It’s no secret that Mesoblast Ltd [ASX:MSB] has been a breakout mid-cap in 2020.
The stock has seen close to a fivefold (500%) increase in its share price since the March crash. Delivering some astonishing gains to shareholders who stuck with the company.
But the crazy thing is, this biotech’s lead drug isn’t even on the market yet…
RYONCIL, as it’s known, is Mesoblast’s lead product. A drug which has shown promise in treating steroid-refractory acute graft-versus-host disease (SR-aGVHD).
Because today, the company is likely on the cusp of making its next big announcement.
Yea or nay
As outlined in our last update, Mesoblast is awaiting crucial approval from the FDA. A decision that will determine whether they can start marketing RYONCIL in the US.
This verdict was officially slated for 30 September. Which is today, when taking the difference in time zones into account.
For that reason, Mesoblast has gone into a trading halt today. With shares likely to stay frozen until Monday (5 October). No doubt waiting to see what the FDA’s decision will be, and what it will mean for the company moving forward.
As for what the outcome may possibly be, well we can really only speculate.
But as PharmaLive reports, the previous ODAC endorsement is a strong indicator:
‘On August 13, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted “overwhelmingly” in favor [sic] of the efficacy of the drug in pediatric [sic] patients. Although the FDA is not required to follow the advisory committee’s recommendation, it often does.’
So investors and market participants alike will want to keep a close eye on this stock. Keenly awaiting whatever decision the FDA may come to.
After all, if RYONCIL is approved, expect the MSB share price to soar.
The next CSL?
Speculation aside, it is hard to ignore how far Mesoblast has come in 2020.
They are quickly becoming a dominant force on the ASX. A biotech that may end up rivalling the likes of CSL one day. I’m sure current shareholders will be hoping so.
That kind of value would make them a very lucrative stock indeed. Not to mention a household name amongst traders.
But, while we wait to see what comes next for Mesoblast, why not explore other potential high-value investments…
Take our latest ‘high-value small-cap’ report for instance — a deep dive into tiny stocks that have incredible fundamentals.
For Money Morning