FDA approves Sanofi’s Subcutaneous Sarclisa?

Prediction market · Polymarket

Overview

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.

Ticker

fda-approves-sanofis-sarclisa

Volume

952

24h volume

762

1w volume

952

Open interest

638

Liquidity

6.3K

Liquidity CLOB

6.3K

Start

Apr 17, 2026

End

Apr 23, 2026

Status

Active

Access

Restricted

Created

Apr 17, 2026

Event ID

382921

Slug

fda-approves-sanofis-sarclisa

Markets

1

Tags

ScienceTechRewards 50, 4.5, 20MedicineFDABusinessdrug
Raw event data
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  "eventMetadata": {
    "context_description": "Trader consensus prices an 84% implied probability for FDA approval of Sanofi’s subcutaneous Sarclisa (isatuximab-irfc), a CD38-directed monoclonal antibody for relapsed/refractory multiple myeloma, as the PDUFA target action date looms on April 23—just days away. This reflects robust phase 3 IRAKLIA trial results from January 2025, showing non-inferior pharmacokinetics, progression-free survival, and overall response rates versus the approved intravenous formulation, with successful on-body injector delivery in over 99% of administrations and no new safety signals. The European CHMP's positive opinion on March 27 endorsing the subcutaneous version for EU approval reinforces data strength, amid Sanofi’s established IV Sarclisa approvals in multiple myeloma indications. While inherent regulatory uncertainties persist, no advisory committee or red flags have emerged, driving optimism ahead of the imminent FDA decision.",
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