secwatch.observer — SEC 8-K summary
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Issuer:     ROCKET PHARMACEUTICALS, INC. (RCKT)
CIK:        0001281895
Form:       8-K
Filed at:   2024-06-28T23:59:59+00:00
Accession:  0001140361-24-031749
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rocket Pharma receives FDA Complete Response Letter for KRESLADI BLA; limited CMC info requested
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- FDA issued Complete Response Letter for KRESLADI (marne-cel) BLA; requested limited additional CMC information.
- Company met with FDA CBER senior leaders to align on scope of additional CMC info to support approval expeditiously.
- Phase 1/2 data: 100% overall survival at 12 months in 9 patients; all endpoints met; no treatment-related serious AEs.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1281895/000114036124031749/0001140361-24-031749-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1281895/000114036124031749/ef20031912_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-031749

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