Mesoblast Limited American Depositary Shares - MESO STOCK NEWS

Mesoblast Limited (Nasdaq: MESO) announced the FDA has accepted their resubmission of the Biologics License Application for remestemcel-L, a therapy for children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA set a PDUFA goal date of August 2, 2023. If approved, remestemcel-L will be the first allogeneic 'off-the-shelf' medicine in the US and the first therapy for children under 12 with SR-aGVHD. The resubmission includes new long-term survival data and manufacturing improvements. The FDA has granted fast track and priority review designations for the therapy, highlighting the urgent need for effective treatments for SR-aGVHD.

Mesoblast Limited (Nasdaq:MESO) reported its financial results for Q2 FY2023, highlighting pivotal developments in its product pipeline. The Biologics License Application (BLA) for remestemcel-L, targeting children with steroid-refractory acute graft versus host disease (SR-aGVHD), was resubmitted to the FDA. The company also received Regenerative Medicine Advanced Therapy (RMAT) designation for rexlemestrocel-L for chronic lower back pain. Financially, revenue from royalties was $1.9 million, a slight decline from $2.3 million in Q2 FY2022, while cash usage decreased 9% year-over-year to $16.5 million. Cash reserves stood at $67.6 million at period-end.

Mesoblast Limited (Nasdaq: MESO) announced a significant advance in cardiovascular care with the publication of Phase 3 DREAM-HF trial results in the Journal of the American College of Cardiology. The study demonstrated that a single intra-myocardial injection of rexlemestrocel-L significantly improved left ventricular ejection fraction after 12 months and reduced the risk of cardiovascular death, myocardial infarction, or stroke by 57% in high-risk patients with chronic heart failure over a 30-month follow-up. The findings highlight the potential of this therapy to address unmet needs in heart failure management.

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.