The Mesoblast Ltd (ASX: MSB) share price shot out of the gates on Tuesday, opening at 80 cents per share and rising to an intraday peak of 88.5 cents within the first two hours of trading.
The intraday high represents a 59.45% gain over the closing price of 55.5 cents last Thursday, prior to the market shutdown for the Easter long weekend.
At the time of writing, the Mesoblast share price has settled back to 87 cents per share.
What's the news from Mesoblast today?
The only news from the biotech company today is a non-price-sensitive announcement relating to a change in substantial holding.
That's for United States investor Gregory George and G to the Fourth Investments.
The notice advised a collective stake increase from 10.23% to 11.99% last Thursday.
There's no other news today.
However, Mesoblast did have a big announcement last week that sent its share price soaring.
Let's recap.
What's pushing the Mesoblast share price higher?
Mesoblast requested a pause in trading last Tuesday morning before releasing some big news.
The company announced that the US Food and Drug Administration (FDA) had informed it that after reviewing the clinical data from its Phase 3 study, there appeared to be sufficient evidence to support Mesoblast's submission for remestemcel-L to treat kids with steroid-refractory acute graft versus host disease (SR-aGVHD).
Remestemcel-L is being developed for inflammatory diseases in children and adults, including steroid-refractory acute graft versus host disease, and biologic-resistant inflammatory bowel disease.
CEO Silviu Itescu said the company would now refile its Biologics License Application (BLA). This will happen in the June quarter after the company addresses outstanding product characterisation matters.
Silviu said:
The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD.
What is remestemcel-L?
This is the drug that Mesoblast has been trying to get approved for the past three-and-a-half years.
There was much excitement in mid-2020 while Mesoblast was awaiting the FDA's first decision on its flagship drug, also known as Ryoncil.
This can be seen in the Meosblast share price chart below.
Remestemcel-L has FDA Fast Track designation, a process to facilitate the development and speedy
review of therapies for serious conditions that fill unmet medical needs.
It also has Priority Review designation, which is given to drugs that treat a serious condition and provide a significant improvement in safety or effectiveness over existing treatments.
Survival outcomes have not improved for 20 years for children or adults with the most severe forms of SR-aGVHD.
As you can see, the Mesoblast share price was trading above $5 per share back in those days.
The market was shocked when the FDA knocked back the application in October 2020.
Mesoblast worked with the FDA for two years to address the issues. It resubmitted its Biologics License Application (BLA) resubmission for remestemcel-L in the treatment of children in March 2023.
But the FDA knocked it back again in August. The Mesoblast share price spiralled down almost 60% after the FDA said it needed more data to support marketing approval for remestemcel-L for kids.
Mesoblast then sat down with the FDA in what is called a Type A meeting.
The FDA advised the company that the key remaining issue for pediatric approval was providing further evidence that the potency assay will assure the consistent efficacy of the commercial product.
Mesoblast later provided the FDA with new data from a second potency assay.
The company said:
The new data show that the RYONCIL product made with the current manufacturing process that
has undergone successful inspection by FDA, demonstrates greater potency than the earlier
generation product, providing context to its greater impact on survival.
Mesoblast has been waiting for the FDA to respond to the new data ever since.
Mesoblast share price snapshot
The Mesoblast share price is down 13.3% over the past 12 months.
However, in the year to date, it is up 174%.
