał (ang.) |
FDA Accepts Mesoblast's Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD If Approved, RYONCIL will be the First Allogeneic “Off-the-Shelf” Cellular Medicine in the US, and the First Cell Therapy for Children Up To 18 Years Old with SR-aGVHD |
globenewswire.com |
2024-07-23 11:53:00 |
Czytaj oryginał (ang.) |
Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain |
NEW YORK, July 21, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the confirmatory Phase 3 trial of its allogeneic, immunoselected, and industrially manufactured stromal cell product rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease of less than five years duration has commenced enrollment at multiple sites across the United States. |
globenewswire.com |
2024-07-22 00:45:00 |
Czytaj oryginał (ang.) |
Mesoblast Resubmits Biologics License Application (BLA) with United States Food & Drug Administration (FDA) for Approval of Ryoncil® in Children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) |
NEW YORK, July 08, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil® (remestemcel-L) in the treatment of children with SR-aGVHD. |
globenewswire.com |
2024-07-09 00:37:00 |
Czytaj oryginał (ang.) |