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Insmed 8-K Report, Regulation FD Disclosure (Aug 12, 2025)

Reports
Regulation FD·Other Events·Exhibits & Filings
Filing Date
Filed August 12, 2025
Period End
August 12, 2025
Security
INSM
In the record · 2016–202610-K1110-Q338-K134

INSM filed 11 annual reports (10-K), 33 quarterly reports (10-Q) and 134 current reports (8-K) between 2016 and 2026.

  1. Material agreement8-K · Jan ’18Jan ’18
  2. Leadership change8-K · May ’20May ’20
  3. Material agreement8-K · Oct ’22Oct ’22
  4. Leadership change8-K · Oct ’26Oct ’26

01—Abstract

Summary

Summary of the 8-K filed August 12, 2025. Cited figures are marked; the original filing is the authoritative source.

Insmed Incorporated (Nasdaq: INSM) announced on August 12, 2025 that the U.S. Food and Drug Administration has approved BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older.

The company describes it as the first and only FDA-approved treatment for NCFB and a first-in-class DPP1 inhibitor. The filing states that BRINSUPRI is now available by prescription through a specialty pharmacy network, and the company's presentation projects peak sales above $5 billiona in the NCFB indication only, with a gross-to-net assumption of approximately 25% to 35%. The approval rests on the Phase 3 ASPEN and Phase 2 WILLOW studies, both published in the New England Journal of Medicine.

In ASPEN, patients taking BRINSUPRI 10 mg or 25 mg had a 21.1%b and 19.4% reduction in annual rate of exacerbations, respectively, versus placebo. The 25 mg dose also showed statistically significant less decline in FEV1 at week 52. Safety highlights in the label include dermatologic adverse reactions, gingival and periodontal adverse reactions, and a warning to avoid live attenuated vaccines.

The company also noted that applications are under review with the EMA and MHRA, that it plans to file in Japan in 2025, and that commercial launches outside the U.S. are anticipated in 2026, pending approval. The company will host a conference call on August 12, 2025 at 12:00 p.m.

Eastern Time to discuss the approval. The presentation states that the company expects its sales force to begin engaging U.S. pulmonologists immediately, and it cites approximately 500,000 U.S. patients diagnosed with NCFB as the potential addressable population.

02—Key points

Key Highlights

  1. FDA approved BRINSUPRI (brensocatib 10 mg and 25 mg tablets), an oral, once-daily treatment for NCFB in adults and children 12 years and older.
  2. The company describes BRINSUPRI as the first and only FDA-approved treatment for NCFB and a first-in-class DPP1 inhibitor.
  3. In the Phase 3 ASPEN study, annual rate of exacerbations was reduced by 21.1% (10 mg) and 19.4% (25 mg) versus placebo.
  4. The 25 mg dose showed statistically significant less decline in FEV1 at week 52 compared to placebo.
  5. BRINSUPRI is now available by prescription through a comprehensive specialty pharmacy network in the U.S.
  6. The presentation estimates peak sales above $5 billion in the NCFB indication only, with a 25% to 35% gross-to-net assumption.
  7. Label warnings cover dermatologic and gingival/periodontal adverse reactions, and live attenuated vaccines should be avoided; EMA and MHRA applications are under review, with commercial launches anticipated in 2026 outside the U.S.

03—Questions

Frequently Asked Questions

  1. What did the FDA approve?

    The FDA 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.

  2. What clinical data supported the approval?

    The approval is based on the Phase 3 ASPEN study and the Phase 2 WILLOW study, both published in the New England Journal of Medicine. In ASPEN, exacerbation rates fell 21.1% (10 mg) and 19.4% (25 mg) versus placebo.

  3. What are the main safety concerns in the label?

    The label includes warnings for dermatologic adverse reactions (rash, dry skin, hyperkeratosis) and gingival and periodontal adverse reactions, and advises avoiding live attenuated vaccines during treatment. The most common adverse reactions at or above 2% in ASPEN included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension.

  4. Is BRINSUPRI commercially available and what are the sales expectations?

    BRINSUPRI is now available in the U.S. by prescription through a specialty pharmacy network. The presentation cites a peak sales estimate above $5 billion in the NCFB indication only, and says the company expects to provide sales guidance later.

  5. What are the international plans?

    Applications are under review with the EMA and MHRA, and the company plans to file in Japan in 2025. Commercial launches outside the U.S. are anticipated in 2026, pending approval in each territory.

04—Continue

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