FDA Acknowledges Effects on Pain Intensity Favor Rexlemestrocel-L, Confirms 12-Month Reduction in Back Pain Supports Product Efficacy
Mesoblast Limited - American Depositary Shares (MESO)
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Source: GlobeNewswire
NEW YORK, Jan. 18, 2026 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today provided feedback received from the U.S. Food & Drug Administration (FDA) on potential filing of a Biologics License Application (BLA) for its allogeneic cell therapy product rexlemestrocel-L in patients with chronic discogenic low back pain (CLBP). This follows FDA’s Type B meeting review of data from Mesoblast's first randomized controlled Phase 3 trial (MSB-DR003) on pain reduction and relationship to decreased use or elimination of opioids for up to three years following a single rexlemestrocel-L administration. Mesoblast is seeking FDA approval for rexlemestrocel-L based on reduction in CLBP through 12 months. Comparing outcomes between rexlemestrocel-L and placebo from MSB-DR003 trial, FDA acknowledged that the effects on pain intensity appear to favor the active arm. FDA also confirmed that a clinically meaningf
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