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Mesoblast Limited (ASX: MSB; NASDAQ: MESO) is a leading biotechnology company specializing in innovative cell-based medicines. Leveraging its proprietary mesenchymal lineage adult stem cells (MLCs) technology, Mesoblast has established a robust portfolio of advanced cellular medicines. These 'off-the-shelf' allogeneic products use cells from a single donor to treat multiple recipients, eliminating the need for cell matching.
In Japan, Mesoblast's licensee has launched an MLC-based product for acute graft versus host disease (aGVHD) in both children and adults. This marks the first fully approved allogeneic cell-based product in Japan. In the United States, Mesoblast is poised to have its first industrially manufactured allogeneic cell-based product approved.
Mesoblast's lead product candidates include MPC-150-IM for chronic heart failure, MPC-06-ID for chronic low back pain due to disc degeneration, and MSC-100-IV for acute graft versus host disease. The company's pipeline also features remestemcel-L for steroid-refractory aGVHD, moderate to severe acute respiratory distress syndrome (ARDS), and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for advanced chronic heart failure and chronic low back pain.
Mesoblast boasts a strong global intellectual property portfolio, ensuring protection until at least 2041 in major markets. The company's proprietary manufacturing processes produce industrial-scale, cryopreserved, off-the-shelf cellular medicines, intended to be readily available worldwide. Two of its products have already been commercialized in Japan and Europe by its licensees.
Headquartered in Australia, with locations in the United States and Singapore, Mesoblast is listed on the Australian Securities Exchange and NASDAQ. For more information, visit the official website at www.mesoblast.com.
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.
Mesoblast (MESO) has filed a Biologics License Application with the FDA for Ryoncil® in treating steroid-refractory acute graft versus host disease, with a decision expected by January 7, 2025. The company secured a strategic financing agreement for up to US$50.0 million in convertible notes upon FDA approval. First quarter FY2025 showed strong financial management with net operating spend of US$10.5 million, down 26% year-over-year. Cash balance stands at US$51.1 million, with additional US$60.0 million available from existing facilities upon Ryoncil approval.
Mesoblast (Nasdaq:MESO; ASX:MSB) has entered into a convertible note subscription agreement with its largest shareholder, Gregory George, for up to US$50 million in convertible notes. This funding option is contingent on FDA approval of Mesoblast's lead product candidate Ryoncil® for treating children with steroid-refractory acute graft versus host disease (SR-aGvHD). The agreement allows Mesoblast to issue notes in US$10 million tranches within 90 days of FDA approval, expected by January 7, 2025.
Key terms include a 5% annual coupon, a conversion price of US$9.06 per ADR, and a 4-year maturity. The company will also issue warrants as commitment fees. This funding will support Mesoblast's commercial launch strategy, including hiring key personnel, engaging with top treatment centers, and implementing a targeted sales approach focusing on the 15 highest-volume centers accounting for ~50% of patients.
Mesoblast (Nasdaq:MESO; ASX:MSB) reported financial results and operational updates for the fiscal year ended June 30, 2024. Key highlights include:
1. FDA accepted the BLA resubmission for RYONCIL® in treating steroid-refractory acute graft versus host disease in children, with a PDUFA date of January 7, 2025.
2. Enrollment commenced for the confirmatory Phase 3 trial of rexlemestrocel-L for chronic low back pain.
3. FDA granted Rare Pediatric Disease Designation for REVASCOR® in children with congenital heart disease.
4. Cash balance at June 30, 2024, was US$63.3 million, with a 23% reduction in net cash usage for operating activities compared to FY2023.
5. Loss after tax for FY2024 was US$88.0 million, a 7% increase from FY2023.
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 full year ended June 30, 2024. The event is scheduled for Wednesday, August 28 at 6:30pm EDT (Thursday, August 29 at 8:30am AEST). Investors and interested parties can access the webcast through the provided link, with an archived version to be made available on the company's website afterward. This presentation is expected to offer insights into Mesoblast's performance and future outlook in the field of cellular medicines.
Mesoblast (Nasdaq:MESO; ASX:MSB) provided highlights of its activities for Q4 2024 ended June 30. Key points include:
1. Ryoncil BLA resubmission for SR-aGVHD treatment in children accepted by FDA, with a decision expected by January 7, 2025.
2. Phase 3 trial for rexlemestrocel-L in chronic low back pain has commenced enrollment.
3. FDA supports accelerated approval pathway for Revascor in end-stage heart failure patients with LVADs.
4. Cash balance of US$63.0 million as of June 30, 2024, with an additional US$10.0 million available upon Ryoncil approval.
5. 37% reduction in net operating cash spend for Q4 FY2024 compared to Q4 FY2023.
6. Successful implementation of cost containment plan, including voluntary salary reductions for directors.
Mesoblast (Nasdaq:MESO; ASX:MSB) announced that the FDA has accepted its Biologics License Application (BLA) resubmission for Ryoncil® (remestemcel-L) to treat children with steroid-refractory acute graft versus host disease (SR-aGVHD). The FDA considers the resubmission a complete response, with a decision expected by January 7, 2025. If approved, Ryoncil would be the first allogeneic 'off-the-shelf' cellular medicine in the US and the first cell therapy for children up to 18 years old with SR-aGVHD.
The resubmission addressed remaining CMC items after the FDA indicated in March 2024 that clinical data from the Phase 3 study MSB-GVHD001 appeared sufficient to support the BLA. A Pre-License Inspection of the manufacturing process in May 2023 did not result in any Form 483 issues.
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