MSB 2.08% $1.41 mesoblast limited

Corporate Highlights & Upcoming Milestones

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    Upcoming Milestones in Second Half FY2019:

    Mesoblast intends to initiate BLA filing for marketing authorization of remestemcel-L following its FDA meeting scheduled for April 2019.

    Mesoblast’s partner Tasly is planning to meet with the National Medical Products Administration of China to discuss the regulatory approval pathway for Revascor in China.

    Mesoblast intends to meet with the FDA to discuss the pathway for approval of Revascor for the reduction in GI bleeding in patients with LVADs.

    All patients in Mesoblast’s Phase 3 trial in MPC-06-ID for chronic lower back pain will complete their 12-month assessment for safety and efficacy.

    Corporate Highlights for the Six Months Ended December 31, 2018 (first half FY2019):

    • After demonstrating strong survival benefits through Day 180, Mesoblast held two successful end-of-phase meetings with the FDA covering clinical and manufacturing aspects of the upcoming Biologics License Application (BLA) for remestemcel-L in the US for use in children with steroid-refractory aGVHD.
    • The Company now has a meeting scheduled with the FDA in April 2019 and is on track to subsequently initiate a BLA filing for marketing authorization.
    • Mesoblast’s Phase 3 trial in chronic heart failure completed patient enrollment, with 566 patients randomized to receive Revascor or placebo. The study, conducted across 55 centers in North America, will complete when sufficient primary endpoint events have accrued, which is likely to be within 12 months.
    • Mesoblast completed its transaction with Tasly Pharmaceutical Group (Tasly) to establish a strategic cardiovascular partnership in China, and received US$40 million on closing.
    • Mesoblast and Tasly held their first Joint Steering Committee meeting, with a shared objective to initiate a clinical study in China using similar clinical endpoints and targeting a similar patient population as in Mesoblast’s North American Phase 3 trial. Tasly and Mesoblast will leverage each other’s clinical trial results to support their respective regulatory submissions.
    • The National Institutes of Health (NIH) sponsored 159-patient trial of Revascor in end-stage heart failure patients with a left ventricular assist device (LVAD) achieved a 76% reduction in major gastrointestinal (GI) bleeding events and a 65% reduction in associated hospitalizations. Under the Regenerative Medicine Advanced Therapy (RMAT) designation for this indication, Mesoblast has received guidance from the FDA that reduction in GI bleeding and related hospitalizations is a clinically meaningful outcome that could support product registration.
    • Mesoblast has expanded its partnership with Japan’s JCR Pharmaceuticals Co. Ltd. (JCR) for the treatment of wound healing in epidermolysis bullosa (EB). Having been granted Orphan Regenerative Medical Product designation for EB in October, JCR now intends to seek a label extension for TEMCELL®1 HS. Inj. in Japan for EB beyond its existing approval for the treatment of aGVHD.
    • Management has been expanded to build a commercial team to support the Company’s launch plans for remestemcel-L and operational leadership to drive product life cycle management, commercial manufacturing and regulatory interactions.
    • The Board of Directors is undergoing a structured succession plan and has brought on two new US-based Directors with proven expertise in product commercial launches, reimbursement and health system economics.
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