BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//ORION Biotech Catalyst Calendar//company//EN
CALSCALE:GREGORIAN
X-WR-CALNAME:ORION — INSM stated timing
X-WR-CALDESC:Exact dates INSM stated in SEC filings\, quoted as written\, w
 ith SEC links. No forecasts.
REFRESH-INTERVAL;VALUE=DURATION:PT12H
X-PUBLISHED-TTL:PT12H
BEGIN:VEVENT
UID:orion-event-FDA20261030-INSM-FDA-DECISION@orionbiotechai.com
SEQUENCE:1
DTSTAMP:20261029T000000Z
LAST-MODIFIED:20261029T000000Z
DTSTART;VALUE=DATE:20270128
DTEND;VALUE=DATE:20270129
SUMMARY:INSM ARIKAYCE (amikacin liposome inhalation suspension): FDA decisi
 on\, “January 28\, 2027”
DESCRIPTION:INSMED Inc (INSM)\, ARIKAYCE (amikacin liposome inhalation susp
 ension): PDUFA target action date.\nCompany wording\, as written: “In Se
 ptember 2026\, the U.S. Food and Drug Administration (FDA) accepted Insmed
 ’s Supplemental New Drug Application (sNDA) for review of ARIKAYCE for t
 he treatment of Mycobacterium avium complex (MAC) lung disease as part of 
 a combination antibacterial drug regimen. The FDA granted Priority Review 
 to the sNDA and set a target action date of January 28\, 2027\, under the 
 Prescription Drug User Fee Act (PDUFA).”\nStated period: “January 28\,
  2027”.\nFiled 2026-10-29\, SEC Form 8-K\, EX-99.1.\nSEC filing: https:/
 /www.sec.gov/Archives/edgar/data/1104506/000114036126041097/ef20084500_ex9
 9-1.htm\nORION page: https://www.orionbiotechai.com/company/INSM?src=ics\n
 ORION records what the company wrote. It is not a forecast.
URL:https://www.orionbiotechai.com/company/INSM?src=ics
TRANSP:TRANSPARENT
END:VEVENT
END:VCALENDAR