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  1. Prediction Markets
  2. Regulation
  3. FDA decision: DTX401 (pariglasgene brecaparvovec) by Ultragenyx Pharmaceutical (in 2026)
FDA decision: DTX401 (pariglasgene brecaparvovec) by Ultragenyx Pharmaceutical (in 2026)

FDA decision: DTX401 (pariglasgene brecaparvovec) by Ultragenyx Pharmaceutical (in 2026)

RegulationOne-OffHealth & Medicine6mo
KalshiKalshiCheck availabilityKYC required2% fee
Current implied probability
Yes
Yes 0%
Market quality

24 / 100

Low quality
24h Volume

$0

Liquidity

$0

Low liquidity
Bid / Ask

61.0% / 69.0%

Spread

13.1%

Wide spread
Market data

Updated 3 minutes ago

Jun 17, 26, 9:00 PMJan 1, 27, 4:59 AM

Trends

Outcome24hChance
Yes
Yes
0%
No
No
100%

Selected outcome

Yes0%

Rules

If the FDA's decision on DTX401 (pariglasgene brecaparvovec) by Ultragenyx Pharmaceutical in 2026 is a full approval or an accelerated approval, the market resolves to Yes.

Kalshi
  • This market will resolve to No if the FDA's decision is a denial (CRL issued), a withdrawal by the sponsor, or a conditional approval — or if no decision is issued.
  • DTX401 (pariglasgene brecaparvovec) is a one-time gene therapy developed by Ultragenyx Pharmaceutical to treat Glycogen Storage Disease Type Ia (GSDIa), a rare inherited disorder in which the liver cannot properly release stored sugar into the bloodstream.
  • Think of it like installing a corrected instruction manual inside liver cells: after a single infusion, the therapy is designed to restore the missing enzyme activity — glucose-6-phosphatase — so the liver can once again regulate blood sugar on its own.
  • In the Phase 3 GlucoGene trial , DTX401 produced a statistically significant 41.3% mean reduction in daily cornstarch intake at Week 48 versus 10.3% for placebo (p<0.0001), with durability data at 96 weeks showing approximately 60–61% reductions.

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Rules

If the FDA's decision on DTX401 (pariglasgene brecaparvovec) by Ultragenyx Pharmaceutical in 2026 is a full approval or an accelerated approval, the market resolves to Yes.

Kalshi
  • This market will resolve to No if the FDA's decision is a denial (CRL issued), a withdrawal by the sponsor, or a conditional approval — or if no decision is issued.
  • DTX401 (pariglasgene brecaparvovec) is a one-time gene therapy developed by Ultragenyx Pharmaceutical to treat Glycogen Storage Disease Type Ia (GSDIa), a rare inherited disorder in which the liver cannot properly release stored sugar into the bloodstream.
  • Think of it like installing a corrected instruction manual inside liver cells: after a single infusion, the therapy is designed to restore the missing enzyme activity — glucose-6-phosphatase — so the liver can once again regulate blood sugar on its own.
  • In the Phase 3 GlucoGene trial , DTX401 produced a statistically significant 41.3% mean reduction in daily cornstarch intake at Week 48 versus 10.3% for placebo (p<0.0001), with durability data at 96 weeks showing approximately 60–61% reductions.