Kalshi Platform Opens Betting Markets on Drug Trials and FDA Rulings

Prediction market platform Kalshi announced Thursday that it will begin offering bets on the outcomes of clinical drug trials and decisions made by the U.S. Food and Drug Administration — a first-of-its-kind move that makes drug-development odds publicly available for wagering.

The new betting markets are being launched in collaboration with AppliedXL, a company that tracks and forecasts the results of clinical trials.

According to Kalshi, the markets give investors the ability to take a position on a specific drug rather than placing a broader bet on an entire pharmaceutical company.

As part of an initial pilot program, participants will only be permitted to wager on the outcomes of late-stage clinical trials. A contract will only be listed after a trial has completed its enrollment process.

Each contract will be grounded in a specific, named public document — such as the registered primary endpoint listed on ClinicalTrials.gov, an FDA approval letter, or the voting record from the agency’s advisory committee.

AppliedXL will establish the criteria for interpreting those documents before a contract becomes available for trading — not after results are announced.

Among the contracts available at launch are more than a dozen FDA decisions, including whether the agency will approve Gilead’s experimental cancer drug, anito-cel, and Summit Therapeutics’ experimental lung cancer drug, ivonescimab. Traders will also be able to bet on whether an early Alzheimer’s disease drug being developed by AriBio will meet the primary goals of a late-stage trial.

The platform will require employment verification for all participants and will ban anyone who possesses material nonpublic information from placing trades.

Kalshi, which launched in 2021, currently allows users to place bets on events ranging from sports and elections to weather outcomes.