Back to News
Market Impact: 0.3
Insmed's ARIKAYCE SNDA Gets FDA Priority Review; PDUFA Set For Jan 2027
Source: Nasdaq
Healthcare & BiotechRegulation & Legislation
Insmed said the FDA accepted its supplemental New Drug Application for ARIKAYCE, an amikacin liposome inhalation suspension, for review in Mycobacterium avium complex (MAC) lung disease. The acceptance advances a potential label-expansion pathway for the therapy, though no approval decision or review timeline was disclosed.
AllMind Terminal
AI-powered research, real-time alerts, and portfolio analytics for institutional investors.
Request TrialMarket Sentiment
Overall Sentiment
mildly positive
Sentiment Score
0.35
Ticker Sentiment
INSM0.65
More News
- Why is Insmed stock climbing today?
- FDA Grants Priority Review to Insmed's sNDA for ARIKAYCE® (amikacin liposome inhalation suspension) for Treatment of MAC Lung Disease With PDUFA Target Action Date Set for January 28, 2027
- Paramount agrees invest $1.5 billion in domestic movies and create a board for editorial independence at CNN, CBS as part of deal for Warner Bros.
- Paramount and state AGs will settle lawsuit, allowing Warner Bros. merger to proceed, reports say
- Paramount Set to Settle Lawsuits, Clearing Way for Warner Bros. Deal
- Paramount settles with US states in step towards merger with Warner Bros