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Home › PDUFA Calendar › INSM

INSMED Inc (INSM) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
no upcoming catalyst on file · 1 past FDA decision

FDA decision history (1)

Aug 12, 2025✓ ApprovedFDA decision

Clinical readouts (1)

2026-12Treprostinil Palmitil Inhalation Powder
Full PDUFA calendar →All FDA decisions →Phase readouts →
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This page aggregates INSM's FDA catalysts from pdufa.bio's own calendar and decision archive. Each item links to its source page. Facts and dates only; verify against primary FDA / SEC / company filings.

INSM run-up, measured

Computed from this stock's own daily closing prices, on the same T-120 basis as the run-up study: the baseline is the close 120 trading sessions before the eve of the decision. These are measurements of what already happened, not predictions.

INSM's past FDA decisions (n=1)
DecisionOutcomeT-120 to eveT-120 to peak
2025-08-12APPROVAL+38.8%+38.8%
With only one decision on record, no median is shown: an average of 1 event would not be a meaningful statistic. The individual figures above are exact. For a statistical base see the run-up study, built on 1,839 decisions.

Common questions

When is the next FDA decision or readout for INSMED Inc (INSM)?

December 2026. The next catalyst for INSMED Inc is Treprostinil Palmitil Inhalation Powder (readout). That date is known to the month only. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.

Has INSMED Inc (INSM) had an FDA decision before?

Yes, 1 in our archive: 1 approval(s) and 0 Complete Response Letter(s). The most recent was on August 12, 2025 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How do stocks like INSM move into an FDA decision?

We have no measured history for INSM itself. Across the whole study of 1,839 FDA decisions, the median stock rose 17.7% at its best point in the 120 trading days before the decision, but was only 2.0% higher the day before it. Most of the move happened before the answer arrived and was largely given back.

Where does this INSM data come from?

FDA publications, company filings with the SEC, company press releases and ClinicalTrials.gov, with share prices measured from daily closing data. Every date and outcome links the document it came from. Where an outcome was inferred from the price reaction rather than read from a filing, the page says so on its face.