Japan regulatory decision on brensocatib in bronchiectasis
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.
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- Company
- Insmed Incorporated INSM
- Drug
- BRINSUPRI (brensocatib)
- For
- Non-cystic fibrosis bronchiectasis
- Stage
- Registration (Japan)
- When
- H2 2026 · the company gave a window, not a day; the calendar never invents one
- 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
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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