MESOBLAST LTD (MESO) Form 6-K — Jun 30, 2026
Mesoblast Limited announced it has received a Biologics License Application (BLA) filing number from the FDA and requested a modular review for rexlemestrocel-L in end-stage heart failure patients with LVADs. The therapy aims to prevent life-threatening gastrointestinal bleeding and already holds Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations. The company cited new FDA guidance on regulatory flexibility for orphan diseases with high mortality as a positive factor for the review process. There are approximately 2,500 LVADs implanted annually in the US, representing a targeted population for this allogeneic cellular medicine.
Key figures
- Ip Protection Year
- 2044
- Trial Patients LVAD
- 159
- Us Annual LVADImplants
- 2,500
- Trial Patients Class II III
- 565
- Us Annual End Stage Progression
- 100,000
- Granted Patents Or Applications
- >1,000
- Us Chronic Heart Failure Patients
- 6.5 million
- Lvad Destination Therapy Percentage
- 80%
- Global Chronic Heart Failure Patients
- 26 million
- Ischemic Recovery Likelihood Reduction
- 76%
AI analysis
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