Key Developments: Mesoblast Ltd (MBLTY.PK)
26.95USD
17 May 2013
$0.04 (+0.15%)
$26.91
$27.01
$27.01
$26.95
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Latest Key Developments (Source: Significant Developments)
Mesoblast Ltd Issues New Ordinary Shares
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
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
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
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
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
Mesoblast Ltd Not To Pay FY 2012 Final Dividend
Mesoblast Ltd announced that no dividends were paid or declared during the course of the financial year and no dividends are recommended in respect to the financial year ended June 30, 2012 (2011: nil). Full Article
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