Mesoblast Stock Price, News & Analysis

Mesoblast Limited (Nasdaq: MESO) will host a corporate update webcast on February 11, 2021, at 9:30 am AEDT. The session aims to provide insights into the company's developments in allogeneic cellular medicines for inflammatory diseases. Mesoblast focuses on severe conditions through its proprietary mesenchymal lineage cell therapy technology. The company has a strong intellectual property portfolio and has completed Phase 3 trials for various products. Archived webcasts will be accessible on their investor page.

Mesoblast Limited (NASDAQ: MESO) reported a significant reduction in cardiac mortality and major vascular events in its Phase 3 trial of rexlemestrocel-L for chronic heart failure. This represents a major advancement for the high-risk NYHA class II patient population. Revenues from royalties on TEMCELL® HS Inj. rose slightly to US$2.1 million. The company ended December 2020 with US$77.5 million in cash and has access to up to US$92.5 million through existing agreements. Mesoblast anticipates meeting the FDA to discuss approval pathways for several candidates, including remestemcel-L.

Mesoblast Limited (NASDAQ: MESO) announced on October 13, 2020, that its Phase 3 trial for remestemcel-L in COVID-19 patients has exceeded 50% enrollment. This trial aims to reduce 30-day mortality in ventilator-dependent patients with acute respiratory distress syndrome (ARDS). Dr. Fred Grossman emphasized the urgent need for effective treatments as ARDS remains a leading cause of COVID-19 mortality. With enrollment expected to conclude by year-end, the trial builds on a pilot study where 75% of patients were discharged after treatment.

Mesoblast (NASDAQ: MESO) announced that the FDA issued a Complete Response Letter for its Biologics License Application for remestemcel-L, a treatment for pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). Although the FDA's advisory committee recognized the treatment's efficacy, the agency requires additional controlled studies for approval. Mesoblast plans to urgently discuss accelerated approval with the FDA. The company is also conducting a Phase 3 trial for remestemcel-L in ventilator-dependent adults with severe COVID-19 related ARDS, with interim results anticipated in November.

Mesoblast Limited (Nasdaq: MESO) announced that the independent Data Safety Monitoring Board (DSMB) has recommended continuing the Phase 3 trial of remestemcel-L for patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. This recommendation follows the first interim analysis, which reviewed primary endpoint data on all-cause mortality. The trial aims to evaluate if remestemcel-L improves survival in ventilated COVID-19 patients, with recruitment expected to complete in Q4 2020.

Mesoblast Limited (NASDAQ: MESO) reported a robust FY2020, marked by a 92% increase in revenues to US$32.2 million. The company’s lead candidate, remestemcel-L (RYONCIL™), received a positive vote from the FDA Advisory Committee for treating steroid-refractory acute graft versus host disease in children, with the approval decision due by September 30, 2020. The company reported a 13% reduction in losses to US$77.9 million and maintained a strong cash position of US$129.3 million.

Future studies on COVID-19 and chronic heart failure are expected to yield significant results.

Mesoblast Limited (Nasdaq:MESO) plans to host a webcast on August 26, 2020, at 6 PM EDT to present its financial and operational highlights for FY2020, ending June 30, 2020. The company focuses on developing allogeneic cellular medicines for inflammatory diseases and has received FDA priority review for RYONCIL™ to treat pediatric acute graft versus host disease, with a potential U.S. launch in 2020. Mesoblast is conducting Phase 3 trials for advanced heart failure and chronic low back pain and has commercial partnerships in Europe and China.

Mesoblast Limited (Nasdaq: MESO) announced that the FDA's Oncologic Drugs Advisory Committee voted in favor of remestemcel-L (RYONCIL™) for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Dr. Fred Grossman emphasized the critical need for approved therapies for this condition. The FDA has accepted the Biologics License Application for RYONCIL with a priority review, expected to conclude by September 30, 2020. If approved, Mesoblast plans to launch RYONCIL in the US within the year. Acute GVHD affects 50% of bone marrow transplant patients, with severe cases having a potential 90% mortality rate.

Mesoblast Limited (NASDAQ:MESO) announced an upcoming meeting of the FDA's Oncologic Drugs Advisory Committee (ODAC) on August 13, 2020, which will evaluate data supporting the Biologics License Application (BLA) for RYONCIL™ (remestemcel-L) aimed at treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Currently, there are no FDA-approved therapies for this condition. The ODAC will review clinical trial results and vote on the efficacy of remestemcel-L, with a final FDA decision expected by September 30, 2020.