FDA approves Daiichi Sankyo & AstraZeneca's Enhertu?

요약

As of market creation, the FDA's expected decision date for the specified application is May 18, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Daiichi Sankyo & AstraZeneca's Enhertu as a treatment for neoadjuvant treatment of adult patients with HER2-positive breast cancer by June 1, 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 This market will immediately resolve to "No" if the FDA issues a Complete Response Letter (CRL) or explicitly declines to approve the application. If the drug sponsor withdraws the application before the end of the specified period, the market will resolve to "No" immediately. If the listed drug is approved before the end of the specified period, 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.

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이 마켓은 무엇에 관한 것인가요?

FDA approves Daiichi Sankyo & AstraZeneca's Enhertu? 이 마켓은 Polymarket에 설명된 규칙에 따라 2026. 5. 18.에 결제됩니다.

인트라마켓 차익거래는 어떻게 작동하나요?

모든 결과의 최선 매도 가격 합이 $1.00 미만이면, 각 결과를 매수하여 어떤 결과가 YES로 결제되더라도 $1.00의 지급을 보장받을 수 있습니다.

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이 카테고리의 Polymarket 테이커 수수료는 일반적으로 0%에서 1.8% 사이입니다. 주문하기 전에 Polymarket에서 실시간 수수료를 확인하세요.