On January 18 2026 the U.S. Food & Drug Administration reviewed data from Mesoblast Limited’s first randomized, controlled Phase 3 trial (MSB‑DR003) of rexlemestrocel‑L for chronic discogenic low back pain and confirmed that the treatment arm produced a clinically meaningful reduction in pain intensity at 12 months compared with placebo.
The trial enrolled 404 patients and showed that, in addition to the 12‑month pain reduction, more than three‑fold as many patients in the treatment group had ceased all opioid use by 36 months versus saline controls. The FDA’s feedback indicates that the opioid‑cessation data could be incorporated into the product labeling, a significant step given the ongoing opioid crisis and the public‑health emphasis on non‑opioid pain therapies.
Mesoblast’s rexlemestrocel‑L has already received Regenerative Medicine Advanced Therapy (RMAT) designation, which provides priority review and rolling‑submission benefits. The FDA’s acknowledgment of both pain‑reduction and opioid‑cessation outcomes strengthens the case for a Biologics License Application (BLA) and supports the company’s strategy to bring the product to market under the RMAT pathway.
The company is also advancing a second Phase 3 confirmatory study (MSB‑DR004) that is over 50 % enrolled and aims for a 300‑patient target within the next three months. Successful completion of this trial will provide the additional data needed for the BLA and could accelerate regulatory approval.
Market reaction to the FDA feedback has been mixed. Shares dipped 0.4 % in early trading, fell 10 % from a recent high, and were down 2 % midday, reflecting a 15 % decline over the past week. Jefferies upgraded Mesoblast to Buy, citing the regulatory milestone, while CEO Silviu Itescu highlighted the dual benefit of pain relief and opioid reduction, noting that the drug “could offer a powerful solution for management of chronic inflammatory back pain with the added potential to contribute to the administration’s goals of opioid reduction or cessation.”
The FDA’s positive feedback is a regulatory milestone that could open a new revenue stream for Mesoblast, but investors remain cautious about the timing of the BLA filing, the finality of opioid‑labeling claims, and recent director selling. These factors temper enthusiasm, underscoring the need for continued progress in the confirmatory trial and clear communication of labeling outcomes.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.