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 develops allogeneic cellular medicines for severe inflammatory conditions through a proprietary mesenchymal lineage cell therapy platform. Its commercial and pipeline updates center on Ryoncil® (remestemcel-L-rknd), an FDA-approved mesenchymal stromal cell therapy for pediatric steroid-refractory acute graft-versus-host disease, and on additional cell therapy programs for chronic low back pain, heart failure, Duchenne muscular dystrophy and inflammatory or autoimmune diseases.
Recurring company news covers Ryoncil launch and revenue trends, clinical and regulatory developments involving rexlemestrocel-L and Ryoncil label-extension programs, FDA clearances and designations, R&D presentations, technology licensing and platform expansion such as CAR-engineered MSC products, and quarterly cash-flow reporting filed with the Australian Securities Exchange.
Mesoblast (NASDAQ:MESO) has announced the pricing and upcoming availability of its FDA-approved product Ryoncil® for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients. The wholesale acquisition cost is set at US$194,000 per infusion.
The company reported that Ryoncil® demonstrated a 70% overall response rate in Phase 3 trials, with 49% survival through 4 years. The treatment's total benefits range from US$3.2-4.1 million per patient. Mesoblast has established MyMesoblast™ hub for patient services and partnered with Cencora for distribution.
Financial highlights include a cash balance of US$38 million as of December 31, 2024, with pro-forma cash of approximately US$200 million after completing a US$161 million global private placement. The company reported a net loss of US$47.9 million for H1 FY2025, with net operating cash spend reduced by 22% to US$20.7 million compared to H1 FY2024.
Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has announced a webcast to discuss its operational highlights and financial results for the half year ended December 31, 2024. The event will take place on Wednesday, February 26th at 5:00pm EST (Thursday, February 27th, 9:00am AEDT, 2025).
Mesoblast (Nasdaq:MESO; ASX:MSB) has appointed Dr. Gregory George MD PhD, the company's largest shareholder, to its Board of Directors. Dr. George, founder of SurgCenter Development, the largest privately owned ambulatory surgical center company in the US, brings his experience as a medical scientist and successful entrepreneur to the board.
Dr. George expressed his investment conviction in Mesoblast's technology and leadership, highlighting the potential of mesenchymal stem cells to treat various diseases. He emphasized his experience in implementing innovative treatments for musculoskeletal conditions and achieving success through operational excellence.
The appointment aligns with Mesoblast's transition towards becoming an efficient commercial organization, with Chair Jane Bell noting Dr. George's operational and strategic expertise will support the company's goal of becoming a major global commercial biotechnology company.
Mesoblast (Nasdaq:MESO; ASX:MSB) announced its presence at the 2025 Transplantation & Cellular Therapy Tandem Meetings in Honolulu, where it is highlighting Ryoncil® (remestemcel-L), its recently FDA-approved product. Ryoncil® was approved in December 2024 for treating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in pediatric patients 2 months and older, marking the first mesenchymal stromal cell therapy approved in the U.S.
The company's participation includes an information hub for healthcare provider education, executive presentations of scientific and clinical results, and two investigator-led advisory panel meetings. Additionally, Dr. Joanne Kurtzberg from Duke University Medical Center is presenting research on Ryoncil's use in third-line treatment of SR-aGvHD in adolescents and adults.
Mesoblast (MESO) provided an update on the U.S. commercial launch of Ryoncil®, the first FDA-approved MSC therapy for steroid-refractory acute graft-versus-host disease in pediatric patients. The company recently secured US$160 million in financing, resulting in approximately US$200 million cash on hand to support the launch.
The launch will be led by Chief Commercial Officer Marcelo Santoro and will initially target 15 centers that perform half of all pediatric transplants, followed by 30 additional sites accounting for 80% of pediatric transplants. Commercial inventory and distribution network have been established with Cencora.
The company highlighted market opportunities including SR-aGvHD (>$1 billion potential), heart failure (>$10 billion potential), and chronic low back pain (>$10 billion potential). Key upcoming milestones include Ryoncil® launch this quarter, Revascor® FDA meeting, and completion of Rexlemestrocel-L Phase 3 trial for chronic low back pain.
Mesoblast (MESO) reported key developments for Q2 FY2025 ended December 31, 2024. The company achieved a significant milestone with Ryoncil® becoming the first FDA-approved MSC therapy for steroid-refractory acute GvHD in children. A distribution network has been established with Cencora for efficient product delivery.
The company successfully completed a global private placement raising A$260 million (US$161 million). Net operating cash spend was US$10.1 million, reduced by 18% compared to the previous quarter. Cash on hand was US$38 million, with pro-forma cash after January's raise of approximately US$200 million.
The Phase 3 trial of rexlemestrocel-L for chronic low back pain is actively enrolling patients. Under RMAT designation, Mesoblast plans to discuss accelerated approval filing for end-stage heart failure patients with FDA.
Mesoblast's RYONCIL® (remestemcel-L) has received FDA approval as the first mesenchymal stromal cell (MSC) therapy in the United States. The therapy is specifically approved for children aged 2 months and older with steroid-refractory acute graft versus host disease (SR-aGvHD). Clinical trials demonstrated a 70% overall response rate by Day 28 in patients with SR-aGvHD, where 89% had high severity Grade C or Grade D disease. This breakthrough addresses a significant medical need, as approximately 50% of the 10,000 annual U.S. allogeneic bone marrow transplant patients develop aGvHD, with almost half not responding to first-line steroid treatment.
Mesoblast (Nasdaq:MESO; ASX:MSB), a global leader in allogeneic cellular medicines for inflammatory diseases, has announced its upcoming addition to the Nasdaq Biotechnology Index (NBI). The inclusion will be effective after the U.S. market opens on December 23, 2024, as part of the annual reconstitution of the 2024 Nasdaq index.
The NBI includes Nasdaq-listed companies classified as Biotechnology or Pharmaceuticals according to the Industry Classification Benchmark. Companies must meet specific eligibility requirements, including minimum market capitalization and average daily trading volume criteria. The index operates under a modified capitalization-weighted methodology, with constituent selection occurring annually in December.
Mesoblast (MESO) announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Revascor® (rexlemestrocel-L) for treating children with hypoplastic left heart syndrome (HLHS). This follows earlier Rare Pediatric Disease Designation (RPDD) and Orphan-Drug Designation (ODD) granted by the FDA.
Results from a randomized controlled trial with 19 children showed that Revascor administration significantly improved left ventricular volumes over 12 months compared to controls. This growth of the small left ventricle is important for successful surgical correction, enabling normal two-ventricle circulation and reducing risks of heart failure, liver failure, and death.
The RMAT designation provides benefits including Breakthrough and Fast Track designations, rolling review, and priority review eligibility for the Biologics License Application (BLA).
Mesoblast announced significant results from their Phase 3 DREAM-HF trial, published in the European Journal of Heart Failure. The study showed that a single intramyocardial injection of Revascor (rexlemestrocel-L) improved survival in high-risk patients with ischemic heart failure and inflammation. The therapy reduced cardiovascular death risk by 80% in patients with inflammation and reduced major adverse cardiovascular events (MACE) by 88% in patients with ischemic heart failure and inflammation. The company is pursuing approval pathways for Revascor across various heart failure conditions, including pediatric congenital heart disease and adults with ischemic HFrEF.