Key Developments: Mesoblast Ltd (MSB.AX)

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Latest Key Developments (Source: Significant Developments)

Osiris Therapeutics Inc Announces Agreement For Sale Of Culture-Expanded MSCs Including Prochymal Worth Up To $100 Million Plus Royalties To Mesoblast Ltd's Subsidiary
Thursday, 10 Oct 2013 07:12pm EDT 

Osiris Therapeutics Inc announced that it has entered into an agreement with a wholly owned subsidiary of Mesoblast Ltd for the sale of Osiris' culture-expanded mesenchymal stem cell (ceMSC) business, including Prochymal, in a transaction worth up to $100 million in initial consideration and milestone payments. Additionally, Osiris will receive royalty payments on sales of Prochymal and other products utilizing the acquired ceMSC technology. Summary of the Transaction: Mesoblast has acquired the assets related to Osiris` ceMSC business; Osiris will receive $50 million in consideration for closing and delivery of its ceMSC assets; Osiris is eligible to receive up to an additional $50 million in payments upon Mesoblast achieving certain clinical and regulatory milestones; Mesoblast will assume all future development costs for the ceMSC business; Osiris will receive single to low double-digit royalties on product sales derived from the ceMSC technology; Osiris and Mesoblast have entered into a separate services agreement for continued product advancement and to ensure a seamless transition; Osiris has retained a license to all transferred intellectual property necessary to run its other businesses; and For Osiris, the transaction results in pro forma cash, investments and receivables of approximately $82 million. Osiris expects to record the closing and asset transfer consideration of $51 million in the fourth quarter of fiscal 2013.  Full Article

Mesoblast Ltd Does Not Recommend Final Dividend
Wednesday, 28 Aug 2013 11:48pm EDT 

Mesoblast Ltd announced that no dividends were paid during the course of the financial year. There are no dividends or distributions recommended or declared for payment to members, but not yet paid, during fiscal 2013.  Full Article

Mesoblast Ltd Receives Clearance To Begin Phase 2 Clinical Trial Of Mesenchymal Precursor Cells In Diabetic Nephropathy
Tuesday, 25 Jun 2013 08:48pm EDT 

Mesoblast Ltd announced that it has received approvals from Australian ethics committees to commence a Phase 2 trial evaluating a single intravenous infusion of its allogeneic or “off-the-shelf” adult Mesenchymal Precursor Cells (MPCs) in patients with type 2 diabetes and advanced kidney disease, or diabetic nephropathy. Ethics approvals for the two selected doses were obtained after safety data were reviewed from the ongoing 60-patient Phase 2 trial evaluating a single intravenous infusion of MPCs in people with early type 2 diabetes without kidney disease. The randomized, placebo-controlled, dose-escalating Phase 2 trial will evaluate the safety and efficacy of 150 million or 300 million intravenously-injected MPCs against placebo in 30 people with advanced diabetic nephropathy. Over a 12-week period, the effects of an MPC infusion will be evaluated on kidney function and protein loss, kidney blood flow, glucose control and markers of inflammation.  Full Article

Mesoblast Ltd Announces Grant Of Key Mesenchymal Precursor Cell Patent In Japan
Tuesday, 4 Jun 2013 07:47pm EDT 

Mesoblast Ltd announced that it has been granted a key patent by the Japanese Patent Office. Japanese patent number 5265190 provides Mesoblast with exclusive commercial rights in Japan through to September 2025 to all compositions-of-matter and uses of its Mesenchymal Precursor Cell (MPC) technology platform, irrespective of the MPC tissue source, including bone marrow, adipose, placenta, umbilical cord and dental pulp.  Full Article

Mesoblast Ltd Issues New Ordinary Shares
Wednesday, 13 Mar 2013 06:23pm EDT 

Mesoblast Ltd announced that it has issued 26,970,979 ordinary shares at an issue price of AUD 6.30 per share. The shares issued as a targeted private placement for the purpose of funding on-going operations, specifically the proposed phase 3 clinical trial using MPCs for treatment of degenerative disease of the lumbar spine, new phase 2 clinical trials to broaden the indications for intravenous delivery of MPCs in the treatment of systemic inflammatory conditions, optimization of manufacturing processes and increased product inventory and additional capacity for staff costs and overheads.  Full Article

Mesoblast Ltd Raises AUD 170 Million
Tuesday, 5 Mar 2013 06:03pm EST 

Mesoblast Ltd announced that it has entered into agreements to raise AUD 170 million through an issue of new fully paid shares at AUD 6.30 per share. The shares will be placed to a select group of existing and new global institutional investors and are expected to be issued and funds received on or around March 13, 2013. The intended uses of these funds are for continued development of Mesoblast's Mesenchymal Precursor Cell (MPCs) technology platform, specifically: a Phase 3 clinical trial using MPCs for treatment of degenerative disease of the lumbar spine; new Phase 2 clinical trials to broaden the indications for intravenous delivery of MPCs in the treatment of systemic inflammatory conditions; optimization of MPC manufacturing processes and increased product inventory; and staff and overheads.  Full Article

Mesoblast Ltd Not To Pay H1 2013 Dividend
Sunday, 10 Feb 2013 05:33pm EST 

Mesoblast Ltd announced that there are no dividends being proposed or declared for the first half of fiscal 2013.  Full Article

Mesoblast Ltd Receives FDA Clearance For Phase 2 Clinical Trial Of Mesenchymal Precursor Cells In Patients With Active Rheumatoid Arthritis
Tuesday, 29 Jan 2013 08:26pm EST 

Mesoblast Ltd announced that it has received clearance from the United States Food and Drug Administration (FDA) to commence a Phase 2 clinical trial evaluating a single intravenous infusion of allogeneic, or off-the-shelf, Mesenchymal Precursor Cells (MPCs) for the treatment of active rheumatoid arthritis. The randomized, double-blind placebo-controlled trial is expected to commence during the second quarter 2013, and will recruit across multiple sites in the United States and Australia. The trial will compare the effects of a single intravenous infusion of allogeneic MPCs dosed at 1 or 2 million cells/kg compared with placebo in 48 patients who have had an incomplete or inadequate response to a biologic inhibitor of the TNF-alpha pathway for active rheumatoid arthritis. Safety and effectiveness of the MPC therapy will be assessed at multiple time points with the primary endpoints defined as three months. RA is an autoimmune disease caused by aberrant activation of multiple immune pathways involving both monocytes and T cells, ultimately resulting in joint destruction. Existing biologic treatments target only single immune pathways, resulting in incomplete responses, need for chronic administration, and potentially unacceptable infectious adverse events. In contrast, Mesoblast's MPCs have been shown in preclinical studies to have a broad immunomodulatory mechanism of action (MOA), simultaneously inhibiting T cells and monocytes involved in inflammation and autoimmunity.  Full Article

Mesoblast Ltd Reaches Key Manufacturing Agreement With The United States Food and Drug Administration
Monday, 19 Nov 2012 05:32pm EST 

Mesoblast Ltd announced that it has reached agreement with the United States Food and Drug Administration (FDA) on the manufacturing process to supply its mesenchymal precursor cells (MPC) for Phase 3 clinical trials. In addition, it has established with the FDA a clear pathway for commercial manufacturing supply of its cell therapy products. The agreement was based on acceptance by the FDA of comparability data from Mesoblast's initial set of manufacturing runs for clinical product to be used in the upcoming Phase 3 trial for congestive heart failure. The agreement with the FDA on Mesoblast's manufacturing process applies to supply of MPCs in Phase 3 trials for additional indications.  Full Article

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