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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 Limited (Nasdaq:MESO) announced positive results from a Phase 2 trial published in Respiratory Research showing that its MSC product remestemcel-L significantly improved respiratory outcomes in COPD patients with high C-reactive protein (CRP) levels. Notable results included improvements in lung function metrics and a 55-meter increase in the six-minute walk test for patients receiving remestemcel-L compared to placebo. These findings suggest potential for remestemcel-L in treating severe lung inflammation, including COVID-19 related ARDS.
Mesoblast Limited (NASDAQ:MESO) announced operational and financial highlights for the quarter ending March 31, 2021. Key updates included a successful US$110 million private placement, boosting cash reserves to US$158.3 million. The trial results for remestemcel-L in COVID-19 patients showed a 46% reduction in mortality in those under 65, and 75% reduction when combined with dexamethasone. Positive outcomes were also reported for rexlemestrocel-L in chronic low back pain patients. Mesoblast is pursuing FDA discussions for potential approvals.
Mesoblast Limited (Nasdaq: MESO) announced significant results from a trial of remestemcel-L in COVID-19 patients with ARDS. The therapy reduced mortality by 46% in patients under 65 years old and by 75% when combined with dexamethasone. Additionally, patients experienced increased days off mechanical ventilation and shorter hospital stays. Mesoblast plans to discuss next steps with the FDA. The trial involved 222 patients, with dosing adapting to changing treatment protocols.
Mesoblast Limited (NASDAQ: MESO; ASX: MSB) announced a corporate update webcast scheduled for April 30, 2021, at 9:00 AM AEST. The company is a leader in allogeneic cellular medicines for inflammatory diseases, with significant advancements in product candidates for severe inflammation. They have completed Phase 3 trials of rexlemestrocel-L and have developed remestemcel-L for various inflammatory conditions. Mesoblast continues to expand its global intellectual property and has commercial partners in Japan and Europe.
Mesoblast Limited (Nasdaq: MESO) announced key operational highlights and upcoming milestones on March 30, 2021. The company successfully completed a US$110 million private placement, boosting its cash balance to US$187.5 million. Recent trial results for rexlemestrocel-L in chronic low back pain and chronic heart failure demonstrated significant pain reduction and decreased cardiac events. Mesoblast is engaged in a licensing agreement with Novartis focused on remestemcel-L for acute respiratory distress syndrome. Upcoming FDA meetings aim to discuss approval pathways for several treatments.
Mesoblast Limited (Nasdaq: MESO) announced the appointment of Philip J. Facchina to its Board of Directors. Facchina, with over 35 years of experience in corporate strategy and finance, is currently the Chief Strategy Officer at SurgCenter Development. His expertise in the ambulatory surgical center market and healthcare will support Mesoblast's strategic initiatives. The company recently completed a US$110 million private placement, with SurgCenter's principals as lead investors. Mesoblast focuses on allogeneic cellular medicines for inflammatory diseases and has advanced clinical programs targeting chronic conditions.
Mesoblast Limited (NASDAQ: MESO) successfully completed a US$110 million private placement, settling on March 8, 2021. The capital raised through the issuance of 60 million shares at A$2.30 each will support regulatory initiatives and operational activities concerning product candidates for steroid-refractory acute graft versus host disease, chronic heart failure, and chronic lower back pain. Post-placement, the pro-forma cash-on-hand is estimated at US$187.5 million.
Mesoblast Limited (Nasdaq: MESO) announced a US$110 million private placement with SurgCenter Development, issuing 60 million shares at A$2.30 each. This price represents a 6.5% discount on the closing price from February 25, 2021. Pro-forma cash on hand is estimated at US$187.5 million. The funding aims to enhance operational strength, support regulatory initiatives, and advance the commercial supply of remestemcel-L and rexlemestrocel-L for various diseases, including chronic heart failure and graft versus host disease. Investors will also receive warrants for 15 million additional shares.
Mesoblast Limited (Nasdaq: MESO) has announced a publication in Pediatrics detailing the successful treatment of two children with life-threatening multisystem inflammatory syndrome (MIS-C) linked to COVID-19 using their MSC product candidate remestemcel-L. The treatment led to normalization of cardiac function and a reduction in inflammation markers. This case highlights the potential of remestemcel-L as a novel therapy for MIS-C, which currently lacks approved treatments. Mesoblast continues to advance its investigational drug programs under existing IND applications.
Mesoblast Limited (Nasdaq:MESO) announced positive results from its Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) due to degenerative disc disease. The study, involving 404 patients, showed that a single injection of rexlemestrocel-L significantly reduced pain for up to 24 months, particularly in patients treated earlier in their disease progression. Additionally, it demonstrated substantial opioid-sparing effects, with notable reductions in opioid use among patients. Mesoblast plans to meet with the FDA to discuss potential approval pathways for this therapy.