INSMED Inc INSM
INSMED Inc (Nasdaq: INSM) is a respiratory drug developer. Its lead program, BRINSUPRI (brensocatib), is in Phase 3 for non-cystic fibrosis bronchiectasis (NCFB). Its next catalyst on record is ARIKAYCE: US sNDA for MAC lung disease - priority review target action date (January 28, 2027).
Upcoming catalysts
- January 28, 2027ARIKAYCE — US sNDA for MAC lung disease - priority review target action date
In September 2026, our US supplemental new drug application (sNDA) for ARIKAYCE in patients with MAC lung disease was accepted and granted priority review by the FDA as part of a combination antibacterial drug regimen, with a target action date of January 28, 2027.
Next further out: INS1033 — Insmed expects to advance INS1033, a DPP1 candidate, to Phase 2 study in rheumatoid arthritis in 2027 following positive Phase 1 data. (2027). 6 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 (NCFB) in patients ≥12 years | small molecule | Approved |
| ARIKAYCE (amikacin liposome inhalation suspension) | MAC lung disease | small molecule | Approved |
| TPIP (treprostinil palmitil) | PH-ILD, PAH, PPF, IPF | small molecule | Phase 3 |
| INS1148 | IPF, PPF, and other fibrotic diseases | antibody | Phase 2 |
| INS1201 | Duchenne muscular dystrophy (DMD) | gene therapy | Phase 1 |
| INS1202 | amyotrophic lateral sclerosis (ALS) | gene therapy | Phase 1 |
Recent results and decisions
- Oct 29, 2026accepted FDA accepted sNDA for ARIKAYCE in MAC lung disease with PDUFA target action date of January 28, 2027.
sNDA granted priority review by FDA, with PDUFA target action date of January 28, 2027
Filing - Oct 29, 2026completed enrollment Phase 1 study of INS1202 in 12 pediatric DMD patients fully enrolled, with initial data expected in 2027.
Fully enrolled Phase 1 study of 12 pediatric DMD patients Expect to share initial data in 2027
Filing - Oct 29, 2026started Phase 1 study of INS1201 in ALS patients is actively enrolling with initial data expected in 2027, Cohort 1 fully enrolled.
Phase 1 study actively enrolling sporadic and SOD1 ALS patients Cohort 1 fully enrolled (all sporadic patients) Expect to share initial data in 2027
Filing
15 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.