secwatch.observer — SEC 8-K summary
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Issuer:     ROCKET PHARMACEUTICALS, INC. (RCKT)
CIK:        0001281895
Form:       8-K
Filed at:   2024-02-13T23:59:59+00:00
Accession:  0001140361-24-007462
Event type: regulatory
Sentiment:  neutral
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1281895/000114036124007462/0001140361-24-007462-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1281895/000114036124007462/ef20021579_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-007462

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer