Primary-source record

Decision-gradeFDA approval

Insmed: FDA approves BRINSUPRI (brensocatib) for NCFB

FDA approved the NDA for brensocatib, making BRINSUPRI the first and only approved treatment for non-cystic fibrosis bronchiectasis. The product was subsequently launched in the U.S. and generated $28.1 million in Q3 2025 revenue. Positive CHMP opinion was also adopted in the EU with submissions accepted in the UK and Japan.

Key facts

Filed
Oct 30, 2025, 11:00 AM
Event
FDA approval
Direction
Positive
Source
SEC 8-K
Confidence
Sourced

Source excerpt

EX-99.1 2 ef20057768_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Insmed Reports Third-Quarter 2025 Financial Results and Provides Business Update — BRINSUPRI ™ (brensocatib ) Approved by FDA as First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis; Positive CHMP Opinion Adopted in the European Union and Application Accepted in Japan— — BRINSUPRI Total Revenue of $28.1 Million for the Third Quarter of 2025— —ARIKAYCE ® (amikacin liposome inhalation suspension) Total Revenue of $114.3 Million for the Third Quarter of 2025, Reflecting 22% Growth Over the Third Quarter of 2024— —Company Raises 2025 Global ARIKAYCE Revenue Guidance Range to $420 Million to $430 Million, Reflecting Double-Digit Growth Compared to 2024— —Topline Data Readout Anticipated for Phase 2b BiRCh Study of Brensocatib in Patients with CRSsNP by Early January 2026— —Phase 2b CEDAR Study of Brensocatib in Patients with HS Now Fully Enrolled, with Topline Data Anticipated in the First Half of 2026— —PALM-ILD Phase 3 Study of TPIP for PH-ILD Expected to Initiate in the Fourth Quarter of 2025; Additional Phase 3 Studies Planned for PAH, PPF, and IPF in 2026— BRIDGEWATER, N.J., October 30, 2025 / PRNewswire / -- Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today reported financial results for the third quarter ended September 30, 2025 and provided a

SEC 8-K

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Insmed: FDA approves BRINSUPRI (brensocatib) for NCFB | SimianX AI