INSMActive

Will Insmed begin PALM-PAH Phase III enrollment by end of H1 2026?

Resolves July 15, 2026(97d)

IG: 0.48

Current Prediction

55%

Likely Yes

Model Agreement97%

Predictions9 runs

Last UpdatedApril 8, 2026

Prediction Distribution

0%25%50%75%100%

opus

sonnet

haiku

Range: 50% – 60%Aggregate: 55%

Individual Predictions(9 runs)

opusRun 1

60%

Management explicitly guided H1 2026 enrollment start. Insmed has a track record of meeting pipeline milestones (BRINSUPRI approved on schedule). The company's clinical operations team is experienced. However, PAH trial site activation requires specialized centers, and only ~3 months remain in H1 2026. Companies with recent Phase III success have 70-75% on-time initiation rates, which is the relevant base rate.

Management explicitly guided H1 2026Strong track record of meeting milestonesOnly ~3 months remain — tight timeline

opusRun 2

55%

The 3-month remaining window is the key concern. Even with management guidance, Phase III trials in specialized indications like PAH frequently experience 1-2 quarter delays due to site activation, IRB approvals, and clinical supply manufacturing. The dry powder inhaler formulation may require specialized manufacturing that could create supply timing issues. Discounting the base rate for the tight remaining timeline.

3-month window is tight for Phase III initiationPAH requires specialized trial sitesDPI manufacturing may create supply timing issues

opusRun 3

58%

Insmed likely already has significant site activation work underway given the guidance. The 'first patient enrolled' threshold is a lower bar than 'fully enrolled' — it only requires one site to be active. For well-prepared programs, first patient enrollment can happen within weeks of site activation. Insmed's rare disease expertise and PAH being a well-characterized disease with established trial infrastructure support timely initiation.

First patient enrolled is lower bar than full enrollmentSite activation work likely already underwayPAH has established trial infrastructure

sonnetRun 1

55%

Base rate for Phase III initiation within guided timeline is 60-70% in rare disease. The tight remaining timeline (3 months) warrants some discount but management would not maintain H1 2026 guidance at this date if they expected a miss. Probability modestly above coin-flip.

Base rate 60-70% for on-time initiationManagement maintaining guidance at this late date is positiveTight timeline warrants some discount

sonnetRun 2

50%

The competing priorities of BRINSUPRI launch execution, ENCORE readout, and PALM-PAH initiation create organizational bandwidth constraints. Insmed is managing three major programs simultaneously. The BRINSUPRI launch absorbs significant management attention and commercial resources. While clinical operations are separate, C-suite bandwidth is finite.

Three major programs competing for bandwidthBRINSUPRI launch absorbs management attentionC-suite bandwidth constraints are real

sonnetRun 3

53%

Balancing management guidance, track record, and timeline concerns yields a probability modestly above 50%. The first-patient-enrolled threshold helps (lower bar), but PAH site activation is genuinely complex. The April 2026 date means we're already ~1 month into the remaining window.

First-patient-enrolled is achievable lower barPAH site activation is complexAlready 1 month into remaining window

haikuRun 1

57%

Management guidance and track record favor on-time initiation. The first-patient-enrolled threshold is achievable if site work is already underway. Probability modestly above coin-flip.

Management guidance supports H1 2026First-patient-enrolled is lower barSite work likely already underway

haikuRun 2

52%

Tight timeline with 3 months remaining and specialized PAH site requirements create meaningful risk. Base rate of 60-70% discounted for timeline and bandwidth constraints. Slightly above coin-flip.

3 months remaining is tightPAH requires specialized sitesBase rate discounted for constraints

haikuRun 3

55%

Insmed's execution track record and explicit guidance are the strongest positive signals. The tight timeline is the main risk. Net assessment slightly favors on-time enrollment.

Execution track record is strong positiveExplicit H1 2026 guidance maintainedTight timeline is primary risk

Resolution Criteria

Resolves YES if Insmed announces PALM-PAH Phase III first patient enrollment by June 30, 2026. Resolves NO if enrollment has not begun by that date.

Resolution Source

Insmed press release, ClinicalTrials.gov, or SEC filing

Source Trigger

TPIP Phase III enrollment — PALM-PAH trial start in H1 2026. This is the next-generation pipeline catalyst.

moat-mapperCOMPETITIVE_POSITIONMEDIUM

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