Mesoblast Ltd (ASX: MSB) shares have been volatile over the last year.
The ASX 200 healthcare stock has fluctuated between lows of $1.52 per share and highs of $3.35.
In the last month, it is up 23%.
These massive swings can make it difficult for investors to pinpoint fair value.
The company works in clinical-stage biotechnology. It develops and commercialises allogeneic cellular medicines to treat complex diseases resistant to conventional standards of care.
This includes recently FDA approved product RYONCIL. It is the first FDA-approved donor-derived cell therapy that doctors can use immediately to treat children and teens who develop a severe, steroid-resistant complication after a transplant.
Yesterday, The Motley Fool's Marc Van Dinther covered the company may be close to more regulatory breakthroughs in the US.
Broker Bell Potter has also weighed in with updated guidance on Mesoblast shares, saying this progress towards commercial launch and monetisation is a key value driver.
Here's what the broker had to say.
Image source: Getty Images
2025 a banner year
The broker said 2025 has already been a banner year for Mesoblast. This began with the late December 2024 FDA approval for Ryoncil, quickly followed by a highly successful commercial launch.
This was facilitated by universal medicare coverage from 1 July 2025 and capped off by a product specific J code from 1 October – practically guaranteeing reimbursement for any hospital seeking reimbursement for on label use.
Not surprisingly this virtual guarantee on reimbursement has driven exponential growth in December quarter sales.
Mesoblast is guiding to gross revenues of at least US$30m (vs $21.9m for 1Q FY26), a near 50% increase.
Long term outlook from Bell Potter
Bell Potter also highlighted the long term exclusivity that Mesoblast has.
Ryoncil has 7 years exclusivity from launch in paediatric GvHD and 12 years before any biosimilar (using an MSC) may emerge. The exclusivity period should extend beyond 2037 based on the remaining life of composition of matter and method of use patents.
The broker said based on the growth evident at this point, the market is witness to the birth of the new standard of care for the treatment of inflammation and cytokine release syndrome associated with the graft vs host disease.
Speculative buy for Mesoblast shares
The team at Bell Potter has reiterated its speculative buy recommendation on Mesoblast shares.
It also has a $4.00 price target on the healthcare stock.
This indicates an upside of almost 42% from yesterday's closing price of $2.82.
Elsewhere, TradingView has a 12 month target price of $4.25 (more than 50% upside).
Online brokerage platform Selfwealth lists Mesoblast shares as undervalued by 26%.
