Kalshi has settled 19 FDA-approval contracts on 5 drugs; 3 of those drugs are now approved, and every approval date matches the FDA’s Drugs@FDA record.
We matched each contract to the FDA’s own approval record, priced it a day and a month before the decision, and checked whether the live deadline ladders hang together. For context, Drugs@FDA lists 58 original new-molecular-entity NDAs and BLAs approved so far in 2026, against 59 by this date last year.
Kalshi market data and FDA Drugs@FDA, pulled Oct 23, 2026, 8:36 AM ET. Updated daily.
By Arthur Angelo, PredictionScout Research · Updated Oct 23, 2026, 8:36 AM ET
Key findings
- Settlements check out. 19 of 19 settled contracts agree with Drugs@FDA: Yes when the approval date fell before the contract’s deadline, No otherwise.
- Approvals. baxdrostat: BAXFENDY (NDA219878, ASTRAZENECA AB) approved May 15, 2026, Kalshi settled 3 days later; camizestrant: ETCAMAH (NDA220359, ASTRAZENECA) approved Sep 4, 2026, Kalshi settled 4 days later; gedatolisib: REVTORPYK (NDA219908, CELCUITY) approved Jul 14, 2026, Kalshi settled the same day.
- Priced before the news. A day before each approval, the contracts that went on to pay Yes traded at a median 74¢; a month before, 65.5¢. The 7 that expired No were at a median 2¢ a day before their deadline.
- Still waiting. CagriSema: before Jan 2027 68%, before Jul 2027 94%, before Jan 2028 92%; cytisinicline (smoking cessation): before Jan 2027 12%, before Jul 2027 38%; midomafetamine / MDMA (PTSD): before Jan 2027 10%, before Jan 2028 34%, before Jan 2029 52%, before Jan 2030 52%, before Jan 2031 53%, before Jan 2032 52%; intismeran autogene (V940) with Keytruda, for melanoma: before Apr 2027 4%, before Jul 2027 14%, before Oct 2027 66%, before Jan 2028 88%, before Jul 2028 95%.
Every settled FDA-approval contract
“1 day before” is the price the day before the FDA’s approval for contracts that paid Yes, or the day before the deadline for those that expired No. Prices are the daily bid/ask midpoint, or the last trade when the spread is wider than 10¢.
| Drug | Deadline | Result | 1 day before | 30 days before | FDA record |
|---|---|---|---|---|---|
| CagriSema | Jul 1, 2026 | No | 1¢ | 18.5¢ | No approval in Drugs@FDA |
| CagriSema | Oct 1, 2026 | No | 1.5¢ | 15¢ | No approval in Drugs@FDA |
| baxdrostat | Jun 1, 2026 | Yes | 18¢ | — | NDA219878 approved May 15, 2026 |
| baxdrostat | Jul 1, 2026 | Yes | 61.5¢ | — | NDA219878 approved May 15, 2026 |
| baxdrostat | Aug 1, 2026 | Yes | 75¢ | — | NDA219878 approved May 15, 2026 |
| baxdrostat | Sep 1, 2026 | Yes | 85¢ | — | NDA219878 approved May 15, 2026 |
| baxdrostat | Jan 1, 2027 | Yes | 90¢ | — | NDA219878 approved May 15, 2026 |
| camizestrant | Jun 1, 2026 | No | 1¢ | — | NDA220359 approved Sep 4, 2026 |
| camizestrant | Jul 1, 2026 | No | 3.5¢ | 14.5¢ | NDA220359 approved Sep 4, 2026 |
| camizestrant | Oct 1, 2026 | Yes | 39.5¢ | 34¢ | NDA220359 approved Sep 4, 2026 |
| camizestrant | Jan 1, 2027 | Yes | 53.5¢ | 60¢ | NDA220359 approved Sep 4, 2026 |
| camizestrant | Jan 1, 2028 | Yes | 72¢ | 74¢ | NDA220359 approved Sep 4, 2026 |
| cytisinicline | Jul 1, 2026 | No | 2¢ | 6¢ | No approval in Drugs@FDA |
| cytisinicline | Oct 1, 2026 | No | 3.5¢ | 7.5¢ | No approval in Drugs@FDA |
| gedatolisib | Jul 1, 2026 | No | 8¢ | 32¢ | NDA219908 approved Jul 14, 2026 |
| gedatolisib | Aug 1, 2026 | Yes | 73¢ | 62¢ | NDA219908 approved Jul 14, 2026 |
| gedatolisib | Oct 1, 2026 | Yes | 78.5¢ | 65.5¢ | NDA219908 approved Jul 14, 2026 |
| gedatolisib | Jan 1, 2027 | Yes | 81¢ | 71.5¢ | NDA219908 approved Jul 14, 2026 |
| gedatolisib | Jul 1, 2027 | Yes | 80¢ | 80.5¢ | NDA219908 approved Jul 14, 2026 |
Live approval odds
Each drug has a ladder of deadlines. The chance for a later deadline should never be lower than for an earlier one.
| Drug | Indication | Approved before | Chance now | Volume |
|---|---|---|---|---|
| CagriSema | Jan 1, 2027 | 68% | 1,093 | |
| CagriSema | Jul 1, 2027 | 94% | 2,168 | |
| CagriSema | Jan 1, 2028 | 92% | 1,346 | |
| cytisinicline | smoking cessation | Jan 1, 2027 | 12% | 385 |
| cytisinicline | smoking cessation | Jul 1, 2027 | 38% | 1,026 |
| intismeran autogene (V940) with Keytruda, for melanoma | adjuvant treatment of completely resected stage IIB-IV melanoma | Apr 1, 2027 | 4% | 0 |
| intismeran autogene (V940) with Keytruda, for melanoma | adjuvant treatment of completely resected stage IIB-IV melanoma | Jul 1, 2027 | 14% | 37 |
| intismeran autogene (V940) with Keytruda, for melanoma | adjuvant treatment of completely resected stage IIB-IV melanoma | Oct 1, 2027 | 66% | 873 |
| intismeran autogene (V940) with Keytruda, for melanoma | adjuvant treatment of completely resected stage IIB-IV melanoma | Jan 1, 2028 | 88% | 1,188 |
| intismeran autogene (V940) with Keytruda, for melanoma | adjuvant treatment of completely resected stage IIB-IV melanoma | Jul 1, 2028 | 95% | 0 |
| midomafetamine / MDMA | PTSD | Jan 1, 2027 | 10% | 1,286 |
| midomafetamine / MDMA | PTSD | Jan 1, 2028 | 34% | 833 |
| midomafetamine / MDMA | PTSD | Jan 1, 2029 | 52% | 2,555 |
| midomafetamine / MDMA | PTSD | Jan 1, 2030 | 52% | 3,475 |
| midomafetamine / MDMA | PTSD | Jan 1, 2031 | 53% | 2,845 |
| midomafetamine / MDMA | PTSD | Jan 1, 2032 | 52% | 2,157 |
The FDA’s count
Original new-molecular-entity NDAs (Drugs@FDA class “Type 1”) and original BLAs marked approved, by year of approval. Drugs@FDA was last updated 2026-10-16. It covers drugs regulated by CDER, so vaccines and other CBER products are not counted, and the total can differ from the FDA’s published “novel drug approvals” list.
| Year | NME NDAs | BLAs | Total |
|---|---|---|---|
| 2026 | 33 | 25 | 58 |
| 2025 | 34 | 52 | 86 |
| 2024 | 33 | 44 | 77 |
| 2023 | 36 | 29 | 65 |
| 2022 | 21 | 25 | 46 |
| 2021 | 32 | 21 | 53 |
| 2020 | 40 | 22 | 62 |
| 2019 | 37 | 23 | 60 |
| 2018 | 38 | 24 | 62 |
| 2017 | 32 | 24 | 56 |
| 2016 | 12 | 15 | 27 |
| 2015 | 28 | 19 | 47 |
Download the data
Settled Kalshi FDA contracts vs Drugs@FDA (CSV)Drugs@FDA original NME NDAs and BLAs by year (CSV)
One row per settled contract with its FDA match and two snapshot prices, and Drugs@FDA approval counts by year. No price histories are included. Free to reuse under CC BY 4.0 with a link back to this page.
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Methodology
- Markets. Every contract in Kalshi’s
KXFDAAPPROVEseries. Each asks whether the FDA approves a named drug for a named use before a date, as shown by an FDA approval letter or announcement. - FDA record. The full Drugs@FDA download from openFDA, matched by active ingredient. We take the original application (submission type ORIG) with status “AP” and its status date.
- Prices. Daily candle closes from Kalshi’s public API: the bid/ask midpoint, or last trade if the spread is wider than 10¢, looking back up to 30 days because these contracts trade rarely.
- Check. A contract should pay Yes exactly when the Drugs@FDA approval date is before its deadline.
- Limits. Kalshi has listed FDA markets on only 7 drugs, and they trade thinly, so prices can be stale. Drugs@FDA covers CDER products only. Matching is by active ingredient, and Drugs@FDA does not list the approved indication, so we did not check that each approval covers the exact use a contract names. Nothing here is investment advice. Last run: Oct 23, 2026, 8:36 AM ET.
Cite this research
Suggested citation: PredictionScout. (2026, October 23). FDA Approval Prediction Markets vs FDA Records. https://predictionscout.com/research/fda-approval-prediction-markets/
For a chart or news story: “Source: PredictionScout analysis of public exchange data (https://predictionscout.com/research/fda-approval-prediction-markets/)”
The data and charts on this page are free to reuse under CC BY 4.0 with a link back to this page. Market data: Kalshi. Approvals: U.S. Food and Drug Administration, Drugs@FDA (openFDA).
Data sources: prices and volumes come from the public APIs of Kalshi and Polymarket, with approvals from FDA Drugs@FDA via openFDA. All trademarks belong to their owners. PredictionScout is independent and not affiliated with any exchange. Nothing here is investment, betting, or legal advice.
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