Kalshi, the next-generation financial exchange, today announced a partnership with public intelligence company AppliedXL to launch a pilot suite of prediction markets on clinical trial outcomes and FDA regulatory decisions. The markets will create publicly available, accurate probabilities aiming to help solve drug development's information silo problem.
The odds that a drug will succeed are among the most valuable numbers in the economy, and among the least visible. The average cost to bring a single drug to market is an estimated $2.3 billion, according to McKinsey, and a company's fortunes can turn on a single trial result. Banks, expert networks, and pharmaceutical companies all produce estimates, but they stay behind closed doors. Even the official public record is incomplete: as of the FDA's April 2026 figures, roughly 30% of trials required to report their results had posted none.
These markets close that gap. A publicly listed contract on a trial or regulatory outcome produces a continuously updated, public probability that reflects the weight of the evidence rather than the preferred messaging of the trial sponsor. Because the price now moves on the public record rather than on privileged access, people who were never in the room — investors allocating capital, smaller developers weighing where to compete, clinicians and patients tracking a program — can all read the same number.
"Drug development is one of the most important and most information-constrained industries on earth. 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."
The markets also give investors something they have never had: a way to act on a view about a single drug. Public equities force a position on the whole business at once — on management, cash, pipeline, and macro together. An investor can be right about the science or the regulatory outcome and still watch the stock move the other way. These contracts isolate the single question. Owning the stock is still owning the whole company; a contract prices the science or the regulatory outcome on its own terms.
How the markets resolve
AppliedXL, a public intelligence company tracking pharmaceutical data, provides the resolution infrastructure underpinning the markets. Each contract specifies a named public document as its resolution source: the registered primary endpoint on ClinicalTrials.gov — meaning the main result the trial was designed to measure — the FDA approval letter, or the advisory committee vote record. AppliedXL defines the criteria for reading that document before the contract opens for trading, not after results arrive. Outcomes are determined by independent public artifacts, not by sponsor communications or analyst interpretation, making resolution transparent, auditable, and resistant to dispute.
"Clinical trial results are rarely handed to you cleanly. 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."
Example contracts available at launch include:
Will AR1001's POLARIS-AD Phase 3 trial meet its primary endpoint in early Alzheimer's disease?
Will the FDA approve Gilead/Arcellx's anito-cel for relapsed/refractory multiple myeloma?
Alongside today's launch, Kalshi and AppliedXL are publishing Biopharma's Public Probability: The State and Future of Prediction Markets in Drug Development, a joint whitepaper drawing on interviews with clinicians, academics, biopharma R&D and strategy professionals, bioethicists, and investors. It examines the opportunities and challenges these markets present, and the standards required for them to function reliably.
Scope and safeguards
These initial markets are a pilot program, deliberately constrained to protect both the integrity of the markets and the integrity of the trials they price. Working with biopharma R&D and strategy professionals, biotech investors, physicians, and bioethicists, Kalshi and AppliedXL built two design choices into the pilot:
Late-stage trials. Earlier-phase contracts involve exploratory endpoints and greater insider trading risk. Late-stage trials register their primary endpoints publicly, often after agreeing them with the FDA in advance, making resolution unambiguous.
Listing only after enrollment closes. A visible market price could influence physician referral and recruitment. Kalshi and AppliedXL list a contract only after a trial finishes enrolling.
Employment verification. Kalshi will require employment verification for all traders in these markets as an additional integrity measure.
On top of these pilot-specific choices, Kalshi's existing rules apply in full. The prohibition on trading by anyone who holds material nonpublic information applies here exactly as it does in every other Kalshi market.
Kalshi and AppliedXL will study how these markets perform and how traders engage with them, using what they learn to refine the market design and the guardrails ahead of any potential broader release.
