This S&P/ASX 200 Index (ASX: XJO) stock has experienced sharp volatility over the past year, with its share price swinging between $1.52 and $3.35.
Mesoblast Ltd (ASX: MSB) shares were amongst the big ASX winners on Thursday, lifting 6.8% to $2.67.
What's driving the recent surge of the ASX 200 healthcare stock, and can it be sustained this time?
One step closer to a breakthrough
After years of underperformance, the ASX 200 healthcare stock rebounded in 2025 as investor confidence returned to Mesoblast's lead therapy, remestemcel-L.
The key question now is whether the company is nearing its first meaningful commercial breakthrough. On Monday, the ASX 200 healthcare stock issued a release that the US Food and Drug Administration (FDA) had acknowledged positive results for its lead therapy.
The regulator indicated that the treatment reduced pain in patients with chronic lower back pain caused by degenerative disc disease. The FDA also noted that significant reductions in opioid use observed in at least one major trial could potentially appear on the product label.
The ASX 200 stock reported that many patients reduced or ceased opioid use for extended periods following treatment.
Sharp sales acceleration
Earlier in the month, the share price of the ASX 200 stock raced to a 52-week high of $3.35, following the release of a sales update.
According to the release, Mesoblast generated gross revenue of US$35.1 million from sales of Ryoncil (remestemcel-L-rknd) in the quarter ended 31 December 2025. That result represented a 60% increase compared with the quarter ended 30 September, highlighting a sharp acceleration in sales momentum.
Despite the positive FDA regulatory update and sales increase, the ASX 200 stock fell this month with 7%. Shares retreated to a two-month low, pointing to technical pressure and profit-taking after a strong rally late last year and at the start of 2026. Sentiment may have also weakened after Executive Director Dr Eric Rose sold roughly 640,000 shares.
Extended clinical trials
Material risks remain. Mesoblast has consumed substantial capital during its prolonged development cycle, repeatedly raising funds to support extended clinical trials and regulatory processes.
The company's history of FDA setbacks has further tested investor patience. Even with approval, the ASX 200 company must still execute on commercialisation, scale sales, and compete in an increasingly crowded cell-therapy market.
Broker sentiment remains bullish
Despite these risks, brokers remain optimistic on the ASX 200 stock. The average 12-month price target for Mesoblast shares sits at $4.11, implying 54% upside from current levels.
TradingView data shows all covering analysts rate the stock a strong buy. Price targets range from $3.07, representing 15% upside, to $5.20, which implies potential gains of 95%.
