FDA approves AstraZeneca's Camizestrant?

Prediction market · Polymarket

Overview

As of market creation, the FDA's expected decision date for the specified application is April 30, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for AstraZeneca's Camizestrant as a treatment for HR+/HER2- advanced or metastatic breast cancer with ESR1 mutation by May 14, 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.

Ticker

fda-approves-astrazenecas-camizestrant

Volume

362

24h volume

360

1w volume

362

Open interest

310

Liquidity

1.6K

Liquidity CLOB

1.6K

Start

Apr 20, 2026

End

Apr 30, 2026

Status

Active

Access

Restricted

Created

Apr 20, 2026

Event ID

400551

Slug

fda-approves-astrazenecas-camizestrant

Markets

1

Tags

FDATechBusinessMedicineSciencedrug
Raw event data
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    "context_description": "Trader consensus on Polymarket reflects a 74% implied probability against FDA approval of AstraZeneca's camizestrant—a next-generation oral selective estrogen receptor degrader (SERD)—by the May 14 resolution deadline, driven by regulatory scrutiny ahead of the April 30 Oncologic Drugs Advisory Committee (ODAC) meeting reviewing NDA 220359. This marks the FDA's first cancer advisory panel in nine months, signaling potential concerns over SERENA-6 Phase 3 data showing a 56% progression-free survival (PFS) benefit in ESR1-mutated, HR-positive/HER2-negative advanced breast cancer patients switching from first-line endocrine therapy plus CDK4/6 inhibitors. While topline results from June 2025 were compelling, lack of overall survival maturity and competition from approved SERDs like imlunestrant fuel skepticism; ODAC recommendations and any post-meeting FDA action remain key catalysts.",
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