Kalshi Launches Prediction Markets for Clinical Trials and FDA Decisions

Prediction market Kalshi and public intelligence company AppliedXL have launched a pilot program that allows trading on clinical trial outcomes and Food and Drug Administration (FDA) regulatory decisions.

The companies said in a Thursday (July 16) press release that examples of the contracts available at launch include “Will AR1001’s POLARIS-AD Phase 3 trial meet its primary endpoint in early Alzheimer’s disease?” and “Will the FDA approve Gilead/Arcellx’s anito-cel for relapsed/refractory multiple myeloma?”

These prediction markets make drug-development odds public, continuously updated and based on evidence beyond that supplied by the trial sponsor, according to the release.

The markets also enable investors to act on their view about a single drug, rather than the whole business at once as is required by public equities, the release said.

Together with Kalshi’s existing rules, the pilot program will have additional measures designed to prevent insider trading, per the release.

“Drug development is one of the most important and most information-constrained industries on earth,” Kalshi CEO Tarek Mansour said in the release. “The data that determines which drugs advance and which don’t is largely locked away from the people who need it most. 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, which tracks pharmaceutical data, will provide the resolution infrastructure underpinning these new markets, per the release.

“Clinical trial results are rarely handed to you cleanly,” AppliedXL Co-Founder and CEO Francesco Marconi said in the release. “They come out in pieces, scattered across registries, regulatory filings and company statements, and the press releases often put a favorable spin on what the data actually shows. Resolving a market means reconciling all of that back to the primary source, which is what we built AppliedXL to do.”

PYMNTS reported in October 2025 that the momentum in the prediction market space is being driven in part by a market architecture that allows trading on a broad range of products, including finance, culture, politics, entertainment, weather and sports.

It was reported in April that Wall Street broker Bernstein expects prediction market volume to increase from $51 billion last year to $240 billion this year and $1 trillion by 2030.