Current Report · Items 7.01, 9.01 · 8-K

Rocket Pharmaceuticals, Inc.

RCKTNASDAQEQUITYCurrent

Regulation FD Disclosure

Filed Sep 15, 2026Accepted Sep 15, 2026, 7:06 AM EDTCIK 1281895Accession 0001140361-26-036563

Company context

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) is a fully integrated commercial-stage biotechnology company developing genetic medicines for rare and life-threatening diseases, with a strategic focus on inherited cardiovascular disorders and additional programs in hematology and immunology. Rocket's cardiovascular portfolio includes three clinical-stage gene therapy programs targeting hypertrophic, arrhythmogenic, and dilated cardiomyopathies, together representing one of the broadest pipelines focused on inherited heart disease. The Company’s integrated platform combines proprietary adeno-associated virus (AAV) manufacturing capabilities and extensive clinical experience in cardiac gene therapy.

Current securities

RCKTNASDAQ · EQUITY · Current

Historical securities (1)

RCKTWNASDAQ · WARRANT · Historical · closed Sep 2, 2026

Recent company filings

Disclosure sections

Items 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 7.01Item 7.01 - Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On September 15, 2026, Rocket Pharmaceuticals, Inc. (the “Company”) issued a press release announcing alignment with the U.S. Food and Drug Administration on continued enrollment and dosing and key elements of the global pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease, including the recalibrated dose, 12-patient pivotal population and established 12-month co-primary endpoints. A copy of the press release is included as Exhibit 99.1 hereto and is incorporated herein by reference. The information under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Filed exhibits (1)

EX-99.1 (by filename) ef20082010_ex99-1.htm

EX-99.1 2 ef20082010_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Rocket Pharmaceuticals Announces FDA Alignment on Path to Complete Pivotal Phase 2 Trial of RP-A501 in Danon Disease FDA confirms pivotal efficacy population of 12 patients, including the first three treated under the modified protocol FDA review of initial safety data supports continued enrollment and dosing under modified protocol FDA confirms established 12-month co-primary endpoints intended to support potential accelerated approval Comprehensive Danon disease program webinar for October 6, 2026, at 4:30 p.m. ET CRANBURY, N.J. - September 15, 2026 - Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, commercial-stage biotechnology company advancing genetic medicines for rare and life-threatening diseases, focused on inherited cardiovascular disorders, today announced alignment with the U.S. Food and Drug Administration (FDA) on continued enrollment and dosing and key elements of the global pivotal Phase 2 trial of RP-A501 for the treatment of Danon disease, including the recalibrated dose, 12-patient pivotal population and established 12-month co-primary endpoints. The clinical data reviewed by…

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