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 (NASDAQ: MESO; ASX: MSB) generates frequent news flow as it advances and commercializes allogeneic cellular medicines for severe inflammatory diseases. Company announcements highlight developments around its mesenchymal lineage cell therapy platform, led by Ryoncil (remestemcel-L-rknd) for pediatric steroid-refractory acute graft versus host disease (SR-aGvHD), as well as pipeline programs using remestemcel-L and rexlemestrocel-L.
News items commonly cover Ryoncil revenue trends, adoption across U.S. transplant centers, and reimbursement milestones such as assignment of a permanent HCPCS J-Code and expansion of coverage by commercial and government payers. Mesoblast also reports on trading updates, including quarterly activity reports that summarize revenue from cell therapy products and cash flow information released to the Australian Securities Exchange.
Investors following MESO news will see updates on clinical and regulatory progress, including pivotal trial plans for Ryoncil in adults with severe SR-aGvHD in collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network, and ongoing Phase 3 work with rexlemestrocel-L in chronic low back pain associated with degenerative disc disease. Company releases also discuss regulatory designations such as RMAT status for rexlemestrocel-L.
Corporate news includes financing arrangements like new credit facilities and convertible note programs, changes in board and executive roles, and participation in healthcare conferences. This news page aggregates Mesoblast’s press releases and related coverage so readers can review product performance, clinical milestones, capital structure updates, and governance developments in one place.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) plans to host a webcast on February 27, 2023, at 4:30 PM EST to discuss operational highlights and financial results for its second quarter ended December 31, 2022. The company specializes in allogeneic cellular medicines for inflammatory diseases, leveraging its proprietary technologies. Mesoblast has a robust global intellectual property portfolio, and is developing product candidates like remestemcel-L and rexlemestrocel-L targeting severe inflammatory conditions and chronic diseases. The archived webcast will be available on the company’s Investor page for further insights.
Mesoblast Limited (Nasdaq: MESO) announced the selection of two studies on remestemcel-L for treating steroid-refractory acute graft versus host disease (SR-aGVHD) at the 2023 Tandem Meetings in Orlando, Florida. These studies, led by Dr. Joanne Kurtzberg, focus on the therapy’s immunomodulatory effects and long-term survival in pediatric patients. With no approved treatments for children under 12, remestemcel-L could become the first off-the-shelf cellular medicine approved in the U.S. for this condition. The recent BLA resubmission to the FDA includes significant clinical data, indicating a potential survival benefit over current therapies.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for rexlemestrocel-L, aimed at treating chronic low back pain (CLBP) linked to disc degeneration. This designation will expedite the development and regulatory review of the treatment, which has shown significant efficacy in a Phase 3 trial involving 404 patients. Key findings include substantial pain reduction over 36 months, especially for patients with shorter CLBP duration. The need for effective, opioid-sparing treatments for CLBP is critical, as this condition affects a significant portion of the US adult population.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) announces the resubmission of its Biologics License Application (BLA) for remestemcel-L to the FDA for treating children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The resubmission includes new long-term survival data, showing 63% survival at 1 year and 51% at 2 years for treated children, which offers a significant improvement over traditional therapies. If approved, remestemcel-L will be the first treatment available for SR-aGVHD in children under 12, addressing a critical unmet need. The FDA has granted Fast Track and Priority Review designations for the application.
Mesoblast Limited (NASDAQ: MESO) reported its operational and financial highlights for the quarter ending December 31, 2022. The revenue from royalties on TEMCELL sales in Japan rose by 36% to US$1.9 million. The company reduced its net cash usage to US$16.5 million, a decrease of 9% year-over-year. Cash on hand was US$67.6 million, with an additional US$40 million available from financing facilities. Mesoblast plans to file the Biologics License Application (BLA) for remestemcel-L for treating children with steroid-refractory graft versus host disease, emphasizing urgent therapeutic needs. Additionally, preparations are underway for a pivotal Phase 3 trial of rexlemestrocel-L for chronic low back pain.
Mesoblast Limited (Nasdaq:MESO) announced on December 22, 2022, that Oaktree Capital Management has provided an additional US$30 million availability under a five-year facility, contingent on meeting milestones by September 30, 2023. The company previously drew US$60 million in November 2021. The facility has a 9.75% interest rate for three years, followed by principal amortization. As part of the agreement, Oaktree will receive warrants for 455,000 ADS at US$3.70 each, representing a 15% premium to the 30-day VWAP of US$3.22. Mesoblast specializes in allogeneic cellular therapies for inflammatory diseases.
Mesoblast Limited (NASDAQ: MESO) announced promising long-term survival data for remestemcel-L from its Phase 3 trial for children with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The study showed a 51% overall survival rate at 2 years, significantly higher than the 25-38% reported in recent studies using standard therapies. These results are key for the company's resubmission of the Biologics License Application (BLA) to the FDA, emphasizing remestemcel-L's potential as a life-saving treatment in a market with no approved therapies for children under 12.
Mesoblast Limited (ASX:MSB; Nasdaq:MESO) announced significant long-term survival outcomes for children with steroid-refractory graft versus host disease (SR-aGVHD) treated with remestemcel-L, reporting a 49% survival rate at four years. These results support the BLA resubmission to the FDA. Financial highlights include cash reserves of US$85.5 million and a 22% year-over-year reduction in net cash usage, totaling US$14.3 million. Revenue from royalties was US$1.4 million for the quarter. The company anticipates a potential US approval for remestemcel-L by mid-2023.
Mesoblast Limited (Nasdaq: MESO) reported its Q4 activity for the quarter ending September 30, 2022. The company achieved a net cash usage of US$14.3 million, a 22% reduction year-on-year. Cash reserves totaled US$85.5 million, bolstered by a US$45 million placement in August. Key updates include the resubmission of a Biologics License Application for remestemcel-L addressing steroid-refractory graft versus host disease and significant advancements in the rexlemestrocel-L program targeting chronic low back pain and heart failure.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) announced the submission of substantial new data to the FDA regarding its drug remestemcel-L, aimed at treating children with steroid-refractory acute graft versus host disease (SR-aGVHD). This follows a Complete Response Letter from the FDA in September 2020. The submission signifies progress in the company’s FDA response and highlights the urgent need for effective treatments for SR-aGVHD, which has no approved options for children under 12. The drug is under Fast Track Designation and Priority Review by the FDA.