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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)

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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 Successfully Completes Placement and Accelerated Entitlement Offer

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Wednesday, March 13, 2024

Principal, LVAD, MESO, Patient, Heart failure, MSB, FDA, Entitlement, Inflammation

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).

Key Points:

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 the Entitlement Offer, primarily from Mesoblast’s existing major shareholders.
Dr. Eric Rose, the Company’s Chief Medical Officer and a director of Mesoblast, subscribed for additional shares of A$1.5 million, subject to shareholder approval.
Dr. Rose is a world-renowned heart surgeon who performed the world’s first successful heart transplant in children and was for many years Chairman of Columbia University’s Department of Surgery.

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)

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Sunday, March 10, 2024

Heart, Licensure, MPC, Incidence, Regenerative Medicine Advanced Therapy, MSB, Inflammation, IL-6, FDA, U.S. FDA, BLA, MESO, Patient, Type, LVAD, Mortality, Pharmaceutical industry

“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.

Key Points:

“We are very pleased with FDA’s feedback that the presented results from our pivotal study of rexlemestrocel-L in end-stage HFrEF patients with LVADs may support an accelerated approval,” said Mesoblast CEO Dr. Silviu Itescu.
“We intend to request a pre-Biologics License Application (BLA) meeting to discuss data presentation, timing and FDA expectations for an accelerated approval filing.”
Every year in the United States over 100,000 patients progress to end-stage HFrEF.
In contrast, in ischemic patients treated with rexlemestrocel-L, IL-6 levels returned to normal by 2 months and remained low through 12 months.
Mesoblast intends to request a pre-BLA meeting with FDA to discuss data presentation, timing and FDA expectations for an accelerated approval filing in end-stage ischemic HFrEF patients with LVAD implantation.

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

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Wednesday, February 28, 2024

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.

Mesoblast Financial Results and Corporate Update Webcast

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Monday, February 26, 2024

EST, MSB, Webcast, Inflammation, AEDT, MESO

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.

Key Points:

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 Investor page of the Company’s website: www.mesoblast.com

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

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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

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 Files for Orphan Drug and Pediatric Rare Disease Designations for Rexlemestrocel-L as Treatment for Severe Congenital Heart Disease

Retrieved on:

Sunday, November 26, 2023

Unfortunately, achievement of this objective is limited by the inability in most patients for the left ventricle to grow sufficiently to support the circulation to the body.

Key Points:

Unfortunately, achievement of this objective is limited by the inability in most patients for the left ventricle to grow sufficiently to support the circulation to the body.
The FDA has authority to grant orphan drug (OD) designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition, defined as any disease or condition that affects less than 200,000 persons in the United States.
An orphan drug designation (ODD) qualifies sponsors for incentives including tax credits for qualified clinical trials, exemption from user fees, and the potential for seven years of market exclusivity after approval.
A rare pediatric disease designation (RPDD) demonstrates that the disease is serious or life-threatening and the manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents, and that the disease is a rare disease or condition.

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.”