Insmed Inc. Files 8-K on Dec 17, 2025

Ticker: INSM · Form: 8-K · Filed: 2025-12-17T00:00:00.000Z

Sentiment: neutral

Topics: 8-K, disclosure, corporate-filing

TL;DR

INSMOD filed an 8-K on 12/17/25 - check for material updates.

AI Summary

Insmed Incorporated filed an 8-K on December 17, 2025, reporting on events including Regulation FD disclosures, other events, and financial statements. The company, incorporated in Virginia with its principal executive offices in Bridgewater, New Jersey, operates in the Pharmaceutical Preparations industry.

Why It Matters

This filing provides an official record of Insmed's corporate activities and disclosures made on December 17, 2025, which could include material information for investors.

Risk Assessment

Risk Level: low — This is a routine 8-K filing that typically reports on corporate events and disclosures without immediate, significant financial impact.

Key Numbers

Key Players & Entities

FAQ

What specific events are detailed in the Regulation FD Disclosure section of this 8-K?

The filing indicates a Regulation FD Disclosure, but the specific details of the disclosure are not provided in the provided text.

Are there any financial statements included with this 8-K filing?

Yes, the filing explicitly lists 'Financial Statements and Exhibits' as an item information category.

What is Insmed Incorporated's Standard Industrial Classification (SIC) code?

Insmed Incorporated's SIC code is 2834, which corresponds to Pharmaceutical Preparations.

When was Insmed Incorporated incorporated?

Insmed Incorporated was incorporated in Virginia.

What is the primary business address for Insmed Incorporated?

The primary business address for Insmed Incorporated is 700 US Highway 202/206, Bridgewater, New Jersey 08807.

Filing Stats: 1,399 words · 6 min read · ~5 pages · Grade level 14.9 · Accepted 2025-12-17 16:02:43

Key Financial Figures

Filing Documents

01 — Regulation FD Disclosure

ITEM 7.01 — Regulation FD Disclosure. On December 17, 2025 , Insmed Incorporated (the "Company") issued a press release announcing topline efficacy and safety results from the Phase 2b BiRCh study of brensocatib in patients with chronic rhinosinusitis without nasal polyps ("CRSsNP") and the acquisition of INS1148, an investigational monoclonal antibody that the Company plans to develop for respiratory and immunological and inflammatory diseases with high unmet need. 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.

01 — Other Events

ITEM 8.01 — Other Events. On December 17, 2025 , the Company issued a press release announcing topline efficacy and safety results from the Phase 2b BiRCh study of brensocatib for patients with CRSsNP. The BiRCh study was a randomized, double-blind, parallel-group, placebo-controlled, multicenter study to evaluate the efficacy and safety of brensocatib compared to placebo. The study was conducted at 104 sites globally, and a total of 288 patients were randomized 1:1:1 to receive either brensocatib 10 mg (n=99), brensocatib 40 mg (n=94), or placebo (n=95) daily for 24 weeks in addition to daily treatment with mometasone furoate nasal spray background therapy. The primary endpoint was change from baseline in the 28-day average of daily Sinus Total Symptom Score ("sTSS") at Week 24. Results from each treatment arm for the primary endpoint of change from baseline to the 28-day average of daily sTSS at Week 24 were as follows: placebo least squares ("LS") mean was -2.44; the 10 mg brensocatib treatment arm LS mean was -2.21; and the 40 mg brensocatib treatment arm LS mean was -2.33. Brensocatib was observed to be well tolerated, with no new safety signals identified. The percentage of treatment-emergent adverse events ("TEAEs") were: Brensocatib 10 mg Once Daily (N=99) Brensocatib 40 mg Once Daily (N=93) Placebo (N=95) Any TEAE, n(%) 63 (63.6) 65 (69.9) 62 (65.3) Serious TEAE, n(%) 2 (2.0) 3 (3.2) 2 (2.1) Severe TEAE, n(%) 0 0 3 (3.2) The Company has discontinued its development program of brensocatib in CRSsNP and intends to present these data at a future congress.

Forward-Looking Statements

Forward-Looking Statements The forward-looking statements in this Current Report on Form 8-K are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: the risk that the full data set from the BiRCh study will not be consistent with the topline results of the BiRCh study; failure to successfully conduct future clinical trials, such as the Company's planned Phase 2 studies of INS1148 in interstitial lung disease and moderate-to-severe asthma, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; development of unexpected safety or efficacy concerns related to its product candidates; failure of third parties on which the Company is dependent to manufacture sufficient quantities of drug product for clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company; failure to obtain regulatory approval for the Company's product candidates; inaccuracies in the Company's estimates of the size of the potential markets for its product candidates or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates, if the Company's product candidates are approved; inability of the Company or the Company's third-party manufacturers to comply with regulatory requirements related to the Company

01 – Financial Statements and Exhibits

ITEM 9.01 – Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press release issued by Insmed Incorporated on December 17, 2025. 104 Cover Page Interactive Date File (embedded within the Inline XBRL document).

SIGNATURES

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: December 17, 2025 INSMED INCORPORATED By: /s/ Michael A. Smith Name: Michael A. Smith Title: Chief Legal Officer and Corporate Secretary

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