Welcome to our dedicated page for Mesoblast news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast stock.
Mesoblast Limited (MESO) is a global leader in developing innovative allogeneic cellular medicines for inflammatory diseases and degenerative conditions. This page provides investors and industry stakeholders with timely updates on clinical advancements, regulatory decisions, and strategic developments shaping the company's trajectory in regenerative medicine.
Access consolidated updates on Mesoblast's pipeline progress, including late-stage trial results for chronic heart failure therapies and manufacturing expansions. Track critical milestones like FDA submissions and international partnership announcements alongside earnings reports and peer-reviewed research publications.
Our news collection serves as a definitive resource for understanding Mesoblast's position in cellular therapeutics, featuring verified updates on:
- Regulatory progress for product candidates across global markets
- Clinical trial outcomes in inflammatory and cardiovascular diseases
- Strategic collaborations with pharmaceutical partners and research institutions
- Manufacturing innovations enabling scalable production of off-the-shelf therapies
Bookmark this page for streamlined monitoring of Mesoblast's advancements in mesenchymal lineage cell technologies and their impact on patient care standards.
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.
FAQ
What is the current stock price of Mesoblast (MESO)?
What is the market cap of Mesoblast (MESO)?
