INSMED Inc. Files 8-K Report

TL;DR

INSMED filed an 8-K, mostly standard stuff with exhibits.

AI Summary

On February 6, 2025, INSMED Inc. filed an 8-K report. The filing primarily concerns financial statements and exhibits, along with other events and a Regulation FD disclosure. No specific financial figures or new material events were detailed in the provided excerpt.

Why It Matters

This 8-K filing indicates INSMED Inc. is providing updates to the SEC, which could include important financial or operational information for investors.

Risk Assessment

Risk Level: low — The filing excerpt is a standard 8-K notification without specific material events or financial disclosures that would immediately impact risk.

Key Players & Entities

• INSMED Inc. (company) — Registrant
• February 6, 2025 (date) — Date of earliest event reported
• Virginia (jurisdiction) — State of incorporation
• 000-30739 (filing_number) — Commission File Number
• 54-1972729 (tax_id) — IRS Employer Identification No.
• 700 US Highway 202/206 (address) — Principal executive offices
• Bridgewater (city) — Principal executive offices
• NJ (state) — Principal executive offices
• 08807 (zip_code) — Principal executive offices
• (908) 977-9900 (phone_number) — Registrant's telephone number

FAQ

Key Financial Figures

• $0.01 — h registered Common Stock, par value $0.01 per share INSM Nasdaq Global Select

Filing Documents

• ef20043003_8k.htm (8-K) — 29KB
• ef20043003_ex99-1.htm (EX-99.1) — 22KB
• image0.jpg (GRAPHIC) — 18KB
• 0001140361-25-003266.txt ( ) — 215KB
• insm-20250206.xsd (EX-101.SCH) — 4KB
• insm-20250206_lab.xml (EX-101.LAB) — 21KB
• insm-20250206_pre.xml (EX-101.PRE) — 16KB
• ef20043003_8k_htm.xml (XML) — 4KB

01 — Other Events

ITEM 8.01 — Other Events. On February 6, 2025, Insmed Incorporated (the "Company") announced that the U.S. Food and Drug Administration (the "FDA") has accepted for review the Company's New Drug Application ("NDA") for brensocatib for patients with non-cystic fibrosis bronchiectasis. The FDA has 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.

01 — Regulation FD Disclosure

ITEM 7.01 — Regulation FD Disclosure. On February 6, 2025, the Company issued a press release announcing that the FDA has accepted for review 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.

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, dated February 6, 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: February 6, 2025 INSMED INCORPORATED By: /s/ Michael A. Smith Name: Michael A. Smith Title: Chief Legal Officer and Corporate Secretary