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

Ryoncil® Net Revenues Increase for the Quarter to US$30M

Mesoblast Limited reported a 60% quarter-over-quarter increase in Ryoncil gross sales to US$35 million for Q2 FY2026. Real-world data showed 84% survival rate in pediatric SR-aGvHD patients completing 28-day treatment. The company secured a new US$125 million non-dilutive credit facility at 8% interest and received positive FDA feedback on rexlemestrocel-L for chronic low back pain, with a Phase 3 confirmatory trial actively recruiting.

01/28/2026, 6:54 PM • GlobeNewswire

Real-World Commercial Experience with Ryoncil® Shows 84% Survival of Children with SR-aGvHD After Completing 28-Days of Treatment

Mesoblast reported that 84% of the first 25 children treated with Ryoncil® (remestemcel-L-rknd) in real-world clinical settings completed the initial 28-day treatment regimen for steroid-refractory acute graft-versus-host disease. The company has onboarded 45 transplant centers with a target of 64, and has secured coverage extending to over 260 million U.S. lives. A pivotal trial in adults with severe SR-aGvHD is expected to commence enrollment this quarter.

01/26/2026, 6:45 PM • GlobeNewswire

FDA Acknowledges Effects on Pain Intensity Favor Rexlemestrocel-L, Confirms 12-Month Reduction in Back Pain Supports Product Efficacy

The FDA provided positive feedback on Mesoblast's rexlemestrocel-L, an allogeneic cell therapy for chronic discogenic low back pain, acknowledging that pain reduction effects favor the active treatment over placebo at 12 months. The FDA confirmed this clinically meaningful reduction can support product efficacy and that opioid reduction results can be included in product labeling. A second Phase 3 trial (MSB-DR004) is over 50% enrolled with completion expected within three months.

01/18/2026, 7:01 PM • GlobeNewswire

Ryoncil® Sales Increase 60% in December Quarter to US$35.1M

Mesoblast Limited reported gross revenue of US$35.1 million for Ryoncil® in Q2 2025, representing a 60% increase from the prior quarter. The company secured a new US$125 million five-year facility with substantially lower costs, enabling repayment of prior senior debt and providing flexibility for strategic partnerships and label expansion efforts.

01/08/2026, 6:46 PM • GlobeNewswire