Mesoblast Limited American Depositary Shares - MESO STOCK NEWS

Mesoblast Limited (NASDAQ:MESO; ASX:MSB) has successfully completed a global private placement, raising approximately US$40 million at A$0.85 per share, primarily from existing major shareholders in the US, UK, and Australia. The funds will support the commercialization of remestemcel-L for treating children with steroid-refractory acute graft versus host disease (SR-aGVHD), pending FDA approval, with a PDUFA goal date set for August 2, 2023. Additionally, proceeds will aid in the ongoing manufacturing of this product and the initiation of a Phase 3 clinical trial for rexlemestrocel-L aimed at chronic low back pain. CEO Dr. Silviu Itescu emphasized the company's commitment to bringing innovative treatments to market and acknowledged the strong support from major shareholders.

Mesoblast Limited (Nasdaq: MESO) announced the FDA's ongoing review of its Biologics License Application (BLA) resubmission for remestemcel-L, targeting pediatric patients with steroid-refractory acute graft-versus-host disease (SR-aGVHD). The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023, and scheduled a Pre-License Inspection of the company’s manufacturing facility in Singapore. If approved, remestemcel-L will be the first allogeneic, off-the-shelf therapy for children under 12 with SR-aGVHD, addressing a significant unmet need. The therapy has shown promising survival data in clinical trials.

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.