Mesoblast Sets Key FDA Meeting for Opioid-Sparing Back Pain Drug
The biotech firm will meet with regulators in December to chart a path for Rexlemestrocel-L, a cell therapy that has shown promise in reducing opioid use.
Mesoblast Ltd. is gearing up for a critical meeting with the U.S. Food and Drug Administration next month to discuss the regulatory pathway for its lead drug candidate, Rexlemestrocel-L, as a potential treatment to reduce opioid use in patients with chronic low back pain.
The Melbourne-based regenerative medicine company announced it will meet with the FDA in December 2025, a pivotal step that could define the commercial future for its allogeneic cell therapy. Investors are closely watching the outcome, which stands as a significant catalyst for the biotech firm, currently valued at a market capitalization of approximately $2.08 billion.
Shares of Mesoblast (NASDAQ:MESO) traded at $15.59 in Tuesday's session. While the stock has seen a wide range over the past year, trading between $8.52 and $22.00, Wall Street analysts have set a consensus price target of $35.00, signaling strong optimism for the drug's potential.
The upcoming discussion with regulators centers on data from an earlier 404-patient Phase 3 trial. In that study, Mesoblast's therapy demonstrated a notable impact on opioid dependency. According to results released by the company, 28% of patients who received a single injection of Rexlemestrocel-L in combination with hyaluronic acid were able to cease using opioids by the 36-month mark. This figure stands in stark contrast to the 8% of patients who achieved opioid cessation in the saline control group.
A clear directive from the FDA could accelerate the timeline for bringing Rexlemestrocel-L to market, tapping into a pressing public health need. The opioid crisis remains a significant challenge in the United States, and effective, non-addictive pain management solutions are in high demand.
Mesoblast’s candidate already holds a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treating chronic low back pain. This designation is intended to expedite the development and review of promising regenerative therapies for serious conditions. As noted in its latest fiscal year report, this status provides benefits such as more frequent meetings with the FDA and eligibility for priority review.
The company is not resting on its laurels while awaiting the meeting. A second, 300-patient confirmatory Phase 3 trial is actively enrolling, with a primary endpoint focused on pain reduction. The completion of this trial, expected this quarter, will provide another crucial dataset to support a potential Biologics License Application (BLA).
The strategic importance of this regulatory engagement cannot be overstated. A favorable outcome would validate Mesoblast's cellular therapy platform and could unlock a substantial market opportunity. Conversely, any request from the FDA for additional, lengthy trials could lead to significant delays and reassessment from investors.
For now, the scheduled discussion represents a critical inflection point for Mesoblast. The meeting's agenda—to gain clarity on the regulatory path forward—is the first step in potentially delivering a novel therapeutic that addresses both chronic pain and the devastating impact of opioid dependency.