Shares of Mesoblast Limited MESO have soared 80% in one month following the FDA approval of remestemcel-L as the only approved therapy for steroid-refractory acute graft versus host disease (SR-aGVHD) in children aged two months and older, including adolescents and teenagers. The drug has a novel mechanism of action and will be marketed under the brand name Ryoncil in the United States.
The approval gave Mesoblast its first approved product in its portfolio. Sales of the drug are expected to provide the company with a steady source of income. The company is currently gearing up to launch the product in the U.S. market.
SR-aGVHD is a devastating condition that has an extremely poor prognosis. Each year in the United States, around 10,000 patients, including 1,500 children, undergo allogeneic bone marrow transplants. About 50% develop aGvHD, and nearly half of these cases are steroid-resistant.
In the past six months, shares of Mesoblast have skyrocketed 202.9% against the industry’s 4.8% decline.
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The FDA approval was based on positive results from a phase III study of remestemcel-L in children with SR-aGvHD, 89% of whom had high-severity Grade C or Grade D disease. Among the patients treated with the drug, 70% achieved an overall response by Day 28, a measure that predicts survival in aGVHD.
Furthermore, no patient had their Ryoncil treatment discontinued or interrupted due to any laboratory abnormality, and more than 85% of patients completed the full course without interruption.
Mesoblast is also looking to expand Ryoncil’s label to include the treatment of adult patients with SR-aGVHD. A late-stage study is currently evaluating the drug in this patient population. Additionally, the company is also evaluating Ryoncil in a mid-stage study for certain inflammatory bowel disease indications: ulcerative colitis and Crohn’s colitis.
Other Clinical Programs in MESO’s Pipeline
Mesoblast has another late-stage pipeline candidate, rexlemestrocel-L, which is being developed for heart failure and chronic low back pain (CLBP).
In March 2024, MESO announced that the FDA supports an accelerated approval pathway for rexlemestrocel-L in patients with end-stage ischemic heart failure with reduced ejection fraction (HFrEF) and a left ventricular assist device. The company plans to hold a meeting with the FDA to discuss the next steps in filing for the candidate for the HFrEF indication in children and adults. A potential approval will further strengthen Mesoblast’s commercial portfolio and form another source of revenue generation.
In July 2024, Mesoblast initiated patient enrollment in its late-stage study of rexlemestrocel-L in patients with CLBP due to inflammatory degenerative disc disease of less than five years duration. The company had previously reached alignment with the FDA regarding the CLBP study design. The primary endpoint of the study is pain reduction after 12 months of treatment. Key secondary endpoints include improvement in quality of life, function and reduced opioid usage.
Mesoblast Limited Price and Consensus
Mesoblast Limited price-consensus-chart | Mesoblast Limited Quote
MESO’s Zacks Rank & Other Stocks to Consider
Mesoblast currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Spero Therapeutics SPRO. While CSTL and SPRO sport a Zacks Rank #1 (Strong Buy) each, CTMX carries a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, 2024 estimates for Castle Biosciences have improved from a loss of 59 cents per share to earnings of 34 cents. During the same timeframe, loss per share estimates for 2025 have narrowed from $2.15 to $1.84. In one month, shares of Castle Biosciences have lost 12%.
CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.
In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents during the same timeframe. In one month, Spero’s shares have lost 8.5%.
SPRO’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 94.42%.
In the past 60 days, estimates for CytomX Therapeutics’ 2024 loss per share have narrowed from 29 cents to 5 cents. Estimates for 2025 loss per share have narrowed from 56 cents to 35 cents during the same timeframe. In one month, CTMX stock has lost 17.8%.
CytomX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.
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Mesoblast Limited (MESO) : Free Stock Analysis Report
CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report
Spero Therapeutics, Inc. (SPRO) : Free Stock Analysis Report
Castle Biosciences, Inc. (CSTL) : Free Stock Analysis Report
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