BackKKALSHI

Will the FDA approve gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer before Jul 1, 2027?

Yes1%

Vol$0.00

Outcomes2

1%

TradeTrade on Kalshi

MarketKALSHIactive

Will the FDA approve gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer before Jul 1, 2027?

MarketKALSHIactiveOther

Will the FDA approve gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer before Jul 1, 2027?

Part of: Will the FDA approve gedatolisib for advanced breast cancer?

NoNo Price

99¢

|

VolTotal Volume

$0.00

|

Outcomes

2

Ends

Jul 8, 2027

in 12 months

Trade on Kalshi

Will the FDA approve gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer before Jul 1, 2027?

Will the FDA approve gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer before Jul 1, 2027?

No

99¢

|

Vol

$0.00

|

Outcomes

2

Yes0.9¢

No99.1¢

Price History

Will the FDA approve gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer before Jul 1, 2027?

No historical data available

Price history will appear here when available

Resolution Info

Market Stats

Resolution Countdown

363 Days Left

July 08, 2027 • 2:00 PM

Last Updated

less than a minute ago

Will the FDA approve gedatolisib for advanced breast cancer?

Will the FDA approve gedatolisib for advanced breast cancer?

Resolution Information

Status

Active

Expected Resolution

July 08, 2027

2:00 PM GMT+0

Official Sources

Markets are resolved using official government and institutional sources.

Accuracy

100%

Resolved

8,750

Avg Time

< 24 hours

Disputes

0%

Resolution Criteria

If the FDA approves gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer for marketing before Jul 1, 2027, then the market resolves to Yes. 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 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 programs The 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 States If the FDA issues a Complete Response Letter before Jul 1, 2027, the market will resolve to No unless the FDA subsequently approves gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer after addressing the CRL concerns and before Jul 1, 2027. If the FDA convenes an Advisory Committee that votes against approval but the FDA approves gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer anyway before Jul 1, 2027, the market will resolve to Yes. If gedatolisib for HR+/HER2-, PIK3CA wild-type advanced breast cancer receives accelerated approval that is later withdrawn before Jul 1, 2027, 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 Jul 1, 2027, the market will resolve to No immediately. This market will close and expire early if the event occurs.

Market Still Active

This market has not yet resolved. Resolution will occur after the specified end date based on the criteria above.