Kalshi has partnered with public intelligence company AppliedXL to launch a pilot suite of prediction markets tied to clinical trial outcomes and FDA regulatory decisions.
The initiative, structured as a pilot program, gives traders a way to bet on individual drug programs rather than on the stock of the company developing them.
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 their own estimates of a drug’s odds of success, but those figures stay behind closed doors, argues Kalshi. Even the public record is incomplete: as of the FDA’s April 2026 figures, roughly 30% of trials required to report their results had posted none.
Kalshi said a publicly listed contract on a trial or regulatory outcome would produce a “continuously updated, public probability that reflects the weight of the evidence, rather than the preferred message of the trial sponsor.”
“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,” Kalshi CEO Tarek Mansour said in a statement.
The contracts also give investors a way to act on a view about a single drug that public equities do not allow. A stock price forces a position on an entire company at once, tied to management, cash position, pipeline, and macro conditions together, so an investor can be right about the science or the regulatory outcome and still watch the share price move the other way.
A prediction contract isolates that single question instead, says Kalshi.
How the contracts resolve
AppliedXL, a public intelligence company that tracks pharmaceutical data, supplies the resolution infrastructure for the markets.
Each contract names a specific public document as its resolution source: the registered primary endpoint on ClinicalTrials.gov, the FDA approval letter, or the advisory committee vote record.
AppliedXL sets the criteria for reading that document before a contract opens for trading, not after results arrive, so outcomes rely on independent public artifacts rather than sponsor communications or analyst interpretation.
“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,” said Francesco Marconi of AppliedXL.
Sample contracts available at launch include whether AR1001’s POLARIS-AD Phase 3 trial will meet its primary endpoint in early Alzheimer’s disease, and whether the FDA will approve Gilead/Arcellx’s anito-cel for relapsed or refractory multiple myeloma.
Safeguards built into the pilot
Kalshi and AppliedXL developed the pilot with input from biopharma R&D and strategy professionals, biotech investors, physicians and bioethicists, and built in two structural limits. Contracts cover only late-stage trials, since earlier-phase studies involve exploratory endpoints and carry greater insider trading risk, while late-stage trials register their primary endpoints publicly, often after agreeing them with the FDA in advance.
The companies also list a contract only after a trial finishes enrolling, since a visible market price before that point could influence physician referral and patient recruitment.
Kalshi will additionally require employment verification for all traders in these markets. That measure sits on top of the exchange’s existing rules, including its prohibition on trading by anyone who holds material nonpublic information, which applies to the drug trial markets exactly as it does across the rest of the platform.
Kalshi and AppliedXL said they would study how the markets perform and how traders engage with them, and use those findings to refine the design and guardrails ahead of any potential wider release.
Industry voices in a new whitepaper
Alongside the launch, Kalshi and AppliedXL published a 44-page whitepaper titled “Biopharma’s Public Probability: The State and Future of Prediction Markets in Drug Development,” drawing on interviews with clinicians, academics, biopharma R&D and strategy professionals, bioethicists and investors.
The paper includes commentary from 23andMe founder Anne Wojcicki, who wrote that the clinical trial process remains difficult for most patients to follow.
“Most patients don’t know about the choices available in clinical trials or which programs are most promising,” Wojcicki wrote. “The opportunity to have an open, transparent dataset about trial probabilities is extremely promising and empowering for people.”
The clinical trial launch arrives as prediction platforms including Kalshi face criticism over their exposure to manipulation and insider trading.
Federal regulators have told US media that Donald Trump’s longtime teleprompter operator made tens of thousands of dollars on bets tied to the president’s speeches.
The Department of Justice last month also opened an investigation into former Republican congressman George Santos of New York over whether he engaged in insider trading by betting on his own attendance at the State of the Union address.
In April, several congressional candidates were fined for betting on the outcomes of their own races.