Mesoblast Wins FDA Backing on Pain and Opioid-Reduction Data for Rexlemestrocel-L in Chronic Low Back Pain

An announcement from Mesoblast ( (MESO) ) is now available.

On January 18–19, 2026, Mesoblast reported that the U.S. Food and Drug Administration has acknowledged Phase 3 data showing that its allogeneic cell therapy rexlemestrocel-L appears to provide superior pain intensity reduction versus placebo in chronic discogenic low back pain through 12 months, and that such a clinically meaningful 12‑month pain reduction can support product efficacy for a potential Biologics License Application. The agency also indicated that robust evidence of reduced or eliminated opioid use from Mesoblast’s first Phase 3 trial could be reflected in product labeling’s Clinical Studies section, bolstering the therapy’s potential positioning as a non-opioid option in a market heavily shaped by the U.S. opioid crisis. A second 300‑patient confirmatory Phase 3 study in chronic low back pain due to inflammatory degenerative disc disease is now more than half enrolled across 40 U.S. sites and expected to complete enrollment within about three months, positioning Mesoblast to advance toward a filing under its existing Regenerative Medicine Advanced Therapy designation and potentially strengthen its foothold in the emerging field of regenerative, non‑opioid pain treatments.

The most recent analyst rating on (MESO) stock is a Hold with a $21.50 price target. To see the full list of analyst forecasts on Mesoblast stock, see the MESO Stock Forecast page.

Spark’s Take on MESO Stock

According to Spark, TipRanks’ AI Analyst, MESO is a Neutral.

Mesoblast’s overall stock score reflects a company with strong growth potential but significant financial challenges. The earnings call provided positive insights into market access and product launches, which are promising for future growth. However, financial performance and valuation concerns weigh down the score, with technical indicators suggesting caution due to overbought conditions.

To see Spark’s full report on MESO stock, click here.

More about Mesoblast

Mesoblast Limited is an Australia-headquartered biotechnology company specializing in allogeneic, off-the-shelf cellular medicines targeting severe and life-threatening inflammatory conditions. Leveraging a proprietary mesenchymal lineage stromal cell platform, it has developed Ryoncil, the first FDA-approved mesenchymal stromal cell therapy for pediatric steroid‑refractory acute graft versus host disease, and is advancing additional indications including adult SR-aGvHD, biologic‑resistant inflammatory bowel disease, heart failure and chronic low back pain. The company operates manufacturing and development sites in Australia, the United States and Singapore, holds an extensive global patent estate extending to at least 2044 in major markets, and maintains commercial partnerships across Japan, Europe and China while being dual listed on the ASX and Nasdaq.

Average Trading Volume: 209,176

Technical Sentiment Signal: Buy

Current Market Cap: $2.21B

For an in-depth examination of MESO stock, go to TipRanks’ Overview page.