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PTGX PDUFA Date: Rusfertide

Page updated ·next FDA decision on the calendar ·Data as of Oct 11, 2026 9:31 PM ET
✓ Approved · the FDA decided this application on August 28, 2026. Decision page with the source and measured reaction.
FDA decision Approved August 28, 2026 · Protagonist Therapeutics Inc. · Polycythemia vera
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The story

Rusfertide was approved by the FDA on August 28, 2026 to treat Polycythemia vera.
Full PDUFA calendar ->Every upcoming FDA decision date, by monthLNTH-lnth-2501 . 2026-06-29Same area: Oncology . LNTH-2501 (Gallium-68 edotreotide)AZN-truqap . 2026-06-30Same area: Oncology . TruqapTLX . 2026-09-11Same month decision . TLX101-Px
Plain-English summary compiled by pdufa.bio from public FDA, SEC and company sources. Informational only - not investment advice.

PTGX run-up into the PDUFA (last ~120 days)

$112.46$82.76
Price path to 2026-06-19. Green = local high, red = low/sell-off. Historical price action, not a forecast.

Key facts

FDA decisionApproved August 28, 2026
Drug / candidateRusfertide
IndicationPolycythemia vera
CompanyProtagonist Therapeutics Inc.
Market-cap tierMid
Cohort decision-day move (history)±2% median
ClinicalTrials.govNCT04057040 · completed

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FAQ

What did the FDA decide on PTGX's Rusfertide?
The FDA decided PTGX's (Protagonist Therapeutics Inc.) application for Rusfertide on August 28, 2026: Approved. We do not state a goal date for this application: the date we had carried was never sourced to a filing or company release. Verify against the linked primary source.
What is PTGX's drug Rusfertide?
Rusfertide is Protagonist Therapeutics Inc.'s drug, approved by the FDA on August 28, 2026 for Polycythemia vera.
What typically happens to a mid-cap stock into a PDUFA date?
Historically, mid-cap names had a median decision-day move around ±2% (763-PDUFA cohort, 2024-26). This is historical context by market-cap tier, not a prediction for this drug.
Decision-day move · mid-cap cohortn=222 · median -0.0% · 49% up
under -30%: 5 of 222 (2%)<-30-30 to -15%: 6 of 222 (3%)-15 to -7%: 7 of 222 (3%)-7 to -3%: 21 of 222 (9%)-3 to +3%: 134 of 222 (60%)±3+3 to +7%: 34 of 222 (15%)+7 to +15%: 9 of 222 (4%)+15 to +30%: 1 of 222 (0%)over +30%: 5 of 222 (2%)>+30
Distribution of next-day % moves after the FDA decision for mid-cap PDUFAs (2020–26). Red = down, green = up, blue = flat (±3%). Historical dispersion, not a forecast.