INSMED Inc
2 products tracked · names used in filings: INSMED Inc, Insmed Limited, Insmed Europe Ltd
Upcoming milestones
INSMED Inc: PDUFA target action date
INSMED Inc (INSM); "$75.5M +2% Int’l $48.9M +21% Worldwide $124.4M +9% sNDA granted priority review by FDA, with PDUFA target action date of January 28, 2027 Intend to submit data to PMDA in Q4:26 to support potential Japan label expansion Expect to launch under expanded all MACLD label in the U.S."; filed 2026-10-29 · source
Recent milestones
Brensocatib: PDUFA target action date (bronchiectasis)
INSMED Inc (INSM); NDA; status: set; "…ides Business Update —ARIKAYCE ® (amikacin liposome inhalation suspension) Total Revenue of $107.4 Million for the Second Quarter of 2025, Reflecting 19% Growth Over the Second Quarter of 2024— —NDA for Brensocatib in Patients with Bronchiectasis Remains on Track, with a PDUFA Target Action Date of August 12,…"; filed 2025-08-07 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇪🇺 | Arikayce amikacin sulfate | Application withdrawn | |
| 🇪🇺 | Iplex mecasermin rinfabate | Application withdrawn |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.