Mesoblast Limited has announced feedback from the U.S. Food & Drug Administration (FDA) regarding its allogeneic cell therapy product, rexlemestrocel-L, for patients with chronic discogenic low back pain (CLBP). The FDA acknowledged that effects on pain intensity favor rexlemestrocel-L based on data from the company's first randomized controlled Phase 3 trial (MSB-DR003), with a clinically meaningful reduction in pain intensity at 12 months supporting product efficacy. The FDA also indicated that results on opioid reduction from at least one adequate and well-controlled trial could be included in the Clinical Studies section of the product labeling. A second randomized controlled Phase 3 trial (MSB-DR004) is currently recruiting in the United States and is expected to complete enrollment in the coming months. Results from the first Phase 3 trial have already been presented.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Mesoblast Limited published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9627670-en) on January 19, 2026, and is solely responsible for the information contained therein.