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KRESLADI (marnetegragene autotemcel (RP-L201))

Rocket Pharma · $RCKT

Priority Review Breakthrough Therapy Orphan Drug Rare Pediatric Disease BLA

PDUFA Date

March 28, 2026

Time Remaining

4 days

Review Type

Priority (6 mo)

65%

Baseline PoA

Resubmission penalty
applied (prior CRL)

Dynamic PoA

Coming soon
xAI Sentiment

Indication

Leukocyte adhesion deficiency-I (LAD-I)

Key Notes

BLA resubmission accepted October 2025. Gene therapy for rare immune deficiency. Would be Rocket Pharma's first FDA-approved product.

⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

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