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Insmed (INSM) FDA Events

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FDA Events for Insmed (INSM)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Insmed (INSM). Over the past two years, Insmed has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ARIKAYCE®, Brensocatib, and Treprostinil. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Insmed's Drugs in FDA Review

ARIKAYCE® - FDA Regulatory Timeline and Events

ARIKAYCE® is a drug developed by Insmed for the following indication: IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Brensocatib - FDA Regulatory Timeline and Events

Brensocatib is a drug developed by Insmed for the following indication: In Patients with Bronchiectasis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Treprostinil Palmitil Inhalation Powder (TPIP) - FDA Regulatory Timeline and Events

Treprostinil Palmitil Inhalation Powder (TPIP) is a drug developed by Insmed for the following indication: Pulmonary arterial hypertension (PAH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Insmed FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Insmed (INSM) has reported FDA regulatory activity for the following drugs: Brensocatib, ARIKAYCE® and Treprostinil Palmitil Inhalation Powder (TPIP).

The most recent FDA-related event for Insmed occurred on June 10, 2025, involving Treprostinil Palmitil Inhalation Powder (TPIP). The update was categorized as "Top-line results," with the company reporting: "Insmed Incorporated announced positive topline results from its randomized, double-blind, placebo-controlled Phase 2b study evaluating the efficacy and safety of treprostinil palmitil inhalation powder (TPIP), administered once daily in patients with pulmonary arterial hypertension (PAH, World Health Organization Group 1)."

Current therapies from Insmed in review with the FDA target conditions such as:

  • In Patients with Bronchiectasis - Brensocatib
  • IN PATIENTS WITH NTM LUNG DISEASE CAUSED BY MAC - ARIKAYCE®
  • Pulmonary arterial hypertension (PAH) - Treprostinil Palmitil Inhalation Powder (TPIP)

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:INSM) was last updated on 7/11/2025 by MarketBeat.com Staff
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