Prediction
Answer Options
Daraxonrasib is a RAS inhibitor drug developed by Revolution Medicines and currently in trial to treat RAS-mutated cancers. This market will resolve to "Yes" if the US Food and Drug Administration (FDA) grants a full or conditional approval for a drug product whose active ingredient is Revolution Medicines' daraxonrasib, including under any brand name or identifier, for any use between market creation and 05:59 CET/CEST on January 1, 2027. Otherwise, this market will resolve to "No". An approval is defined as follows. For new drugs, it is the FDA's issuance of an approval letter for a New Drug Application (NDA) or Biologics License Application (BLA). For already-marketed drugs seeking new indications, it is FDA approval of a supplemental NDA (sNDA) or supplemental BLA (sBLA) for the specific indication referenced. For generic drugs, it is FDA approval of an Abbreviated New Drug Application (ANDA). For biosimilars, it is FDA approval of a 351(k) application. The following constitute qualifying approvals: standard approval based on clinical benefit, accelerated approval based on surrogate endpoints, approval with a Risk Evaluation and Mitigation Strategy (REMS), and approval with restricted distribution or indication limitations. Compassionate use and expanded access programmes are excluded. 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, extensions of Prescription Drug User Fee Amendments dates, approval for compassionate use or expanded access programmes only, approval only for export or for use outside the United States, Emergency Use Authorisation (EUA) without full approval, and Complete Response Letters (CRLs) indicating the application cannot be approved in its current form. If the listed drug is approved within this market's timeframe, this market will resolve to "Yes", regardless of any 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. A consensus of credible reporting will also be used.
Reported by Versus Markets