Insmed Incorporated filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
$INSM
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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): November 18, 2025
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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(Address of principal executive offices)
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Registrant’s telephone number, including area code: (908 ) 977-9900
Not Applicable
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which
registered
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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 (17 CFR 230.405) or Rule 12b-2 of the
Securities Exchange Act of 1934 (17 CFR 240.12b-2).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised
financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| ITEM 7.01 — |
Regulation FD Disclosure.
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On November 18, 2025, Insmed Incorporated (the “Company”) issued a press release announcing that the European Commission (the “EC”) has approved BRINSUPRI® (brensocatib 25 mg tablets) for the treatment of non-cystic
fibrosis bronchiectasis (“NCFB”) in patients 12 years of age and older with two or more exacerbations in the prior 12 months. A copy of the press release is attached hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated
herein by reference.
The information contained in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a
filing.
| ITEM 8.01 — |
Other Events.
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On November 18, 2025, the Company announced that the EC has approved BRINSUPRI (brensocatib 25 mg tablets) for the treatment of NCFB in patients 12 years of age and older with two or more exacerbations in the prior 12
months.
| 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 issued by Insmed Incorporated on November 18, 2025.
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104
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Cover Page Interactive Date 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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Dated: November 18, 2025
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INSMED INCORPORATED
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By:
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/s/ Michael A. Smith
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Name:
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Michael A. Smith
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Title:
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Chief Legal Officer and Corporate Secretary
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