FDA extends Rocket Pharma's KRESLADI BLA review to June 30, 2024; no advisory committee needed

ROCKET PHARMACEUTICALS, INC.

FDA extended Priority Review by 3 months to June 30, 2024 to review clarifying CMC information submitted in response to FDA requests.
FDA confirmed no advisory committee meeting will be held for KRESLADI.
CEO Gaurav Shah expressed confidence in collaboration with FDA and commitment to making therapy available quickly.
Phase 1/2 trial showed 100% overall survival at 12 months post-infusion for all nine patients; endpoints met.
KRESLADI (marnetegragene autotemcel) is for severe Leukocyte Adhesion Deficiency-I (LAD-I).

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