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): February 24, 2025

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

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):

Securities registered pursuant to Section 12(b) of the Act:

 

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. ☐

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ITEM 8.01 — Other Events.

On February 24, 2025, Insmed Incorporated (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) does not currently plan to hold an advisory committee meeting to discuss the Company’s New Drug Application (“NDA”) for brensocatib for patients with non-cystic fibrosis bronchiectasis. The FDA previously granted the Company’s request for priority review and set a target action date of August 12, 2025 under the Prescription Drug User Fee Act.

ITEM 7.01 — Regulation FD Disclosure.

On February 24, 2025, the Company issued a press release announcing that the FDA does not currently plan to hold an advisory committee meeting to discuss the Company’s NDA for brensocatib for patients with non-cystic fibrosis bronchiectasis. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information contained in 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 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 9.01 — Financial Statements and Exhibits.

(d) Exhibits

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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