Mesoblast Touts High Survival Rates For FDA-Approved Cell Therapy
Mesoblast Limited (NASDAQ: MESO) shares are down during Thursday’s premarket session after the company provided data presented at the Tandem Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for Blood and Marrow Transplant Research (CIBMTR).
In a press release on Wednesday, it was noted that Ryoncil has shown high survival rates in patients with steroid-refractory acute graft versus host disease, emphasizing the need for earlier intervention.
Importance Of Using Ryoncil Early
The study results showed that Ryoncil (remestemcel-L-rknd) achieved similarly high survival outcomes in steroid-refractory acute graft-versus-host disease (SR-aGvHD), irrespective of whether used in children or adults, as second or third line, and in ruxolitinib-naive or resistant patients.
Ryoncil is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD).
Of the 53 patients with SR-aGvHD who received Ryoncil as ≥ third-line treatment under the Emergency Investigational New Drug (EIND) program (89% grade III/IV disease), 15% died before being able to complete a full treatment course of Ryoncil compared with only 2% of patients who received Ryoncil as second-line in the Phase 3 trial MSB-GVHD001.
These results emphasize the importance of using Ryoncil as early as possible after steroid resistance in acute GVHD to complete a full treatment course and maximize survival.
Additionally, adult patients in the EIND program of Ryoncil had at least as favorable day 100 survival as children in the EIND program, providing strong support and rationale for the planned pivotal trial of early use of Ryoncil as part of the second-line treatment regimen in adults with severe SR-aGvHD.
The trial is expected to commence enrollment this quarter after protocol approval by the trial’s central Institutional Review Board (IRB). If successful, the trial will support label extension of Ryoncil for use in adults – a population approximately three times the size of the pediatric SR-aGvHD population.
Technical Analysis
The stock is currently trading 1.8% above its 20-day simple moving average (SMA) but is 2.3% below its 50-day SMA, indicating some short-term strength while struggling with medium-term resistance.
Over the past 12 months, shares have decreased by 1.29% and are currently positioned closer to their 52-week highs than lows.
The RSI is at 54.28, which is considered neutral territory, suggesting that the stock is neither overbought nor oversold. Meanwhile, MACD is above its signal line, indicating bullish momentum for the stock.
The combination of neutral RSI and bullish MACD suggests mixed momentum.
- Key Resistance: $19.50
- Key Support: $17.50
MESO Price Action: Mesoblast shares were down 3.06% at $17.73 during premarket trading on Thursday.
Photo by Gorodenkoff via Shutterstock
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
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