Kresladi (marnetegragene autotemcel) PDUFA Date (Rocket Pharmaceuticals)
FDA PDUFA decision date for Kresladi (marnetegragene autotemcel) is March 28, 2026. Developed by Rocket Pharmaceuticals. Indication: Leukocyte adhesion deficiency type I (LAD-I). Current status: Verifying.
Indication
Leukocyte adhesion deficiency type I (LAD-I)
Notes
Breakthrough therapy designation. Ultra-rare disease with no approved treatments.
Regulatory details
- Company: Rocket Pharmaceuticals
- Therapeutic area: Rare Disease / Cell & Gene Therapy
- Application type: BLA
- Review type: Priority
- PDUFA date: 2026-03-28
- Outcome: Pending