ARIKAYCE (amikacin liposome inhalation suspension) is an INSMED Inc program in MAC lung disease, as part of a combination antibacterial drug regimen. Its PDUFA date is Jan 28, 2027, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: MAC lung disease, as part of a combination antibacterial drug regimen. Sponsor: INSMED Inc (INSM). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 8,796,111 | $937.8 million | filed August 14, 2026 |
| RTW Investments | 4,842,880 | $516.3 million | filed August 14, 2026 |
| Cormorant Asset Management | 75,000 | $8.0 million | filed August 14, 2026 |
| Redmile Group | 51,234 | $5.5 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
ARIKAYCE (amikacin liposome inhalation suspension)'s PDUFA date is Jan 28, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for ARIKAYCE (amikacin liposome inhalation suspension) is in our archive yet.
In our records ARIKAYCE (amikacin liposome inhalation suspension) is under review or in development for MAC lung disease, as part of a combination antibacterial drug regimen.
INSMED Inc (INSM).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.