Mesoblast Stock Price, News & Analysis

Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has announced a webcast to discuss its operational highlights and financial results for the full year ended June 30, 2024. The event is scheduled for Wednesday, August 28 at 6:30pm EDT (Thursday, August 29 at 8:30am AEST). Investors and interested parties can access the webcast through the provided link, with an archived version to be made available on the company's website afterward. This presentation is expected to offer insights into Mesoblast's performance and future outlook in the field of cellular medicines.

Mesoblast (Nasdaq:MESO; ASX:MSB) provided highlights of its activities for Q4 2024 ended June 30. Key points include:

1. Ryoncil BLA resubmission for SR-aGVHD treatment in children accepted by FDA, with a decision expected by January 7, 2025.

2. Phase 3 trial for rexlemestrocel-L in chronic low back pain has commenced enrollment.

3. FDA supports accelerated approval pathway for Revascor in end-stage heart failure patients with LVADs.

4. Cash balance of US$63.0 million as of June 30, 2024, with an additional US$10.0 million available upon Ryoncil approval.

5. 37% reduction in net operating cash spend for Q4 FY2024 compared to Q4 FY2023.

6. Successful implementation of cost containment plan, including voluntary salary reductions for directors.

Mesoblast (Nasdaq:MESO; ASX:MSB) announced that the FDA has accepted its Biologics License Application (BLA) resubmission for Ryoncil® (remestemcel-L) to treat children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA considers the resubmission a complete response, with a decision expected by January 7, 2025. If approved, Ryoncil would 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.

The resubmission addressed remaining CMC items after the FDA indicated in March 2024 that clinical data from the Phase 3 study MSB-GVHD001 appeared sufficient to support the BLA. A Pre-License Inspection of the manufacturing process in May 2023 did not result in any Form 483 issues.

Mesoblast (Nasdaq:MESO; ASX:MSB) has commenced enrollment for its confirmatory Phase 3 trial of rexlemestrocel-L in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease. The trial, aligned with FDA guidelines, involves 300 patients across multiple U.S. sites. The primary endpoint is pain reduction at 12 months, with secondary measures including improved quality of life, function, and reduced opioid usage.

The FDA has granted rexlemestrocel-L Regenerative Medicine Advanced Therapy (RMAT) designation, providing benefits such as rolling review and priority review eligibility. Dr. Alan Miller, a trial investigator, describes the therapy as potentially groundbreaking for the low back pain population.

Mesoblast (Nasdaq: MESO) has resubmitted its Biologics License Application (BLA) to the FDA for Ryoncil® (remestemcel-L), targeting treatment for children with Steroid-Refractory Acute Graft-Versus-Host Disease (SR-aGVHD).

This follows FDA guidance that recent Phase 3 clinical data supports the application. The BLA addresses Chemistry, Manufacturing, and Control (CMC) issues.

Ryoncil® has been granted Fast Track and Priority Review designations, indicating its potential to significantly improve outcomes for children with this serious condition. Approval is expected between two to six months from resubmission.

Mesoblast (Nasdaq:MESO; ASX:MSB) announced that it will file a Biologics License Application (BLA) for its product, Ryoncil® (remestemcel-L), next week. The application seeks FDA approval to use Ryoncil® for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). If approved, this could position Mesoblast as a key player in treating pediatric inflammatory diseases, opening potential new revenue streams and solidifying its leadership in allogeneic cellular medicines.

Mesoblast (Nasdaq:MESO; ASX:MSB) presented a corporate update at the Bell Potter Emerging Leaders Conference. CEO Silviu Itescu announced that the company plans to resubmit its Biologics License Application (BLA) for Ryoncil® (remestemcel-L) for treating steroid-refractory acute graft versus host disease to the FDA this quarter, with potential approval expected in the second half of 2024. The company is also advancing Phase 3 trials for heart failure and back pain treatments, with accelerated approval pathways from the FDA for the heart failure product Revascor® (rexlemestrocel). Mesoblast has a strong intellectual property position in the U.S., with patents covering mesenchymal stem cell compositions that could extend up to 2043, providing a significant commercial advantage.

Mesoblast provided an activity report for the third quarter ended March 31, 2024, highlighting FDA clarity on licensure for remestemcel-L and rexlemestrocel-L. The FDA supports an accelerated approval pathway for rexlemestrocel-L in end-stage heart failure and remestemcel-L in pediatric graft versus host disease. Financially, Mesoblast strengthened its balance sheet, reduced debt, and implemented cost containment strategies.