European Commission clears Insmeds BRINSUPRI for NCFB treatment

Rhea-AI Filing Summary

Insmed Incorporated announced that the European Commission has approved its drug BRINSUPRI (brensocatib 25 mg tablets) to treat non-cystic fibrosis bronchiectasis in certain younger and adult patients. The approval covers patients 12 years of age and older who have experienced two or more exacerbations in the prior 12 months, addressing a population with recurrent respiratory flare-ups. Insmed disclosed the news in connection with a press release, which is included as an exhibit to the report.

Positive

• European Commission approval of BRINSUPRI (brensocatib 25 mg tablets) for treating non-cystic fibrosis bronchiectasis in eligible patients, marking a major regulatory milestone for Insmed.

Negative

• None.

Insights

Biopharma regulatory analyst

European Commission approval of BRINSUPRI is a major regulatory milestone for Insmed.

The report states that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for treating non-cystic fibrosis bronchiectasis in patients 12 years and older with two or more exacerbations in the prior 12 months. This moves brensocatib from a development-stage asset into an approved therapy within this jurisdiction, which can be an important step in the product’s lifecycle.

European Commission approval typically allows marketing across participating European markets once standard national steps are satisfied, potentially expanding access to patients who fit the described criteria. While the filing does not include revenue projections or launch details, obtaining this authorization can be a key prerequisite for future commercial activity and reimbursement discussions.

The company highlights the approval via a press release attached as an exhibit dated November 18, 2025. Subsequent disclosures may provide more detail on pricing, commercialization plans, and early uptake, which will shape the ultimate financial significance of this new indication.

8-K Event Classification

3 items: 7.01, 8.01, 9.01

3 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

Virginia	000-30739	54-1972729
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

700 US Highway 202/206 Bridgewater, New Jersey		08807
(Address of principal executive offices)		(Zip Code)

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):

☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.01 per share	INSM	Nasdaq Global Select Market

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.

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.

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.

(d) Exhibits

Exhibit No.		Description
99.1		Press release issued by Insmed Incorporated on November 18, 2025.
104		Cover Page Interactive Date File (embedded within the Inline XBRL document).

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.

Dated: November 18, 2025	INSMED INCORPORATED
	By:	/s/ Michael A. Smith
	Name:	Michael A. Smith
	Title:	Chief Legal Officer and Corporate Secretary

FAQ

What did Insmed (INSM) announce in this 8-K filing?

Insmed reported that the European Commission has approved BRINSUPRI (brensocatib 25 mg tablets) for treating non-cystic fibrosis bronchiectasis in eligible patients.

For which patients is BRINSUPRI approved according to Insmeds 8-K?

BRINSUPRI is approved for patients with non-cystic fibrosis bronchiectasis who are 12 years of age and older and have had two or more exacerbations in the prior 12 months.

Which regulator approved BRINSUPRI for Insmed (INSM)?

The European Commission approved BRINSUPRI (brensocatib 25 mg tablets) for the specified non-cystic fibrosis bronchiectasis patient group.

What drug is highlighted in Insmeds latest 8-K filing?

The filing highlights BRINSUPRI (brensocatib 25 mg tablets), which has been approved by the European Commission for certain non-cystic fibrosis bronchiectasis patients.

Does the Insmed 8-K include additional details on BRINSUPRI?

The report notes that additional information is provided in a press release attached as Exhibit 99.1, which discusses the European Commission approval of BRINSUPRI.

When did Insmed announce the European Commission approval of BRINSUPRI?

Insmed announced the approval on November 18, 2025, as stated in the report and the referenced press release.