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ME
Mesoblast Limited American Depositary Shares
MESO
Mkt Cap
$1.73B
Volume
603.57K
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ME
MESO
ME
Mesoblast Limited American Depositary Shares
MESO
News
·
Mesoblast Reports Substantial Revenue Growth to US$120M
Mkt Cap
$1.81B
Volume
603.57K
Next Earnings
N/A
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Mesoblast Reports Substantial Revenue Growth to US$120M
Mesoblast Limited reported strong financial results for FY2026 with total revenue of US$120.3 million, driven by successful RYONCIL commercial launch generating US$115.2 million in net revenue. The company completed patient treatment in its Phase 3 trial for chronic low back pain (rexlemestrocel-L), with results expected mid-2027. Net losses were reduced 44% to US$57.5 million. The company is expanding RYONCIL into adult markets and developing next-generation CAR-MSC and oncolytic virus technologies.
GlobeNewswire Inc. · Aug 27, 2026
Mesoblast Reports Ryoncil® Net Revenues of US$36M for the Quarter and US$115M for First Full Year of Product Launch
Mesoblast Limited reported strong first-year commercial performance for Ryoncil® with Q4 net revenues of US$36M and full-year revenues of US$115M following FDA approval. The company is expanding Ryoncil® indications to adults with steroid-refractory acute GvHD and children with Duchenne muscular dystrophy. Additionally, Mesoblast achieved its target of 300 patients treated in the pivotal Phase 3 trial for rexlemestrocel-L in chronic low back pain and received FDA clearance for a registrational trial in adults with SR-aGvHD.
GlobeNewswire Inc. · Jul 30, 2026
Mesoblast Achieves Target of 300 Treated Patients in Pivotal Phase 3 Trial for Chronic Low Back Pain
Mesoblast Limited announced it has enrolled 300 patients in its MSB-DR004 Phase 3 pivotal trial for rexlemestrocel-L, a cellular medicine for chronic low back pain associated with degenerative disc disease. The trial aims to confirm pain reduction benefits seen in earlier trials, with top-line results expected in mid-2027. The company is proceeding with commercial manufacturing in parallel with the trial, targeting potential peak year revenue exceeding US$10 billion.
GlobeNewswire Inc. · Jul 14, 2026
Ryoncil® Delivers Net Revenue of US$36M for the Fourth Quarter Ended 30 June 2026
Mesoblast Limited announced Ryoncil net revenue of US$36 million for Q4 and US$115 million for fiscal year 2026, exceeding initial projections. The FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease is showing strong uptake across major U.S. pediatric centers. The company maintains a strong capital position with a new five-year facility supporting continued revenue growth and pipeline development.
GlobeNewswire Inc. · Jul 10, 2026
Mesoblast Receives BLA Filing Number and Requests Modular Review for Rexlemestrocel-L in Patients with End-Stage Heart Failure and LVADs
Mesoblast Limited announced it received a Biologics License Application (BLA) filing number from the FDA and requested modular review for rexlemestrocel-L, a cellular therapy for preventing life-threatening gastrointestinal bleeding in end-stage heart failure patients with left ventricular assist devices. The therapy has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy (RMAT) designation, enabling rolling and priority reviews. The announcement comes as the FDA released new guidance supporting regulatory flexibility for orphan rare diseases with high mortality.
GlobeNewswire Inc. · Jul 1, 2026
Mesoblast Draws US$50 Million from Five-Year Non-Dilutive Facility
Mesoblast Limited announced a $50 million drawdown from a five-year credit facility provided by shareholder Dr. Gregory George to refinance higher-cost debt and optimize its capital structure. The new facility carries an 8% fixed interest rate with a five-year interest-only period and is secured solely by Temcell royalties, allowing the company to maintain flexibility for strategic partnerships while maintaining adequate funding for commercial operations and its growth pipeline.
GlobeNewswire Inc. · Jun 25, 2026
Regenerative Medicine's Newest Public Company Is Building Tissue, Not Replacing It
Conexeu Sciences Inc. (CNXU) commenced trading on Nasdaq on May 21, 2026, as a regenerative tissue platform company. The company's proprietary CXU™ extracellular matrix platform is designed to scale across multiple markets including wound care, breast reconstruction, and aesthetic medicine without reformulation. The company targets a 510(k) submission in early 2027 and holds issued patents across major markets with no royalty obligations.
Benzinga · May 22, 2026
Mesoblast Reports Ryoncil® Net Revenues of US$30.3m and Improved Net Operating Cash Spend for the Quarter to US$4.1 Million
Mesoblast Limited reported Q3 FY2026 net revenues of US$30.3 million for Ryoncil®, with cumulative revenues approaching US$100 million since launch. The company achieved patient recruitment targets in its pivotal Phase 3 trial for chronic low back pain, reduced net operating cash spend to US$4.1 million, and acquired exclusive CAR technology for enhanced cell therapy products. Cash position stood at US$122 million.
GlobeNewswire Inc. · Apr 30, 2026
Mesoblast Achieves Patient Recruitment Target in Pivotal Phase 3 Trial for Chronic Low Back Pain
Mesoblast Limited announced that its pivotal Phase 3 clinical trial (MSB-DR004) evaluating rexlemestrocel-L for chronic low back pain associated with degenerative disc disease has completed patient recruitment of at least 300 patients. The placebo-controlled study will follow patients for 12 months, with top-line results expected in mid-2027. A positive outcome could support an FDA regulatory filing in Q3 2027. The therapy has received RMAT designation from the FDA, providing priority review eligibility.
GlobeNewswire Inc. · Apr 29, 2026
Mesoblast Receives IND Clearance from FDA to Directly Proceed to Registrational Trial for Approval of Ryoncil® in Duchenne Muscular Dystrophy
Mesoblast Limited announced FDA clearance to proceed directly to a registrational clinical trial for Ryoncil® (remestemcel-L-rknd) in Duchenne muscular dystrophy (DMD). The trial will randomize 76 patients aged 5-9 years to receive either Ryoncil® or placebo over 9 months, with time-to-stand at nine months as the primary endpoint. The company is partnering with Parent Project Muscular Dystrophy to support patient identification and trial awareness.
GlobeNewswire Inc. · Apr 8, 2026
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