Insmed (INSM) catalysts

Upcoming FDA decisions and readouts we track for Insmed, each with the filing that announced it.

Listed on — Nasdaq Catalysts tracked — 1 Rows last checked — 14 Sep 2026

FreeBioList has 1 catalyst on record for Insmed (INSM, listed on Nasdaq), all now decided. It concerns Brensocatib (BRINSUPRI) (Non-cystic fibrosis bronchiectasis (Japan)).

Decided and on record:

Brensocatib (BRINSUPRI), Regulatory milestone: Approved in Japan 24 August 2026.

Each outcome links to the filing or notice that reported it in the table below.

The row links to a company press release. It still needs confirming against the company's own filing. The methodology page explains each status.

Background reading: Why catalyst windows like "H2 2026" are vague, and how they narrow.

Ticker: INSM
Next catalyst: —
Type: —
Listed options: Yes

Company ▾	Drug ▾	Effect / indication	Next catalyst ▾	Phase / type ▾	Status ▾	Source	Options
Insmed INSM · Nasdaq	Brensocatib (BRINSUPRI)	Non-cystic fibrosis bronchiectasis (Japan)	H2 2026 secondary source	Regulatory milestone	Reported	Press release ↗	Yes
Notes — Company press release: Japan's MHLW approved BRINSUPRI (brensocatib) for non-cystic fibrosis bronchiectasis. No separate SEC 8-K was found for this foreign regulatory approval as of the check date. Outcome — Approved in Japan 24 August 2026 — Japan's MHLW approved BRINSUPRI (brensocatib) 25 mg tablet for non-cystic fibrosis bronchiectasis in patients 12 and older, based on the Phase 3 ASPEN data. Source: Press release, filed 24 Aug 2026 · verified 14 Sep 2026

Companies working on related conditions

4D Molecular Therapeutics (FDMT)Cystic fibrosis lung disease; Wet age-related macular degeneration
Arcturus Therapeutics (ARCT)Ornithine transcarbamylase deficiency; Cystic fibrosis (inhaled mRNA)