INSM · Company research

Insmed Incorporated

4 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

ApprovalINSMInsmedH2 2026

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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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
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MilestoneINSMInsmedH2 2026

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.

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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

MilestoneINSMInsmedH2 2026

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.

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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

MilestoneINSMInsmedH1 2027

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.

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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

Past catalysts

MilestoneINSMInsmedQ3 2026

INS1033 Phase 1 healthy-volunteer trial initiation, in Q3 2026 (Jul–Sep). A company milestone for Insmed (INS1033 for immunology & inflammation (undisclosed)): a step in the program rather than a decision or a data readout.

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Entry

INS1033 Phase 1 healthy-volunteer trial initiation · Company milestone

Drug

INS1033

For

immunology & inflammation (undisclosed)

Stage

Phase 1 · an early safety study in a small group of people

When

Q3 2026 · the company gave a window, not a day

Source note

Q2 2026 PR (Aug 6, 2026): IND for INS1033 cleared by FDA in July 2026; Phase 1 HV start planned 3Q26.

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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

Trial resultsINSMInsmedJul 16, 2026

Insmed reported results from its Phase 2 study of TPIP (treprostinil palmitil inhalation powder) for Pulmonary arterial hypertension on Jul 16, 2026. The study met its main goal.

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Entry

TPIP open-label extension: sustained 12-month benefit in PAH · Clinical trial results (readout / topline data)

Drug

TPIP (treprostinil palmitil inhalation powder)

For

Pulmonary arterial hypertension

Stage

Phase 2 · the stage that tests whether the drug actually works

When

Jul 16, 2026

Source note

Twelve-month open-label extension data showed sustained improvement across all secondary efficacy measures including REVEAL Lite 2.0 risk reduction, with placebo-crossover patients catching up to continued-TPIP patients by Month 12 and no new safety signals.

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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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsINSMInsmedApr 7, 2026

Insmed reported results from its Phase 2b study of Brensocatib (BRINSUPRI) for Hidradenitis suppurativa on Apr 7, 2026. The study missed its main goal.

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Entry

Phase 2b CEDAR failed; Insmed drops brensocatib in hidradenitis suppurativa · Clinical trial results (readout / topline data)

Drug

Brensocatib (BRINSUPRI)

For

Hidradenitis suppurativa

Stage

Phase 2b

When

Apr 7, 2026

Source note

Brensocatib missed both primary and secondary efficacy endpoints at 10 mg and 40 mg in moderate-to-severe hidradenitis suppurativa. Insmed discontinued the HS program outright; safety was consistent with prior studies.

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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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsINSMInsmedMar 23, 2026

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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Entry

Phase 3b ENCORE met primary and all key secondary endpoints in MAC lung disease · Clinical trial results (readout / topline data)

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

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsINSMInsmedMay 28, 2024

Insmed reported results from its Phase 3 study of brensocatib for Bronchiectasis on May 28, 2024. The linked source has what the numbers showed.

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Entry

ASPEN topline: brensocatib met primary endpoint · Clinical trial results (readout / topline data)

Drug

brensocatib

For

Bronchiectasis

Stage

Phase 3 · the last stage before a drug can be approved

When

May 28, 2024

Source note

First positive Phase 3 in bronchiectasis; both doses cut exacerbations.

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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

Things of Interest

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

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