The Mesoblast Ltd (ASX: MSB) share price has been on fire over the last 12 months.
During this period, as you can see on the chart below, the biotech company's shares have risen a whopping 54%.
Has the Mesoblast share price peaked?
Given how far the Mesoblast share price has climbed since last year, you would be forgiven for thinking that the gains are now over.
However, one top broker doesn't believe that is the case.
According to a note out of Bell Potter this morning, its analysts have retained their speculative buy rating and $2.00 price target on the company's shares.
This implies a potential upside of approximately 60% from where it closed out yesterday's session.
What did the broker say?
Bell Potter believes it is "make or break" for Mesoblast, with a key regulatory decision due imminently. It explains:
The PDUFA date for remestemcel-L is now only weeks away (2 August 2023) and as expected the MSB share price has begun to rally – most likely in anticipation of approval. The company resubmitted the Biological License Application (BLA) in January 2023 which was formally accepted for review in March. This was followed by a pre license inspection (by 4 FDA inspectors) of the manufacturing process for remestemcel-L at the Lonza manufacturing facility in Singapore in May. The inspection is considered to have gone well and did not result in the issuance of any form 483 (being potential violations of laws regulating drug manufacturing for use in the USA).
Pleasingly, in addition to the above, the broker feels that trial data is supportive of FDA approval. It adds:
The four year survival data for Remestemcel – L indicates a clean safety profile and a survival rate of 49% and we believe this long term survival data along with overwhelming support of physicians should be sufficient to obtain an approval.
The approval of any new class of therapy can never be taken for granted, nevertheless the data package supporting approval on this occasion is substantially stronger than in 2020.
All in all, it looks set to be an interesting period for Mesoblast shares. Stay tuned for its regulatory update when it drops in the coming weeks.
