Insmed Incorporated INSM
Insmed Incorporated (Nasdaq: INSM) is a respiratory drug developer. Its lead program, BRINSUPRI (brensocatib) / ARIKAYCE, is in Phase 3 for non-cystic fibrosis bronchiectasis; MAC lung disease. Its next catalyst on record is TPIP: Initiate Phase 3 study in progressive pulmonary fibrosis (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: TPIP — Initiate Phase 3 study in progressive pulmonary fibrosis (H2 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| BRINSUPRI (brensocatib) | non-cystic fibrosis bronchiectasis (FDA approved Aug 2025) | small molecule | Approved |
| ARIKAYCE | MAC lung disease (accelerated approval Sept 2018; sNDA for newly diagnosed patients submitted July 2026) | small molecule | Approved |
| TPIP (treprostinil palmitil) | PH-ILD (Phase 3 PALM-ILD) and PAH (Phase 3 PALM-PAH) | small molecule | Phase 3 |
| brensocatib | hidradenitis suppurativa | small molecule | Phase 2 |
| INS1148 | progressive pulmonary fibrosis / idiopathic pulmonary fibrosis | antibody | Phase 2 |
| INS1201 | Duchenne muscular dystrophy | gene therapy | Phase 1 |
| INS1202 | amyotrophic lateral sclerosis | gene therapy | Phase 1 |
Recent results and decisions
- Aug 6, 2026submitted Insmed reports it has filed an sNDA with FDA for ARIKAYCE in newly diagnosed MAC lung disease patients.
Filed sNDA with FDA for newly diagnosed MACLD patients
Filing - Jul 16, 2026positive 12-month open-label extension data positive: 6MWD +55.7 m (continued) and +54.1 m (placebo-crossed), NT-proBNP down ~60%, no new safety signals up to 1,280 µg.
today announced positive 12-Month data from the ongoing open-label extension (OLE) study evaluating treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension
Filing - May 7, 2026started Phase 3 PALM-PAH study of TPIP in PAH initiated in April 2026.
Phase 3 PALM-PAH Study of TPIP in Patients with PAH Initiated in April 2026
Filing
10 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 respiratory companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.