Short answer
ROCKET PHARMACEUTICALS, INC. (RCKT) filed an 8-K current report with the SEC on September 15, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item EX-99.1 (Exhibit EX-99.1). Item 7.01 provides only the filing’s standard Regulation FD disclaimer.
ROCKET PHARMACEUTICALS, INC. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Item 7.01 provides only the filing’s standard Regulation FD disclaimer
- No substantive company disclosure or investor-actionable information appears in the provided text
Item EX-99.1 · Exhibit EX-99.1
- FDA alignment preserves RP-A501’s pivotal Phase 2 path and potential accelerated approval strategy in Danon disease
- Pivotal population set at 12 male patients receiving 3.8 × 10¹³ GC/kg; first three patients count toward efficacy population
- Nine additional patients remain; Rocket expects dosing completion by mid-2027
- Initial safety review supported continued enrollment, with no observed thrombotic microangiopathy or capillary leak syndrome
- Co-primary 12-month endpoints remain myocardial LAMP2 expression and 10% left-ventricular mass-index reduction
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
Other ROCKET PHARMACEUTICALS, INC. 8-K filings
Get the next RCKT 8-K as it lands
Follow RCKT for push alerts, or ask the research agent what this filing means.