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# Kalshi Launches Prediction Markets for Clinical Trial, FDA Outcomes
- URL: https://www.fdaweb.com/kalshi-launches-prediction-markets-for-clinical-trial-fda-outcomes/
- Published: 2026-07-16T12:00:00.000Z
- Updated: 2026-09-14T13:43:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5161472

Quasi betting platform Kalshi has launched a pilot program allowing traders to buy and sell contracts tied to the outcomes of late-stage clinical trials and FDA regulatory decisions, creating what the company says will be the first publicly available, continuously updated probabilities for drug development milestones.

The initiative, announced in partnership with public intelligence company AppliedXL, will initially focus on late-stage clinical trials and FDA approval decisions, with contracts resolving based on predefined public documents such as *ClinicalTrials.gov* trial results, FDA approval letters or advisory committee vote records.

Kalshi said the markets are intended to address what it described as an information gap in drug development, where estimates of a drug's likelihood of success are typically generated by pharmaceutical companies, investment banks and consulting firms but remain largely proprietary. "The odds that a drug will succeed are among the most valuable numbers in the economy, and among the least visible," the company said.

According to Kalshi, publicly traded prediction contracts could provide investors, drug developers, clinicians and patients with a transparent, market-based assessment of a therapy's probability of success rather than relying solely on company press releases or analyst reports.

"Drug development is one of the most important and most information-constrained industries on earth," Kalshi CEO **Tarek Mansour** said in a statement. "Surfacing information is what Kalshi is for, and we are committed to doing it right: compliance-first, carefully scoped, and built for the long term."

AppliedXL will provide the infrastructure used to determine contract outcomes. Before trading begins, each market specifies the public document that will determine whether the contract resolves as "yes" or "no," reducing the role of sponsor communications or analyst interpretation.

Among the first contracts available are markets on whether AriBio's Phase 3 POLARIS-AD trial of AR1001 will meet its primary endpoint in early Alzheimer's disease and whether FDA will approve Gilead Sciences and Arcellx's investigational CAR-T therapy anitocabtagene autoleucel (anito-cel) for relapsed or refractory multiple myeloma.