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Home › PDUFA Calendar › PTGX

Protagonist Therapeutics Inc. (PTGX) FDA catalysts & readout calendar

Updated ·next FDA decision on the calendar
Protagonist Therapeutics Inc. · 1 upcoming · 1 past FDA decision

Upcoming FDA catalysts

PTGX · Sep 30, 2026Rusfertide - (REVIVE): Polycythemia vera

FDA decision history (1)

Mar 18, 2026✓ ApprovedFDA decision
Full PDUFA calendar →All FDA decisions →Phase readouts →
See the full 2026 PDUFA calendar →

This page aggregates PTGX'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.

PTGX 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.

Run-up so far, this catalyst
Since its T-120 baseline on 2026-04-09 ($104.08), PTGX is +38.7% to $144.33 at the close on 2026-08-28. The highest close since that baseline is +52.4% above it.
99 of 120 sessions elapsed, 21 to go. Cohort context: across 1,839 past decisions the median peak from T-120 was 17.7% and the median move to the day before the decision was 2.0%.
PTGX's past FDA decisions (n=1)
DecisionOutcomeT-120 to eveT-120 to peak
2026-03-18APPROVAL+49.4%+49.4%
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 Protagonist Therapeutics Inc. (PTGX)?

September 30, 2026. The next catalyst for Protagonist Therapeutics Inc. is Rusfertide - (REVIVE) (PDUFA). That date is a confirmed date. Dates are taken from FDA notices, company filings or ClinicalTrials.gov, and we do not publish a specific day when the source only gives a month or a quarter.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 Protagonist Therapeutics Inc. (PTGX) had an FDA decision before?

Yes, 1 in our archive: 1 approval(s) and 0 Complete Response Letter(s). The most recent was on March 18, 2026 and was an approval. Each one has its own page with the source document and the share-price reaction we measured.

How has PTGX stock moved into its FDA decisions?

Measured from this company's own daily closing prices: Since its T-120 baseline on 2026-04-09 ($104.08), PTGX is +38.7% to $144.33 at the close on 2026-08-28. The highest close since that baseline is +52.4% above it. These are historical measurements of what already happened, not forecasts, and we publish no price targets or probability of approval.

Where does this PTGX 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.