secwatch.observer — SEC 8-K summary
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Issuer:     ROCKET PHARMACEUTICALS, INC. (RCKT)
CIK:        0001281895
Form:       8-K
Filed at:   2026-09-15T11:06:51+00:00
Accession:  0001140361-26-036563
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Rocket Pharma gets FDA alignment on pivotal Danon trial; 12-patient cohort path clear
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- FDA confirms 12-patient pivotal population for RP-A501; first 3 treated under modified protocol count toward it.
- Recalibrated dose 3.8e13 GC/kg; no thrombotic microangiopathy or capillary leak in first 3 patients.
- Co-primary endpoints: myocardial LAMP2 expression and 10% reduction in left ventricular mass index at 12 months, supporting potential accelerated approval.
- Company expects to complete dosing of remaining 9 patients by mid-2027.
- Virtual investor webinar on Danon disease program scheduled for Oct 6, 2026 at 4:30 p.m. ET.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1281895/000114036126036563/0001140361-26-036563-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1281895/000114036126036563/ef20082010_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-036563

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