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.

07/13/2026, 8:35 PM • GlobeNewswire

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.

07/09/2026, 8:30 PM • GlobeNewswire

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.

06/30/2026, 8:38 PM • GlobeNewswire

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.

06/24/2026, 8:59 PM • GlobeNewswire

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.

05/22/2026, 10:31 AM • Benzinga

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.

04/29/2026, 8:55 PM • GlobeNewswire

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.

04/28/2026, 8:53 PM • GlobeNewswire

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.

04/07/2026, 11:35 PM • GlobeNewswire

Ryoncil® Continues Successful First Year Launch with Net Sales of US$30.3M in March Quarter

Mesoblast Limited announced Q1 2026 net sales of US$30.3 million for Ryoncil (remestemcel-L-rknd), its FDA-approved mesenchymal stromal cell therapy for steroid-refractory acute graft-versus-host disease in children. Strong February and March sales offset January seasonality, with first-year revenue approaching US$100 million since launch. The company will host an inaugural R&D Day on April 8, 2026, to outline growth strategy and late-stage pipeline programs.

04/06/2026, 9:03 PM • GlobeNewswire

A Key "Master" Protein That Declines by Half After Age 40. One Company Found a Way to Restore It.

Avaí Bio announced it has initiated manufacturing of a Master Cell Bank of genetically modified cells that overexpress the α-Klotho protein, a key anti-aging protein that naturally declines by 50% after age 40. The milestone represents a transition from research to production infrastructure for their Klothonova anti-aging platform using Cell-in-a-Box® encapsulation technology. The cell therapy sector is rapidly expanding, with the global market projected to grow from $10.4 billion to over $45 billion by 2035.

03/18/2026, 10:00 AM • Benzinga

Mesoblast to Host R&D Day on April 8, 2026

Mesoblast Limited announced its inaugural R&D Day scheduled for April 8, 2026 in New York City. The event will feature presentations on the company's corporate strategy, commercialization of its flagship product Ryoncil®, and its pipeline opportunities in inflammatory pain and cardiovascular disease. The company will also unveil new technology for cellular medicines innovation.

03/17/2026, 7:19 PM • GlobeNewswire

Dr. Teresa Montagut Appointed as Clinical Development and Medical Affairs Head at Mesoblast

Mesoblast Limited announced the appointment of Teresa Montagut MD, PhD as Head of Clinical Development and Medical Affairs, a newly created position reporting to the Chief Medical Officer. Montagut brings extensive experience from Regeneron, Novartis, Genentech, and Atara Biotherapeutics, and will lead efforts to expand Ryoncil® indications in pediatric and adult inflammatory conditions and advance the company's cell therapy pipeline.

03/11/2026, 7:21 PM • GlobeNewswire

Cell Therapies Moving From Lab to Factory Floor, and the Stocks Behind Them

The global cell therapy market is projected to surpass $8.2 billion in 2026, with CAR T-cell therapy expanding at 18% annually. Several companies are advancing manufacturing milestones and clinical breakthroughs: Avaí Bio initiated Master Cell Bank production for α-Klotho anti-aging therapy; FibroBiologics secured a patent for fibroblast cell therapy for osteoporosis; Fate Therapeutics achieved same-day hospital discharge for off-the-shelf CAR T-cell patients; Mesoblast presented favorable survival data for Ryoncil® in graft-versus-host disease; and Longeveron published Phase 2b results showing stem cell therapy improved physical condition in age-related frailty patients.

03/03/2026, 10:02 AM • Benzinga

Ryoncil® Profits Underpinning Substantial Growth Pipeline

Mesoblast Limited reported H1 FY2026 financial results showing significant improvement with total revenue of US$51.3 million, primarily driven by successful U.S. commercial launch of Ryoncil®. The company generated US$48.7 million in product revenue with gross profit of US$44.2 million. Net loss improved to US$40.2 million from US$47.9 million year-over-year. Mesoblast has onboarded 49 transplant centers toward a target of 64, secured coverage for 280 million U.S. lives, and is advancing pipeline programs including Phase 3 trials for chronic low back pain and heart failure indications. Full-year FY2026 Ryoncil® revenue guidance is US$110-120 million.

02/26/2026, 7:42 PM • GlobeNewswire

High Survival Rates With Ryoncil® in EIND Program Emphasize Importance of Earlier Use in Both Children and Adults With SR-aGvHD

Mesoblast reported that Ryoncil® (remestemcel-L-rknd), the first FDA-approved mesenchymal stromal cell therapy, achieved high survival outcomes in steroid-refractory acute graft-versus-host disease across children and adults in an EIND program. Data showed 15% mortality in third-line patients versus 2% in second-line Phase 3 trial patients, emphasizing the importance of earlier treatment initiation. The company plans to commence a pivotal Phase 3 trial in adults this quarter, potentially supporting label extension to a population three times larger than the pediatric market.

02/11/2026, 6:27 PM • GlobeNewswire