Mesoblast (MESO) Spikes On FDA’s Endorsement For Accelerated Approval

Mesoblast Limited (NASDAQ: MESO) is witnessing a significant surge in its stock during the current trading session, experiencing a noteworthy increase of 31.16% to reach $2.82 as per the latest updates. This surge follows a pivotal regulatory approval development disclosed by the company.

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Rexlemestrocel-L, an allogeneic mesenchymal precursor cell (MPC) product that Mesoblast disclosed, has received support from the FDA for an expedited clearance process. The intended audience for this approval procedure consists of patients with end-stage ischemic heart failure who have been equipped with left ventricular assist devices (LVADs) with decreased ejection fractions (HFrEF).

As part of its Type B meeting with Mesoblast on February 21, 2024, the FDA supported the existing Regenerative Medicine Advanced Therapy (RMAT) classification for rexlemestrocel-L (marketed as Revascor). Mesoblast plans to request a pre-Biologics License Application (BLA) meeting in response to FDA feedback. MESO will discuss a variety of topics, including data presentation, timing, and FDA requirements for submitting an expedited approval application.

Each year, more than 100,000 Americans suffer from end-stage heart failure. This is a significant number of patients. LVAD implantation, a life-prolonging therapy, is a common procedure, particularly among patients with ischemic HFrEF.  Patients receiving LVADs as destination therapy commonly suffer from ischemic HFrEF, which is associated with challenges in LV functional recovery and heightened mortality rates.

Mesoblast conducted the placebo-controlled LVAD-MPC Study #2 involving 70 patients with end-stage ischemic HFrEF, who were randomized to receive either rexlemestrocel-L or placebo at the time of LVAD implantation surgery. The study revealed promising outcomes, with ischemic patients treated with rexlemestrocel-L demonstrating normalization of inflammatory cytokine IL-6 levels, improved ability to be weaned from LVAD support, and reduced mortality rates compared to controls.

The FDA’s reply indicates that there is potential for the data to demonstrate clinical benefit and they could meet the requirements for expedited approval. Mesoblast is committed to pushing rexlemestrocel-L as a possible treatment option for patients with end-stage ischemic HFrEF who have received LVAD implantation, as evidenced by its desire to hold additional conversations with the FDA.