Mesoblast

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)

Retrieved on: 
Tuesday, March 26, 2024
Patient, MESO, Mesoblast, U.S. FDA, MSB, FDA, BLA, Inflammation

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 graft versus host disease (SR-aGVHD).

Key Points: 
  • 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 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 confidence to refile our BLA for remestemcel-L in children with SR-aGVHD,” said Mesoblast CEO Dr. Silviu Itescu.
  • Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues.

Mesoblast Reports Financial Results and Operational Update for Half-Year Ended December 31, 2023

Retrieved on: 
Wednesday, February 28, 2024
DREAM, RPD, Growth, PLI, SIX, BMT, FIRST, Diagnosis, Mortality, Bangladesh Technical Education Board, Blood, HLHS, MSB, Degenerative disc disease, NIH, Marketing, Pain, MACE, BLA, Survival, Heart failure, Hypoplastic left heart syndrome, LVAD, Randomized controlled trial, FINANCIAL, Inflammation, Biopharmaceutical, ODD, Heart, Mesoblast, Regenerative Medicine Advanced Therapy, FDA, Priority review, MESO, Risk, Administration, Death, Patient, PRV, DDD, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • Reduction in net cash usage for operating activities:
    For the three months ended December 31, 2023, net cash usage was US$12.3 million, a 25% reduction versus the comparative quarter in FY2023.
  • For the six months ended December 31, 2023, net cash usage was US$26.6 million, a 14% reduction versus the comparative period in FY2023.
  • Manufacturing reduced by 47% for the six months ended December 31, 2023, from US$12.8 million to US$6.7 million.

United States Food & Drug Administration (FDA) Grants Mesoblast Orphan-Drug Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Retrieved on: 
Thursday, February 15, 2024
Mesoblast, HLHS, MSB, Randomized controlled trial, FDA, Growth, Inflammation, MESO, Risk, Heart failure, ODD, Death, Hypoplastic left heart syndrome, Pharmaceutical industry

This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.

Key Points: 
  • This follows the Rare Pediatric Disease Designation (RPDD) granted by FDA last month.
  • Mesoblast Chief Executive Silviu Itescu said: “We are very pleased to have now been granted both Orphan-Drug Designation and Rare Pediatric Disease Designation by FDA for REVASCOR in the treatment of children with this often-fatal congenital heart condition.
  • The designations were granted on the back of the results from children in a randomized controlled trial indicating that REVASCOR may increase the ability to successfully accomplish life-saving surgery.
  • Without full BiV conversion the right heart chamber is under excessive strain with increased risk of heart failure and death.

Appendix 4C Quarterly Activity Report for Quarter Ended December 31, 2023

Retrieved on: 
Wednesday, January 31, 2024
Congenital heart defect, FDA, Appendix, MSB, Journal, Bangladesh Technical Education Board, PRV, Survival, Randomized controlled trial, Biopharmaceutical, GVHD, Phases of clinical research, BLA, Hypoplastic left heart syndrome, RPD, HLHS, Growth, Patient, Blood, Inflammation, Priority review, Heart, NIH, Pain, Mesoblast, Ageing, BMT, Executive, MESO, Pharmaceutical industry

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.

Key Points: 
  • 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 will provide the Phase 3 trial protocol to FDA ahead of the upcoming meeting this quarter.
  • Mesoblast will meet with FDA this quarter to address potential pathways to approval for REVASCOR under our Regenerative Medicine Advanced Therapies (RMAT) designation.
  • Revenue from royalties on sales of TEMCELL® HS Inj.5 sold in Japan by our licensee for the quarter were US$1.5 million.

United States Food & Drug Administration (FDA) Grants Mesoblast Rare Pediatric Disease Designation for Revascor® (Rexlemestrocel-L) in Children With Congenital Heart Disease

Retrieved on: 
Thursday, January 18, 2024
PRV, Death, Mesoblast, Heart, RPD, Hypoplastic left heart syndrome, Heart failure, Risk, Priority review, Inflammation, MESO, FDA, BLA, HLHS, MSB, Biopharmaceutical, Randomized controlled trial, Growth, Pharmaceutical industry

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-L) a Rare Pediatric Disease (RPD) Designation following submission of results from the randomized controlled trial in children with hypoplastic left heart syndrome (HLHS), a potentially life threatening congenital heart condition.

Key Points: 
  • RPD Designation is granted by the FDA for certain serious or life-threatening diseases which primarily affect children.
  • On FDA approval of a Biologics Licensing Application (BLA) for REVASCOR for the treatment of HLHS, Mesoblast may be eligible to receive a Priority Review Voucher (PRV) that can be redeemed for any subsequent marketing application or may be sold or transferred to a third party.
  • In the HLHS trial conducted in 19 children, a single intramyocardial administration of REVASCOR at the time of staged surgery resulted in the desired outcome of significantly larger increases in left ventricular (LV) end-systolic and end-diastolic volumes over 12 months compared with controls as measured by 3D echocardiography, (p=0.009 & p=0.020 respectively).
  • Without full BiV conversion the right heart chamber is under excessive strain with increased risk of heart failure and death.

Mesoblast Partners With Blood and Marrow Transplant Clinical Trials Network (BMT CTN) on Pivotal Trial in Adults With SR-aGVHD

Retrieved on: 
Tuesday, November 21, 2023
Food, BMT, MESO, -elect, Mesoblast, FDA, Type, Inflammation, Pediatrics, Clinical trial, NHLBI, Blood, MSB, Lung, Bangladesh Technical Education Board, Internal medicine, NIH, Patient, Pharmaceutical industry

The BMT CTN is funded by the United States National Institutes of Health (NIH).

Key Points: 
  • The BMT CTN is funded by the United States National Institutes of Health (NIH).
  • Prior to implementation, the clinical trial protocol will be reviewed by two independent National Heart, Lung, and Blood Institute (NHLBI)-appointed committees.
  • Mesoblast will then submit the final protocol to FDA, as agreed at the Type A meeting with FDA in September.
  • Mesoblast Chief Executive Silviu Itescu said: “We are pleased to be partnering with the premier hematopoietic stem cell transplant network across the United States with the aim of having a product available for adults suffering from aGVHD and who have no other approved therapies.”

Appendix 4C Quarterly Activity Report for Quarter Ended September 30, 2023

Retrieved on: 
Tuesday, October 31, 2023
Type, FDA, BMT, Inflammation, Mesoblast, Blood, Growth, MESO, Appendix, Chief Medical Officer (Australia), Executive, Non-executive director, MSB, Back pain, Transplant, Dietary supplement, Pharmaceutical industry, Bank

NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the first quarter ended September 30, 2023.

Key Points: 
  • NEW YORK, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided an activity report for the first quarter ended September 30, 2023.
  • In this regard, we are working on corporate initiatives to strengthen our balance sheet, including royalty monetization and strategic partnerships to both access existing commercial distribution channels and supplement costs of development.
  • Cash balance at the end of the quarter was US$53.2 million, with net operating cash spend of US$14.2 million.
  • Revenue from royalties on sales of TEMCELL® HS Inj.2 sold in Japan by our licensee for the quarter were US$1.6 million.

Key Outcomes From FDA Type A Meeting and Mesoblast Next Steps to Achieve RYONCIL Approval

Retrieved on: 
Thursday, September 21, 2023
MESO, BM, Partnership, EAP, GVHD, Blood, Code, Marketing, Expanded access, Survival, CFR, Title 21 of the Code of Federal Regulations, Type, Patient, Steroid, Prochymal, MSB, FDA, Transplant, Inflammation, Dietary supplement, Pharmaceutical industry, Mesoblast

FDA clarified that the key remaining issue for pediatric approval is providing further evidence that the potency assay will assure the consistent efficacy of commercial product.

Key Points: 
  • FDA clarified that the key remaining issue for pediatric approval is providing further evidence that the potency assay will assure the consistent efficacy of commercial product.
  • The key outcomes of the meeting and Mesoblast next steps are:
    Mesoblast summarised the large body of existing clinical data with the improved RYONCIL® product version of remestemcel-L, manufactured after 2008 using the current process inspected by FDA, for potential approval in children.
  • Mesoblast presented clinical data indicating that RYONCIL was associated with much higher survival of children with SR-aGVHD in the Expanded Access Protocol (EAP) compared with the earlier Prochymal version manufactured before 2008.
  • Mesoblast expects to receive the formal minutes of the Type A meeting within three weeks.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Mesoblast Limited - MESO

Retrieved on: 
Friday, September 1, 2023
LLP, Marketing, Mesoblast, FDA, Pomerantz, Regulation of tobacco by the U.S. Food and Drug Administration, BLA, News, Food, Private investigator

NEW YORK, Sept. 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mesoblast Limited (“Mesoblast” or the “Company”) (NASDAQ: MESO).

Key Points: 
  • NEW YORK, Sept. 01, 2023 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Mesoblast Limited (“Mesoblast” or the “Company”) (NASDAQ: MESO).
  • Such investors are advised to contact Robert S. Willoughby at [email protected] or 888-476-6529, ext.
  • The investigation concerns whether Mesoblast and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

Mesoblast Reports Financial Results and Operational Update for Fiscal Year Ended June 30, 2023

Retrieved on: 
Thursday, August 31, 2023
MESO, BM, SR, Regenerative Medicine Advanced Therapy, Research and development, Blood, FINANCIAL, STI, Marketing, Clinical trial, International University of Management and Administration, Degenerative disc disease, Research, LVAD, CMO, Mesoblast, EDT, Pain, Administration, Data analysis, Patient, Survival, Heart, Pivotal, Mortality, Ageing, MSB, Transplant, FDA, BLA, US FDA, Inflammation, Rare-earth element, Pharmaceutical industry, Cryptocurrency, Palladium, Vaccine, Renewable energy, Fine chemical, Takeda, LTI – Lingua Tertii Imperii

NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and an operational update for the period ended June 30, 2023, and provided an overview of upcoming milestones.

Key Points: 
  • NEW YORK, Aug. 30, 2023 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today reported financial results and an operational update for the period ended June 30, 2023, and provided an overview of upcoming milestones.
  • Net cash usage for operating activities was US$63.3 million for FY2023, a 37% reduction compared with FY2021 and 4% reduction compared with FY2022.
  • DETAILS OF FINANCIAL RESULTS FOR THE PERIOD ENDED JUNE 30, 2023 (FY2023)
    Research & Development expenses reduced by US$5.6 million (17%), down to US$27.2 million for FY2023 compared to US$32.8 million for FY2022.
  • It can be accessed via: https://webcast.openbriefing.com/msb-fyr-2023/
    The archived webcast will be available on the Investor page of the Company’s website: www.mesoblast.com