Will the US, UK or EU approve a gene editing therapy for a new condition during 2026?
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Manifold MarketsKurallar
If, at any point between January 1st, 2026, 00h00 UTC, and December 31st, 2026, 25H59 UTC, the US Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), or the European Commission authorizes the use or sale of a therapy whose primary mechanism is directly editing the patient's genomic DNA, for any human condition other than sickle cell disease and beta thalassemia, this market will resolve to "Yes".
- Otherwise, it will resolve to "No".
- The Primary Designated Source is the official approval database of whichever regulator is involved — FDA Drug Approvals (fda.gov), MHRA product information (gov.uk/mhra), or the European Commission Union Register of medicinal products (ec.europa.eu/health/documents/community-register).
- Approvals of new indications, formulations, or labels for therapies already approved for sickle cell disease or beta thalassemia (e.g., exa-cel / Casgevy expansions) do not count; only therapies addressing a different human condition.
- Conditional, accelerated, or emergency authorizations from the named regulators docount for this market’s purposes.
- Therapy mechanisms that do not directly edit the patient's genomic DNA in vivo or ex vivo (e.g., mRNA therapies, gene replacement via AAV without genomic editing) do not count.
