FDA approves Retatrutide this year?
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Market pricing makes FDA approves Retatrutide this year? the favorite at 3%, as of .
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Eli Lilly on Thursday said it will file for approval of its next-generation obesity drug in the first quarter of 2027, as the treatment succeeds in two more late-stage trials. • • The pharmaceutical giant previously said it would submit an application as early as this year for the weekly injection, retatrutide, which works differently and appears to be more effective than existing shots and pills. In a statement to CNBC, Lilly said it needs more time to gather and verify the manufacturing and quality-control data required by regulators before it can seek approval. • • More:
Lilly's triple agonist heads to regulators after two more Phase 3 obesity wins. • Retatrutide, the obesity candidate that has shown the most powerful weight loss in late-stage trials, will be filed for approval early next year, its developer Eli Lilly said Thursday. The filing has been enabled by ...
Eli Lilly $LLY just said today it will file for approval of its next-generation weight loss drug "retatrutide" in the first quarter of 2027, as the treatment succeeds in two more late-stage trials - CNBC
Eli Lilly says it will file for approval of next-generation obesity drug in 2027 as it clears two more trials
Eli Lilly says it will file for approval of next-generation obesity drug in 2027 as it clears two more trials
The Wegovy pill showed more pronounced weight loss and less cumbersome side effects than Eli Lilly’s rival pill that was approved this week, Novo Nordisk said Thursday. • • Read more:
ELI LILLY'S STOCK JUMPED 3.8% AFTER FDA GAVE THE GREEN LIGHT TO A NEW OBESITY MEDICATION. ...
ELI LILLY'S STOCK JUMPED 3.8% AFTER FDA GAVE THE GREEN LIGHT TO A NEW OBESITY MEDICATION.
$NVO Novo Nordisk shares resilient as FDA approves Eli Lilly GLP-1 weight-loss pill to intensify competition @novonordisk #NVO
*ELI LILLY'S WEIGHT LOSS PILL FOUNDAYO GETS US APPROVAL ...
US approves new oral weight-loss pill developed by Eli Lilly
Lilly gains after FDA approves weight-loss pill, sizing down investor doubts
The U.S. FDA has approved Eli Lilly's oral obesity drug.
US Listed Shares of Novo Nordisk Down 1.9% After Rival Eli Lilly Wins FDA Approval Weight-Loss Pill
*FDA Approval Sets Up Weight-Loss-Pill Battle Between Eli Lilly, Novo Nordisk -- WSJ
*New Weight-Loss Pill From Eli Lilly Approved by FDA -- WSJ
ELI LILLY ANNOUNCES THAT QUALIFIED MEDICARE PART D PATIENTS COULD ACCESS FOUNDAYO FOR $50 A MONTH STARTING JULY 1, 2026. COMBINING FOUNDAYO WITH OTHER GLP-1 RECEPTOR AGONISTS IS NOT ADVISED. ...
ELI LILLY ANNOUNCES FOUNDAYO WILL BE OFFERED THROUGH LILLYDIRECT AT $25 PER MONTH WITH INSURANCE AND $149 FOR SELF-PAY. PRESCRIPTIONS WILL BE ACCEPTED RIGHT AWAY, WITH SHIPPING STARTING ON APRIL 6. ...
ELI LILLY ANNOUNCES THAT QUALIFIED MEDICARE PART D PATIENTS COULD ACCESS FOUNDAYO FOR $50 A MONTH STARTING JULY 1, 2026. COMBINING FOUNDAYO WITH OTHER GLP-1 RECEPTOR AGONISTS IS NOT ADVISED.
ELI LILLY'S FOUNDAYO IS NOW FDA APPROVED FOR ADULTS WITH OBESITY AND WEIGHT-RELATED HEALTH ISSUES. IT CAN BE TAKEN ANYTIME, WITH NO FOOD OR WATER RESTRICTIONS. • • ELI LILLY ANNOUNCES FOUNDAYO WILL BE OFFERED THROUGH LILLYDIRECT AT $25 PER MONTH WITH INSURANCE AND $149 FOR SELF-PAY. PRESCRIPTIONS WILL BE ACCEPTED RIGHT AWAY, WITH SHIPPING STARTING ON APRIL 6.
ELI LILLY ANNOUNCES FOUNDAYO WILL BE OFFERED THROUGH LILLYDIRECT AT $25 PER MONTH WITH INSURANCE AND $149 FOR SELF-PAY. PRESCRIPTIONS WILL BE ACCEPTED RIGHT AWAY, WITH SHIPPING STARTING ON APRIL 6.
Eli Lilly Shares Up 4% After US FDA Approves Co’s Weight Loss Pill Foundayo
FDA approves Eli Lilly's GLP-1 pill, opening the next phase of the weight loss drug market
ELI LILLY: FDA APPROVED FOUNDAYO FOR ADULTS WITH OBESITY/OVERWEIGHT WITH WEIGHT - REPORTS
Eli Lilly: Use of Foundayo with Other Glp-1 Receptor Agonist Medicines is Not Recommended
Eli Lilly: Foundayo Will Be Available with Prescriptions Accepted Immediately & Shipping From April 6
Eli Lilly: FDA Approved Foundayo for Adults with Obesity/Overweight with Weight-Related Medical Problems
What is this event about?
Retatrutide is a triple agonist hormone/peptide drug developed by Eli Lilly and currently in trial to treat obesity, fatty liver disease, type-2 diabetes, knee osteoarthritis, and more.
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.