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Insmed’s Brensocatib Receives FDA Priority Review

Story Highlights
  • Insmed announced FDA’s decision not to hold an advisory meeting for brensocatib.
  • Brensocatib could be the first approved treatment for bronchiectasis, with FDA priority review set for August 2025.
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Insmed’s Brensocatib Receives FDA Priority Review

Insmed ( (INSM) ) has issued an update.

On February 24, 2025, Insmed announced that the FDA does not plan to hold an advisory committee meeting for their New Drug Application (NDA) of brensocatib, a treatment for non-cystic fibrosis bronchiectasis. The FDA has granted priority review to the NDA, with a target action date set for August 12, 2025. Brensocatib, based on data from the ASPEN study, could become the first approved treatment for bronchiectasis and represents a new class of medicines targeting neutrophil-mediated diseases.

More about Insmed

Insmed Incorporated is a global biopharmaceutical company focused on delivering first- and best-in-class therapies for serious diseases. The company is advancing a portfolio of approved and investigational medicines, particularly in pulmonary and inflammatory conditions, and is recognized as a leading employer in the biopharmaceutical industry.

YTD Price Performance: 15.88%

Average Trading Volume: 1,831,117

Technical Sentiment Consensus Rating: Sell

Current Market Cap: $14.67B

For an in-depth examination of INSM stock, go to TipRanks’ Stock Analysis page.

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