One of the best performers on the S&P/ASX 200 Index (ASX: XJO) in August was the Mesoblast limited (ASX: MSB) share price.
The biotechnology company's shares recorded a stunning 40.5% gain during the month.
Why did the Mesoblast share price rocket 40% higher in August?
Investors were scrambling to buy the biotechnology company's shares in August due to positive developments relating to its remestemcel-L product candidate.
Remestemcel-L, also known as RYONCIL, is being developed as a treatment for paediatric steroid-resistance acute graft versus host disease (paediatric SR-aGvHD).
SR-aGvHD is an area of extreme need, particularly in vulnerable children under 12 years old where there is no approved therapy. It occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT) and has a very high mortality rate.
Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor.
It is administered to patients in a series of intravenous infusions and is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in SR-aGvHD. This is by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.
What was the positive development?
In August the company had its meeting with the Oncologic Drugs Advisory Committee (ODAC) of the U.S. FDA to discuss remestemcel-L as a potential treatment for paediatric SR-aGvHD.
The good news was that after some initial doubts, the ODAC was supportive of remestemcel-L and gave it the thumbs up.
While this doesn't necessarily guarantee that the U.S. FDA will approve it on 30 September, its opinions have a big sway on product approvals for cancer drugs. In light of this, the odds are certainly in Mesoblast's favour later this month.
Should you invest?
I think Mesoblast is an exciting company and well worth keeping a close eye on.
However, due to its current valuation, I would class it as a hold and would sooner be a buyer of CSL Limited (ASX: CSL) shares.
I think they are trading at a more attractive level after a recent pullback.
