Rocket Pharmaceuticals Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits
$RCKT
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 28, 2024
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of
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| Item 8.01. |
Other Events.
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On June 28, 2024, Rocket Pharmaceuticals, Inc. (the “Company”) announced a regulatory
update for KRESLADI™ (marnetegragene autotemcel; marne-cel), a lentiviral (“LV”) vector-based gene therapy to treat severe leukocyte adhesion deficiency-I (“LAD-I”). The U.S. Food and Drug Administration (“FDA”) has issued a Complete Response
Letter (“CRL”) in response to the Company’s Biologics License Application (“BLA”) for KRESLADI™ wherein the FDA requested limited additional Chemistry Manufacturing and Controls (“CMC”) information to complete its review. The Company met with FDA
senior leaders from the Center for Biologics Evaluation and Research to align on the limited scope of additional CMC information needed to support approval of KRESLADITM as quickly as possible. A copy of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this report by reference.
| Item 9.01 |
Financial Statements and Exhibits.
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(d)
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Exhibits
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Exhibit No.
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Description
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Press Release of Rocket Pharmaceuticals, Inc.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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Rocket Pharmaceuticals, Inc.
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Date: June 28, 2024
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By:
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/s/ Aaron Ondrey
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Aaron Ondrey
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Chief Financial Officer
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