Phase 3b ENCORE met primary and all key secondary endpoints in MAC lung disease
Insmed reported results from its Phase 3b study of ARIKAYCE (amikacin liposome inhalation suspension) for Mycobacterium avium complex lung disease on Mar 23, 2026. The study met its main goal.
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- Company
- Insmed Incorporated INSM
- Drug
- ARIKAYCE (amikacin liposome inhalation suspension)
- For
- Mycobacterium avium complex lung disease
- Stage
- Phase 3b
- When
- Mar 23, 2026
- Source note
- ARIKAYCE plus azithromycin/ethambutol beat placebo plus multidrug therapy on the primary respiratory symptom score endpoint and all multiplicity-controlled culture conversion secondaries in newly diagnosed MAC patients. Insmed planned an sNDA in 2H 2026.
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- Source: sec.gov ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- INSM headlines on this site
Insmed expects Japanese regulators to decide on BRINSUPRI (brensocatib) for Non-cystic fibrosis bronchiectasis in the second half of 2026 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- Japan regulatory decision on brensocatib in bronchiectasis · Regulatory approval
- Drug
- BRINSUPRI (brensocatib)
- For
- Non-cystic fibrosis bronchiectasis
- Stage
- Registration (Japan)
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 update (Aug 6, 2026): company continues to anticipate a Japan regulatory decision for brensocatib in NCFB in the second half of 2026.
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- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- INSM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
TPIP Phase 3 initiation in progressive pulmonary fibrosis, expected in the second half of 2026 (no exact date yet). A company milestone for Insmed (TPIP (treprostinil palmitil inhalation powder) for Progressive pulmonary fibrosis): a step in the program rather than a decision or a data readout.
More details
- Entry
- TPIP Phase 3 initiation in progressive pulmonary fibrosis · Company milestone
- Drug
- TPIP (treprostinil palmitil inhalation powder)
- For
- Progressive pulmonary fibrosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 update: anticipate initiating a Phase 3 study of TPIP in PPF in the second half of 2026 (PALM-ILD and PALM-PAH Phase 3s already enrolling).
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- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- INSM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
ARIKAYCE ENCORE data review with Japan PMDA for label expansion in 2H 2026, expected in the second half of 2026 (no exact date yet). A company milestone for Insmed (ARIKAYCE (amikacin liposome inhalation suspension) for newly diagnosed MAC lung disease): a step in the program rather than a decision or a data readout.
More details
- Entry
- ARIKAYCE ENCORE data review with Japan PMDA for label expansion in 2H 2026 · Company milestone
- Drug
- ARIKAYCE (amikacin liposome inhalation suspension)
- For
- newly diagnosed MAC lung disease
- Stage
- Regulatory (Japan)
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Q2 2026 PR (Aug 6, 2026); US sNDA for newly diagnosed MAC already submitted in July 2026 (no PDUFA disclosed yet).
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- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- INSM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
TPIP Phase 3 initiation in idiopathic pulmonary fibrosis, expected in the first half of 2027 (no exact date yet). A company milestone for Insmed (TPIP (treprostinil palmitil inhalation powder) for Idiopathic pulmonary fibrosis): a step in the program rather than a decision or a data readout.
More details
- Entry
- TPIP Phase 3 initiation in idiopathic pulmonary fibrosis · Company milestone
- Drug
- TPIP (treprostinil palmitil inhalation powder)
- For
- Idiopathic pulmonary fibrosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Q2 2026 update: Phase 3 study of TPIP in IPF anticipated to initiate in the first half of 2027. Separately, ARIKAYCE sNDA for newly diagnosed MAC lung disease was submitted July 2026; PDUFA date not yet announced.
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- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- INSM headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page