Mesoblast Stock Price, News & Analysis

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.