The Mesoblast Ltd (ASX: MSB) share price leapt 11.8% to $2.75 in early trading on Thursday after two announcements from the ASX biotech.
Mesoblast released its 1H FY25 results and announced that pricing had been set for its recently approved flagship drug, remestemcel-L, or Ryoncil, in the United States.
The drug will be made available to US clinics for ordering this quarter.
The Mesoblast share price opened at $2.69, up from $2.46 at yesterday's close. The ASX biotech share is currently trading for $2.67, up 8.33%.
Let's check out the 1H FY25 report.
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Mesoblast share price surges on half-yearly results
Here are the highlights of the report:
- Total revenue of US$3.2 million, down from $3.4 million in 1H FY24
- Loss after tax of US$47.9 million compared to US$32.5 million for H1 FY24
- Net Cash Outflow of US$20.7 million, down from US$26.6 million in H1 FY24
- Cash balance of US$38 million and pro-forma cash of approximately US$200 million
What else happened in 1H FY25?
The biggest event during the half was the approval of Ryoncil to treat the devastating steroid-refractory acute graft-versus-host disease (SR-aGvHD) in children aged two years and older.
The Mesoblast share price skyrocketed by almost 70% between 19 December and 2 January after the company announced approval from the United States Food and Drug Administration (FDA).
Mesoblast shares hit a four-year high of $3.37 per share on 2 January.
SR-aGvHD is a life-threatening condition with a high mortality rate.
Approximately 10,000 patients, including 1,500 children, undergo an allogeneic bone marrow transplant every year in the US.
Approximately one in two patients develop aGvHD, and almost half of them do not respond to the current first-line treatment of steroids.
Mesoblast is now collaborating with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) in the US to conduct a pivotal trial of Ryoncil for adult patients with SR-aGvHD.
What did Mesoblast management say?
Dr Silviu Itescu, Chief Executive of Mesoblast, said:
Our FDA approved product Ryoncil will be available in the coming weeks to the children with SRaGvHD in need of life-saving therapy.
The treatment has delivered long-term survival outcomes in these very high-risk patients and we are pleased with the benefits and value that this treatment brings to patients and their healthcare providers at specialized transplant centers across the U.S..
What's next for Mesoblast?
Mesoblast said Ryoncil would become available to clinics over the next few weeks.
The company said the wholesale acquisition cost (WAC) of Ryoncil had been calculated and set at US$194,000 per intravenous infusion.
Ryoncil will be distributed to US treatment centers by cryogenic services provider, Cencora.
In other news, Mesoblast has conducted a pilot study to see whether Ryoncil may be an effective treatment for inflammatory bowel disease, including Crohn's disease.
The study "demonstrated positive outcomes" in adult patients and added to existing Mesoblast data showing Ryoncil can induce early remission in Crohn's disease.
Mesoblast intends to meet with the FDA to discuss another drug, Revascor, to treat chronic heart failure. The FDA has already indicated its support for an accelerated approval pathway.
The company is also enrolling US participants in a confirmatory phase 3 trial of rexlemestrocel-L, which treats chronic lower back pain.
The FDA has approved the design of the trial.
Mesoblast share price snapshot
The Mesoblast share price has risen 768% over the past 12 months.
