Mesoblast Board Changes

Mesoblast Limited announced board changes with the retirement of William Burns (after 12 years) and Philip Krause (since 2022). The company plans to recruit new directors with U.S. and global commercial expertise as it transitions to a revenue-generating commercial enterprise following the FDA approval and successful U.S. launch of Ryoncil® for pediatric steroid-refractory acute graft versus host disease.

11/01/2026, 6:46 PM • GlobeNewswire

Activity Report for Quarter Ended September 30, 2026 (Appendix 4C)

Mesoblast Limited reported a 44% increase in net revenues to US$28 million for RYONCIL in Q1 FY2027, with an 86% improvement in net operational cash spend. The company completed patient enrollment in its Phase 3 pivotal trial for rexlemestrocel-L in chronic low back pain and received FDA alignment for a BLA filing for treatment of life-threatening GI bleeding in end-stage heart failure patients with LVADs. The company maintains US$99 million in cash and is expanding RYONCIL's use in adult steroid-refractory acute graft versus host disease.

10/28/2026, 8:19 PM • GlobeNewswire

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.

08/26/2026, 8:32 PM • GlobeNewswire

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.

07/29/2026, 8:57 PM • GlobeNewswire

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