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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) presented clinical outcomes from its randomized trial of remestemcel-L in COVID-19 ARDS patients at a conference on July 15, 2021. The trial enrolled 222 patients, with 217 randomized to receive standard care or standard care plus remestemcel-L. While the primary endpoint of reducing overall mortality was not met, younger patients (<65) showed improved respiratory function and lower mortality rates. A license agreement with Novartis for remestemcel-L’s development is also noted, pending trial result analysis.
Mesoblast Limited (Nasdaq: MESO) has provided an update on its pain management product, rexlemestrocel-L, targeting chronic low back pain (CLBP) due to degenerative disc disease. The company expects to meet with the FDA this quarter to discuss the regulatory pathway following a Phase 3 trial showing durable pain reduction for at least two years. Mesoblast aims to include EU patients in its upcoming U.S. trial, potentially streamlining regulatory processes. A collaboration with Grünenthal could yield up to $112.5 million in milestone payments.
Mesoblast Limited (NASDAQ: MESO) reported operational and financial results for the period ending March 31, 2021. The company is advancing its regulatory discussions for remestemcel-L, targeting children with steroid-refractory aGVHD and adults with COVID-19 ARDS. Key highlights include significant mortality reduction in patients under 65 from COVID-19 ARDS using remestemcel-L with dexamethasone. However, the total revenue fell slightly to $1.9 million compared to $2.0 million the previous year. After a $110 million private placement, cash on hand stands at $158.3 million.
Mesoblast Limited (Nasdaq: MESO) announced it will host a webcast on June 2, 2021, to present operational highlights and financial results for the period ending March 31, 2021. The company specializes in allogeneic cellular medicines for inflammatory diseases, with a robust portfolio of late-stage product candidates and a global intellectual property portfolio extending through 2040. Mesoblast has completed Phase 3 trials for its products targeting advanced chronic heart failure and chronic low back pain, with ongoing developments for inflammatory conditions in children and adults.
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.
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