In a report released yesterday, Jason McCarthy from Maxim Group maintained a Buy rating on Mesoblast, with a price target of $30.00.
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Jason McCarthy has given his Buy rating due to a combination of factors related to Mesoblast’s progress with its heart failure treatment, Revascor. The company has achieved alignment with the FDA on the approval pathway for Revascor in end-stage ischemic heart failure patients with LVADs, following a Type B meeting. This alignment covers critical aspects such as chemistry, manufacturing, controls, and confirmatory trial design, setting the stage for a potential accelerated approval filing by the end of 2025.
Furthermore, the FDA’s support for an accelerated approval pathway is based on the promising data from Revascor’s clinical trials, despite some previous setbacks. The drug has shown significant improvements in challenging endpoints like mortality and LVAD weans, particularly in the ischemic subgroup. This regulatory progress, combined with the potential to address a significant unmet need in a niche yet expandable market, underpins McCarthy’s optimistic outlook on Mesoblast’s stock.
MESO’s price has also changed dramatically for the past six months – from $20.610 to $10.860, which is a -47.31% drop .