Mesoblast (ASX:MSB) Is Down 6.4% After Encouraging FDA Feedback On Back Pain Cell Therapy Data – Has The Bull Case Changed?

Simply Wall St.01-22

In January 2026, Mesoblast reported that the FDA’s review of Phase 3 data for its cell therapy rexlemestrocel-L in chronic discogenic low back pain found pain outcomes favoring the active treatment ...

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The FDA also indicated that robust opioid reduction data from Mesoblast’s trial might be reflected in product labeling, highlighting the therapy’s potential relevance to chronic pain management during the U.S. opioid crisis. Next, we’ll examine how this encouraging FDA feedback on rexlemestrocel-L’s pain and opioid-use outcomes shapes Mesoblast’s broader investment narrative. AI is about to change healthcare. These 109 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10b in market cap - there's still time to get in early.AdvertisementWhat Is Mesoblast's Investment Narrative?For Mesoblast, the big picture you need to buy into is that its proprietary cell therapies can transition from high‑burn R&D projects into commercially relevant products, with rexlemestrocel‑L in chronic low back pain and Ryoncil as early proof points. The latest FDA feedback on rexlemestrocel‑L looks material for the short term: it clarifies that 12‑month pain data could underpin a future BLA and that opioid‑reduction outcomes might feature in the label, which strengthens the near‑term catalyst around the ongoing confirmatory Phase 3 trial. At the same time, the company remains lossmaking, is reliant on external funding despite a new US$75,000,000 facility, and recently raised US$9.48 million via a shelf offering, so execution risk and future dilution are still front and center. Recent share price weakness suggests the market is still weighing those trade‑offs carefully. However, investors also need to weigh one particular risk that is easy to underestimate.\n\nDespite retreating, Mesoblast's shares might still be trading above their fair value and there could be some more downside. Discover how much.Exploring Other PerspectivesASX:MSB 1-Year Stock Price Chart Twenty Simply Wall St Community fair value views span roughly US$0.18 to US$50, underlining just how far apart expectations can be. Against that backdrop, the recent FDA feedback on rexlemestrocel‑L becomes a key reference point for how that spread might eventually narrow as regulatory outcomes and funding needs become clearer.Explore 20 other fair value estimates on Mesoblast - why the stock might be a potential multi-bagger!Build Your Own Mesoblast NarrativeDisagree with this assessment? Create your own narrative in under 3 minutes - extraordinary investment returns rarely come from following the herd.A great starting point for your Mesoblast research is our analysis highlighting 2 key rewards that could impact your investment decision.Our free Mesoblast research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Mesoblast's overall financial health at a glance.Curious About Other Options?These stocks are moving-our analysis flagged them today. Act fast before the price catches up:Find companies with promising cash flow potential yet trading below their fair value.These 11 companies survived and thrived after COVID and have the right ingredients to survive Trump's tariffs. Discover why before your portfolio feels the trade war pinch.The end of cancer? These 29 emerging AI stocks are developing tech that will allow early identification of life changing diseases like cancer and Alzheimer's.  This article by Simply Wall St is general in nature. We provide commentary based on historical data\n    and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your\n    financial situation. We aim to bring you long-term focused analysis driven by fundamental data.\n    Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.\n    Simply Wall St has no position in any stocks mentioned.New: Manage All Your Stock Portfolios in One PlaceWe've created the ultimate portfolio companion for stock investors, and it's free.• Connect an unlimited number of Portfolios and see your total in one currency• Be alerted to new Warning Signs or Risks via email or mobile• Track the Fair Value of your stocksTry a Demo Portfolio for FreeHave feedback on this article? Concerned about the content? Get in touch with us directly. 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