Welcome to our dedicated page for Mesoblast news (Ticker: MESO), a resource for investors and traders seeking the latest updates and insights on Mesoblast stock.
Mesoblast Limited (NASDAQ: MESO; ASX: MSB) generates frequent news flow as it advances and commercializes allogeneic cellular medicines for severe inflammatory diseases. Company announcements highlight developments around its mesenchymal lineage cell therapy platform, led by Ryoncil (remestemcel-L-rknd) for pediatric steroid-refractory acute graft versus host disease (SR-aGvHD), as well as pipeline programs using remestemcel-L and rexlemestrocel-L.
News items commonly cover Ryoncil revenue trends, adoption across U.S. transplant centers, and reimbursement milestones such as assignment of a permanent HCPCS J-Code and expansion of coverage by commercial and government payers. Mesoblast also reports on trading updates, including quarterly activity reports that summarize revenue from cell therapy products and cash flow information released to the Australian Securities Exchange.
Investors following MESO news will see updates on clinical and regulatory progress, including pivotal trial plans for Ryoncil in adults with severe SR-aGvHD in collaboration with the NIH-funded Blood and Marrow Transplant Clinical Trials Network, and ongoing Phase 3 work with rexlemestrocel-L in chronic low back pain associated with degenerative disc disease. Company releases also discuss regulatory designations such as RMAT status for rexlemestrocel-L.
Corporate news includes financing arrangements like new credit facilities and convertible note programs, changes in board and executive roles, and participation in healthcare conferences. This news page aggregates Mesoblast’s press releases and related coverage so readers can review product performance, clinical milestones, capital structure updates, and governance developments in one place.
Mesoblast Limited (Nasdaq: MESO) reports financial results for FY2022, highlighting a cash position of US$60.4 million and pro-forma cash of US$105.5 million after a US$45 million private placement. Total revenue increased 37% to US$10.2 million, driven by royalties from TEMCELL® HS Inj.1 in Japan. The company anticipates BLA resubmission for remestemcel-L in children with SR-aGVHD this quarter and FDA meetings regarding rexlemestrocel-L for chronic heart failure. Significant cost reductions were achieved, with a 35% decrease in net operating spend, totaling US$65.8 million.
Mesoblast Limited (NASDAQ: MESO) will host a webcast on August 30, 2022, at 6:30 PM EDT to discuss operational highlights and financial results for Q4 and the full year ending June 30, 2022. As a leader in allogeneic cellular medicines for inflammatory diseases, Mesoblast has developed a range of late-stage product candidates targeting severe conditions, leveraging its proprietary cell therapy technology. The company maintains a robust intellectual property portfolio and has initiated commercial partnerships in Europe and China for specific product assets.
Mesoblast Limited (Nasdaq: MESO; ASX: MSB) has appointed Jane Bell as an Independent Non-Executive Director. Bell brings 22 years of corporate finance experience and diverse healthcare involvement. She is currently the Deputy Chair of Monash Health and has a history of director roles in major healthcare and funds management organizations. Bell expressed enthusiasm about Mesoblast's transition to a commercial entity, especially regarding its potential FDA approval for allogeneic cell therapy. Additionally, Shawn Tomasello is retiring from the Board after four years of service.
Mesoblast Limited (Nasdaq: MESO) reported its operational and financial highlights for the fourth quarter ended June 30, 2022. The company reduced net cash usage for operations by 33% to $13.9 million, with a total of $68.7 million for the year, down 38%. Revenues for Q4 increased 12% to $2.2 million, driven by TEMCELL® HS Inj. royalties. The firm prepares for a Biologics License Application resubmission to the FDA for remestemcel-L to treat children with steroid-refractory graft versus host disease, alongside promising results in COVID-19 and chronic heart failure trials.
On July 11, 2022, Mesoblast Limited (Nasdaq: MESO) announced that its investigational product rexlemestrocel-L for chronic heart failure (CHF) will be featured in a panel discussion on July 14, 2022, hosted by Maxim Group LLC. This therapy aims to reduce inflammation in HFrEF patients, addressing the high rates of cardiac events. With FDA Regenerative Medicine Advanced Therapy and Orphan Drug designations, rexlemestrocel-L is supported by two major placebo-controlled trials. Heart failure affects millions worldwide, presenting a significant market opportunity for Mesoblast's innovative therapies.
Mesoblast Limited (Nasdaq: MESO) announced a webinar on June 16, 2022, discussing chronic low back pain (CLBP) linked to degenerative disc disease.
CEO Silviu Itescu will review the Phase 3 trial results of rexlemestrocel-L, involving 404 patients over three years. Key Opinion Leaders, Douglas P. Beall and Hyun W. Bae, will also present. This event aims to address the treatment landscape and unmet needs in CLBP.
Registration for the webinar is required and will be accessible via Mesoblast's investor page.
Mesoblast Limited (NASDAQ: MESO) reported financial results for Q3 FY2022, highlighting a 40% reduction in operating cash usage to US$15.5 million compared to US$25.8 million last year. Revenue increased 5% to US$2.0 million, with royalties from TEMCELL® HS Inj. contributing US$1.9 million. Notably, cash on hand was US$76.8 million, with potential access to an additional US$40 million. The company is focused on resubmitting its Biologics License Application for remestemcel-L, with a successful mock pre-approval inspection recently completed.
Mesoblast Limited (Nasdaq: MESO) reported significant operational and financial updates for the quarter ending March 31, 2022. Net cash usage for operating activities decreased by 40% to $15.5 million, while revenues rose to $2.1 million, reflecting a 5% increase year-over-year. Notable leadership changes include the appointment of Philip R. Krause, M.D. to the Board, enhancing regulatory expertise. Key updates focus on the imminent BLA resubmission for remestemcel-L, targeting children with steroid-refractory acute graft versus host disease, alongside promising data from ongoing clinical trials in inflammatory bowel disease and COVID-19 ARDS.
On March 23, 2022, Mesoblast Limited (NASDAQ: MESO) announced the appointment of Dr. Philip R. Krause to its Board of Directors. Dr. Krause, former Deputy Director at the FDA’s Office of Vaccines Research, brings extensive regulatory experience to the company. His insights will be crucial as Mesoblast advances its lead products in the market. CEO Dr. Silviu Itescu expressed confidence in Dr. Krause's ability to support ongoing FDA interactions. Mesoblast specializes in allogeneic cell therapies targeting severe inflammatory conditions, leveraging a strong global intellectual property portfolio.
Mesoblast Limited (NASDAQ: MESO) announced financial results and operational updates for Q2 FY2022. The company secured a new $90 million debt facility, with cash on hand at $94.8 million. Notably, net cash usage declined 40% to $18.2 million. Revenues for the quarter totaled $2.4 million, up 7% year-over-year, primarily from TEMCELL® royalties in Japan. Mesoblast is preparing to resubmit its Biologics License Application (BLA) for remestemcel-L in treating steroid-refractory acute graft versus host disease in children, following positive feedback from the FDA regarding potency assays.