Competitive AdvantageRyoncil's approval as the only drug for patients under 12 could provide a competitive advantage, especially in the 12-18 year-old segment where it overlaps with Jakafi.
Pipeline DevelopmentSignificant potential for Mesoblast in its late-stage pipeline, including heart failure (HF), with potentially two near-term filings, as well as the ongoing P3 in chronic lower back pain (CLBP).
Regulatory RiskFDA approval of Ryoncil represents a watershed moment for Mesoblast, leading to a reduction in revenue risk adjustment and an increase in the 12-month price target.