Eli Lilly’s July 2026 announcement that it will file a Biologics License Application for retatrutide, its investigational GIP/GLP-1/glucagon triple agonist, only in Q1 2027 underpins the 94.5% market-implied probability against 2026 FDA approval. Multiple positive Phase 3 TRIUMPH readouts this year, including up to 22.6% mean weight loss at 80 weeks in high-risk populations, have strengthened the clinical package, yet the company is still completing chemistry, manufacturing, and controls data required for submission. Standard FDA review timelines of 10–12 months make approval before year-end improbable even under priority review. Trader consensus reflects these regulatory milestones rather than efficacy concerns. A surprise late-2026 filing or expedited designation could theoretically shift odds, though current company guidance and historical precedent render such outcomes unlikely.
Eksperymentalne podsumowanie AI odwołujące się do danych Polymarket. To nie jest porada handlowa i nie ma wpływu na rozstrzyganie tego rynku. · ZaktualizowanoFDA zatwierdza Retatrutide w tym roku?
Tak
$583,130 Wol.
$583,130 Wol.
Tak
$583,130 Wol.
$583,130 Wol.
This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for Eli Lilly’s for a drug product whose active ingredient is Eli Lilly’s retatrutide (including any brand name or identifier such as LY3437943) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
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) application
The following constitute qualifying approvals:
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 programs
The following do not constitute qualifying approvals:
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
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved within this market’s timeframe, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Rynek otwarty: Jan 12, 2026, 5:52 PM ET
Rozstrzygający
0x65070BE91...This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants a full or conditional approval for Eli Lilly’s for a drug product whose active ingredient is Eli Lilly’s retatrutide (including any brand name or identifier such as LY3437943) for any use between market creation and December 31, 2026, 11:59 PM ET. Otherwise, this market will resolve to "No."
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) application
The following constitute qualifying approvals:
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 programs
The following do not constitute qualifying approvals:
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
Approval only for export or for use outside the United States
Emergency Use Authorization (EUA) without full approval
Complete Response Letters (CRLs) indicating the application cannot be approved in its current form
If the listed drug is approved within this market’s timeframe, the market will resolve to "Yes," regardless of potential Advisory Committee votes against approval or later withdrawal of approval.
Conditional approvals may include post-marketing requirements or commitments and still qualify.
The primary resolution source will be official information from the FDA; however, a consensus of credible reporting will also be used.
Rozstrzygający
0x65070BE91...Eli Lilly’s July 2026 announcement that it will file a Biologics License Application for retatrutide, its investigational GIP/GLP-1/glucagon triple agonist, only in Q1 2027 underpins the 94.5% market-implied probability against 2026 FDA approval. Multiple positive Phase 3 TRIUMPH readouts this year, including up to 22.6% mean weight loss at 80 weeks in high-risk populations, have strengthened the clinical package, yet the company is still completing chemistry, manufacturing, and controls data required for submission. Standard FDA review timelines of 10–12 months make approval before year-end improbable even under priority review. Trader consensus reflects these regulatory milestones rather than efficacy concerns. A surprise late-2026 filing or expedited designation could theoretically shift odds, though current company guidance and historical precedent render such outcomes unlikely.
Eksperymentalne podsumowanie AI odwołujące się do danych Polymarket. To nie jest porada handlowa i nie ma wpływu na rozstrzyganie tego rynku. · Zaktualizowano


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