BRINSUPRI Receives FDA Approval; Insmed Announces Webcast and Slides

Rhea-AI Filing Summary

Insmed announced FDA approval of BRINSUPRI (brensocatib) 10 mg and 25 mg tablets, an oral once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. The company attached a press release and an approval presentation as Exhibits 99.1 and 99.2 and will host a conference call with a live webcast to discuss the approval. The filing notes the Item 7.01 materials are not deemed "filed" for purposes of Section 18. The report does not include financial results, revenue guidance, launch timing, or other commercial details.

Positive

• FDA approval of BRINSUPRI for non-cystic fibrosis bronchiectasis in adults and children 12 years and older.
• Approval specifies oral once-daily dosing with 10 mg and 25 mg tablet strengths.
• Company scheduled a conference call and live webcast and filed a press release and presentation as Exhibits 99.1 and 99.2.

Negative

• No financial information or revenue guidance is included in the filing.
• Materials in Item 7.01 are explicitly not deemed "filed" for purposes of Section 18, which may limit incorporation by reference into other filings.

Insights

Financial Analyst

TL;DR: FDA approval is a material positive that creates a commercial pathway, but the filing provides no financial details or launch guidance.

Insmed's disclosure confirms regulatory clearance to market BRINSUPRI for non-cystic fibrosis bronchiectasis in patients aged 12 and older with available 10 mg and 25 mg tablet strengths for once-daily oral dosing. For investors, the approval itself is a discrete, value-creating milestone because it enables commercialization activities, but the 8-K does not provide revenue expectations, pricing, distribution plans, or timing. The attached press release and presentation may offer additional color, and the company organized a conference call and webcast to discuss the milestone.

Regulatory / Industry Specialist

TL;DR: Approval establishes regulatory clearance for the indicated population and dosing; regulatory labeling and postapproval requirements are not detailed in the filing.

The 8-K states FDA approval of BRINSUPRI for non-cystic fibrosis bronchiectasis in adults and children 12 years and older with 10 mg and 25 mg oral once-daily tablets. This represents completion of the primary regulatory milestone required to commercialize the product in the U.S. However, the company did not disclose labeling specifics, postmarketing commitments, or other regulatory conditions in this filing. Investors should review the press release and presentation attached as Exhibits 99.1 and 99.2 and listen to the webcast for any additional regulatory or launch-related details.

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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): August 12, 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 (Zip Code)
(Address of principal executive offices)

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 August 12, 2025, Insmed Incorporated (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) has approved BRINSUPRI™ (brensocatib 25 mg and 10 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older. 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 Company will host a conference call to discuss the FDA approval on August 12, 2025, at 12:00 p.m., Eastern Time, and a live webcast of the call will be available through the investor relations section of the Company’s website. A copy of the slide presentation to be used by the Company during the conference call is attached hereto as Exhibit 99.2 to this Current Report on Form 8-K and incorporated herein by reference.

The information contained in this Item 7.01, including Exhibits 99.1 and 99.2 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 August 12, 2025, the Company announced that the FDA has approved BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children 12 years and older.

ITEM 9.01 — Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press release issued by Insmed Incorporated on August 12, 2025.
99.2		Insmed Incorporated August 12, 2025 BRINSUPRI FDA Approval Presentation.
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: August 12, 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?

The company announced that the FDA approved BRINSUPRI (brensocatib) for non-cystic fibrosis bronchiectasis in adults and children 12 years and older.

What dosing and formulation were approved for BRINSUPRI?

The approval covers oral once-daily tablets in 10 mg and 25 mg strengths.

When and how will Insmed discuss the FDA approval with investors?

Insmed will host a conference call on August 12, 2025 at 12:00 p.m. Eastern Time with a live webcast available through the company's investor relations website.

Where can I find the press release and presentation about the approval?

The press release is attached as Exhibit 99.1 and the slide presentation as Exhibit 99.2 to the Current Report.

Does the 8-K include financial projections or launch timing for BRINSUPRI?

No. The filing does not include any financial results, revenue guidance, or launch timing for BRINSUPRI.