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Description
FDA approves Sanofi’s Subcutaneous Sarclisa? is a decision window centered on a potential FDA approval for Sarclisa as a multiple myeloma treatment. The expected decision date is April 23, 2026, with final resolution by May 7, 2026, 11:59 PM ET. Approval is defined by an NDA/BLA letter, a supplemental NDA/BLA for new indications, an ANDA for generics, or a 351(k) biosimilar approval, including standard and accelerated routes or REMS-enabled approvals. If a Complete Response Letter or explicit decline occurs, the market resolves to No; if approval occurs within the period, it resolves to Yes; withdrawal by sponsor ends in No.
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1
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Markets
Outcome | Odds | Spread | 24h Change | 24h Volume | Total Volume | Liquidity | |
|---|---|---|---|---|---|---|---|
| FDA approves Sanofi’s Subcutaneous Sarclisa? | — | — | — | — | — | — |
Rules
As of market creation, the FDA’s expected decision date for the specified application is April 23, 2026. This market will resolve to "Yes" if the U.S. Food and Drug Administration (FDA) grants full or conditional approval for Sanofi’s Subcutaneous Sarclisa as a treatment for multiple myeloma by May 7, 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.