When will the FDA approve retatrutide (LY3437943)?: Before Jan 1, 2028
Share
Yes price and rules edits
Resolution
Checking the live resolution stage with Kalshi…
Rules history
- 1Version 1, currentsince I first saw it,
Read the current rules
- Title
- When will the FDA approve retatrutide (LY3437943)?
- Outcome
- Before Jan 1, 2028
- Rules
If the FDA approves retatrutide (LY3437943) for marketing before Jan 1, 2028, then the market resolves to Yes.
- More rules
An approval is defined as:
For new drugs: FDA issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA)
For already-marketed drugs seeking new indications: FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced
For generic drugs: FDA approval of an Abbreviated New Drug Application (ANDA)
For biosimilars: FDA approval of a 351(k) applicationThe following constitute approvals that trigger the Payout Criterion:
Standard approval (traditional approval based on clinical benefit)
Accelerated approval (based on surrogate endpoints)
Approval with Risk Evaluation and Mitigation Strategy (REMS)
Approval with restricted distribution or indication limitations, except compassionate use/expanded access programsThe following do NOT constitute approvals:
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
Approvable letters that require additional actions before approval
Tentative approvals pending patent or exclusivity expiration
FDA requests for additional information or studies
Extension of Prescription Drug User Fee Amendments dates
Approval for compassionate use or expanded access programs only
Emergency Use Authorization (EUA) without full approval
Approval only for export or for use outside the United StatesIf the FDA issues a Complete Response Letter before Jan 1, 2028, the market will resolve to No unless the FDA subsequently approves retatrutide (LY3437943) after addressing the CRL concerns and before Jan 1, 2028.
If the FDA convenes an Advisory Committee that votes against approval but the FDA approves retatrutide (LY3437943) anyway before Jan 1, 2028, the market will resolve to Yes.
If retatrutide (LY3437943) receives accelerated approval that is later withdrawn before Jan 1, 2028, the market will resolve based on whether the initial accelerated approval occurred after Issuance (Yes), regardless of the subsequent withdrawal.
If the drug sponsor withdraws the application before FDA action and before Jan 1, 2028, the market will resolve to No immediately.
- Close time
- Jan 1, 2028, 04:59 UTC
- Expiration
- Jan 8, 2028, 15:00 UTC
- Early close
This market will close and expire early if the event occurs.
- 1First recordedOct 31, 2026, 09:23 UTC
Saved in my first snapshot of every open market. Neither venue keeps older versions, so nothing before this exists.
Clarifications posted elsewhere
No links added.