RCKT

Kresladi (marnetegragene autotemcel)

FDA PDUFA Target Action Date · Rocket Pharmaceuticals, Inc.

Saturday, March 28, 2026

Approved

approved

Note: Approved March 26, 2026. Accelerated approval for pediatric severe LAD-I. Priority Review Voucher granted. Source: https://www.businesswire.com/news/home/20260326279809/en/Rocket-Pharmaceuticals-Announces-FDA-Approval-of-KRESLADI-for-Pediatric-Patients-with-Severe-Leukocyte-Adhesion-Deficiency-I-LAD-I

Drug Information

Drug Name: Kresladi (marnetegragene autotemcel) (CT.gov)
Application Type: BLA
Indication: Leukocyte Adhesion Deficiency Type 1 (LAD-I)
Approved As: KRESLADI (marnetegragene autotemcel)

Filing Details

Company: Rocket Pharmaceuticals, Inc.
Stock Ticker: RCKT
SEC CIK: 0001281895
Source: Company IR →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Track All FDA Decisions

View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.

View FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-03-21. Report an issue