secwatch.observer — SEC 8-K summary
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Issuer:     ROCKET PHARMACEUTICALS, INC. (RCKT)
CIK:        0001281895
Form:       8-K
Filed at:   2023-10-02T23:59:59+00:00
Accession:  0001140361-23-046302
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts BLA and grants Priority Review for Rocket's RP-L201 gene therapy for severe LAD-I; PDUFA March 31, 2024
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- PDUFA target action date set for March 31, 2024.
- RP-L201 has FDA RMAT, Rare Pediatric, Fast Track, and Orphan Drug designations.
- Rocket eligible for Priority Review Voucher if RP-L201 is approved.
- Phase 1/2 data: 100% overall survival at ≥12 months for all nine patients; symptoms resolved.
- RP-L201 is a lentiviral vector-based gene therapy for severe LAD-I, a fatal childhood immune disorder.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1281895/000114036123046302/0001140361-23-046302-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1281895/000114036123046302/ef20011759_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-23-046302

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