Sunday, April 26, 2020 11:37:15 PM
China 7 patients - https://t.co/ZhY9iYSiTK?amp=1
The stem cell therapy is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory acute graft-vs.-host disease (aGVHD). The company submitted the final module of a rolling BLA in January 2020. The FDA has set a PDUFA date of Sept. 30 for the product branded as Ryoncil. The clinical data submitted with the BLA showed a survival rate of 79% compared to an expected 30% survival rate in the pediatric phase III trial in aGVHD. “Up to now we’ve been focused on GVHD, so we’ll need to ramp up manufacturing,” the CEO said, adding that he is in active partnering discussions. MESO CHRONIC HEART FAILURE Phase 3 trial (DREAM) 566 randomized patients shall report top-line any time now. 1) an interim futility test which tested safety and efficacy of primary endpoints which was successfully passed. 2) the recent comments of the Data Monitoring Controller at the end of the trial, who is the only person who is un-blinded throughout. 3) Mesoblast having already achieved a major reduction in ischemic cardiac bleeding events in the independently sponsored LVAD trials. 4) the placebo adjusted Results of the phase Two MPC 150m dosage in showing significant improvement in systolic performance of the left ventricle CHRONIC LOWER BACK PAIN Phase 3 trial has just ended and awaiting results. In a Phase 2 trial of 100 patients, randomized placebo/controlled, a single injection of MSC's into the disc in patients with severe chronic disabling back pain resulted in substantial improvement in pain and improvement in function for up to two years in a significantly greater proportion of patients than in the placebo group. The degree of improvement in pain and improvement in function was of an order that was very similar to what one would expect if you underwent a surgical procedure to replace the disc and this is with a simple outpatient procedure and injection that takes no more than about 20 minutes. (Mid 2020)
Recent MESO News
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 08/29/2024 11:14:45 AM
- Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2024 • GlobeNewswire Inc. • 08/28/2024 11:27:43 PM
- Mesoblast Financial Results and Corporate Update Webcast • GlobeNewswire Inc. • 08/27/2024 11:25:57 PM
- Appendix 4C Quarterly Activity Report for Quarter Ended June 30, 2024 • GlobeNewswire Inc. • 07/31/2024 01:13:29 AM
- FDA Accepts Mesoblast’s Biologics License Application (BLA) for Ryoncil® in Children With Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD) • GlobeNewswire Inc. • 07/23/2024 11:53:49 AM
- Patient Enrollment Commenced in Pivotal Phase 3 Trial of Rexlemestrocel-L for Chronic Low Back Pain • GlobeNewswire Inc. • 07/22/2024 12:45:12 AM
- 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) • GlobeNewswire Inc. • 07/09/2024 12:37:09 AM
- Mesoblast to File Biologics License Application for Ryoncil® FDA Approval Next Week • GlobeNewswire Inc. • 07/01/2024 05:55:36 AM
- Mesoblast Corporate Presentation at Investor Conference • GlobeNewswire Inc. • 06/03/2024 12:23:37 AM
- Appendix 4c Quarterly Activity Report for Quarter Ended March 31, 2024 • GlobeNewswire Inc. • 04/30/2024 01:05:17 AM
- FDA Commentary Sends Biotech Soaring During Premarket Hours • AllPennyStocks.com • 03/26/2024 01:25:00 PM
- 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) • GlobeNewswire Inc. • 03/26/2024 02:34:20 AM
- Mesoblast Successfully Completes Placement and Accelerated Entitlement Offer • GlobeNewswire Inc. • 03/13/2024 11:30:47 PM
- 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) • GlobeNewswire Inc. • 03/10/2024 11:54:12 PM
- Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023 • GlobeNewswire Inc. • 02/28/2024 10:57:09 PM
- Mesoblast Financial Results and Corporate Update Webcast • GlobeNewswire Inc. • 02/26/2024 12:00:00 PM
- United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease • GlobeNewswire Inc. • 02/15/2024 12:46:40 AM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 02/01/2024 02:34:30 AM
- Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023 • GlobeNewswire Inc. • 01/31/2024 02:13:34 AM
- Mesoblast Gets FDA's Special Pediatric Designation for Revascor Heart Treatment • Dow Jones News • 01/19/2024 12:28:00 AM
- United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease • GlobeNewswire Inc. • 01/18/2024 11:36:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 01/16/2024 11:33:54 AM
- Form F-6 POS - Post-effective amendments for immediately effective filing • Edgar (US Regulatory) • 01/05/2024 02:57:09 AM
- Form F-6 POS - Post-effective amendments for immediately effective filing • Edgar (US Regulatory) • 12/22/2023 10:13:02 PM
- Mesoblast Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease • GlobeNewswire Inc. • 11/26/2023 11:56:21 PM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
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