Key Developments: Mesoblast Ltd (MSB.AX)
5.50AUD
21 May 2013
$0.03 (+0.55%)
$5.47
$5.41
$5.50
$5.40
151,664
604,127
$7.49
$4.22
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
Mesoblast Ltd Enters Into Strategic Alliance With Lonza Group Ltd
Mesoblast Ltd announced that the Company and Lonza Group (SWS: LONN have entered into a strategic alliance for clinical and long-term commercial production of Mesoblast’s off-the-shelf (allogeneic) adult stem cell products. Under the agreement: Lonza will supply Mesoblast’s clinical and long-term commercial MPC product needs globally; Mesoblast can trigger a process requiring Lonza to construct a purpose-built manufacturing facility exclusively for Mesoblast’s marketed products. In return, Mesoblast will purchase agreed quantities of marketed products from the facility; Mesoblast can exercise its right to buy out this manufacturing facility at a pre-agreed purchase price two years after the facility receives regulatory approval; Mesoblast will have exclusive access to Lonza's Cell Therapy facilities in Singapore for the manufacture of allogeneic cell therapy products, subject to certain exceptions; and Lonza will utilize its intellectual property to facilitate reductions in Mesoblast's manufacturing costs and help enable development of enhanced second generation products. Full Article
Mesoblast Ltd Receives Clearance To Begin First European Trial Of Allogeneic Or 'Off-The-Shelf' Stem Cell Treatment For Heart Attacks
Mesoblast Ltd announced that it had received clearance from the European Medicines Agency (EMA) to begin a 225-patient multi-center Phase 2 clinical trial in Europe for its lead cardiovascular product Revascor in conjunction with angioplasty and stent procedures to prevent heart failure after a major heart attack. Revascor is an allogeneic, or "off-the-shelf", adult stem cell product derived from Mesoblast's Mesenchymal Precursor Cell (MPC) platform technology which is being developed for use in a range of cardiovascular diseases including congestive heart failure, chronic angina, and heart attacks (acute myocardial infarction). The placebo-controlled Phase 2 trial, AMICI (Allogeneic Mesenchymal precursor cell Infusion in myoCardial Infarction), is approved under Europe's voluntary harmonization procedure and will initially recruit patients at multiple European sites, including in the United Kingdom, The Netherlands and Belgium. Trial recruitment is subsequently expected to involve sites in additional European nations, Australia, and the United States. The primary endpoint of the study will be safety and efficacy at six months in heart attack patients who will receive either Revascor at one of two doses or placebo. Durability of effect will additionally be monitored for up to 36 months. Full Article
Mesoblast Ltd Not To Pay FY 2011 Final Dividend
Mesoblast Ltd announced that no dividends are being proposed or have been paid for the year ended June 30, 2011. Full Article
First Minimally-Invasive Procedure Performed In Mesoblast Ltd's Phase 2 Stem Cell Trial For Lumbar Disc Repair
Mesoblast Ltd announced that the first minimally-invasive lumbar disc procedure had been successfully performed in the Phase 2 clinical trial of its proprietary adult Mesenchymal Precursor Cell (MPC) product for the treatment of low back pain and degenerative disc disease. The outpatient procedure lasted less than 20 minutes, with the patient fully awake and under light sedation. The patient was shortly discharged and there were no complications. The procedure was undertaken by leading spine surgeon, Kenneth Pettine, M.D., at the Spine Institute and Loveland Surgery Center in Colorado, a United States Spine Center of Excellence. Dr Pettine is a founder of the Spine Institute, an international leader in non-fusion surgery of the spine, and the co-inventor of Medtronic's Maverick artificial lumbar disc device. In preclinical trials, a single minimally invasive injection of Mesoblast's allogeneic MPCs into severely damaged intervertebral discs resulted in significant reversal of the degenerative process, regrowth of disc cartilage, and sustained normalization of disc pathology, anatomy and function for at least six months. Full Article
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