{
  "question_id": "W236",
  "slug": "fda-approves-ai-designed-drug",
  "title": "FDA approves a drug credited to AI de novo design",
  "type": "binary",
  "resolution": {
    "levels": [],
    "values": [],
    "annotations": []
  },
  "forecasts": [
    {
      "question_id": "W236",
      "forecast_date": "2026-09-20",
      "evidence_cutoff": "2026-09-20",
      "method": "wide-v2",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "I count AI-generated modifications that produce a new therapeutic structure, sequence, or construct even when based on known material, but require explicit product-specific generation credit rather than treating AI scoring, neoantigen selection, or generic optimization labels alone as sufficient.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.002
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.014
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.1224
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.1444
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.1743
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.2115
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.2351
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.2619
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.2914
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.3233
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.3504
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.3829
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.4322
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.489
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.5605
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.6397
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.7117
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.7607
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.7894
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.8147
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.8369
        }
      ],
      "passes": []
    },
    {
      "question_id": "W236",
      "forecast_date": "2026-09-27",
      "evidence_cutoff": "2026-09-27",
      "method": "wide-v2",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "AI generation of a new optimized structure or engineered sequence can qualify even when it uses existing scaffolds or fragments, but candidate or neoantigen selection alone does not establish generation of the therapeutic design.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.001
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.005
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.0398
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.059
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.0873
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.1329
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.1589
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.1841
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.2168
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.2598
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.308
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.3633
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.4206
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.4786
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.5411
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.6008
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.6567
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.7047
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.7461
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.7816
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.8122
        }
      ],
      "passes": []
    },
    {
      "question_id": "W236",
      "forecast_date": "2026-10-02",
      "evidence_cutoff": "2026-10-02",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": "AI used only to score/select (FEP scoring, virtual screening, MD-based 'motion' design, ADMET prediction, neoantigen selection) does not count; an AI platform generating a new sequence or structure (including generative redesign of a reference antibody, as Generate describes for GB-0895) counts if the developer explicitly says so in a developer-authored source dated on or after 2026-09-16.",
      "summary": null,
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-09-30",
          "p_yes": 0.003
        },
        {
          "period_end": "2026-12-31",
          "p_yes": 0.008
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.044
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.055
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.077
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.099
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.12
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.136
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.147
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.156
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.166
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.177
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.189
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.202
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.219
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.242
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.278
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.328
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.392
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.448
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.495
        }
      ],
      "passes": []
    },
    {
      "question_id": "W236",
      "forecast_date": "2026-10-09",
      "evidence_cutoff": "2026-10-09",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": "No FDA-approved medicine yet has a developer saying AI generated it. The most likely first case is Generate Biomedicines' AI-engineered asthma antibody, golukibart. Its late-stage trial results are due around early 2029, which could lead to approval in 2030–2031. Two products that may be approved sooner probably won't count: Takeda's psoriasis pill (decision due early 2027) and Moderna and Merck's personalized cancer vaccine. Their developers don't say AI generated the drug. Golukibart's trial results matter most.",
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-12-31",
          "p_yes": 0.002
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.011
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.021
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.036
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.05
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.062
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.072
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.08
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.087
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.1
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.112
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.125
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.14
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.167
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.207
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.267
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.341
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.412
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.473
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.526
        },
        {
          "period_end": "2031-12-31",
          "p_yes": 0.577
        }
      ],
      "passes": []
    },
    {
      "question_id": "W236",
      "forecast_date": "2026-10-16",
      "evidence_cutoff": "2026-10-16",
      "method": "wide-v2.1",
      "opened": "2026-09-16",
      "linked_questions": [],
      "reading_adopted": null,
      "summary": "I put the chance of a qualifying approval at about 1% by end of 2026, 8% by end of 2027, 38% by end of 2030 and 60% by end of 2031. No FDA-approved drug yet has a developer saying AI created its structure. The approvals due soonest, Takeda's psoriasis pill (early 2027) and Moderna and Merck's melanoma vaccine, used AI to screen or select, which doesn't count. The likeliest qualifier is Generate Biomedicines' AI-engineered asthma antibody, possibly approved in 2030–31. If its late-stage trials fail, this forecast drops most.",
      "ambiguities": [],
      "key_drivers": [],
      "would_update_on": [],
      "forecasts": [
        {
          "period_end": "2026-12-31",
          "p_yes": 0.007
        },
        {
          "period_end": "2027-03-31",
          "p_yes": 0.029
        },
        {
          "period_end": "2027-06-30",
          "p_yes": 0.04
        },
        {
          "period_end": "2027-09-30",
          "p_yes": 0.057
        },
        {
          "period_end": "2027-12-31",
          "p_yes": 0.075
        },
        {
          "period_end": "2028-03-31",
          "p_yes": 0.089
        },
        {
          "period_end": "2028-06-30",
          "p_yes": 0.101
        },
        {
          "period_end": "2028-09-30",
          "p_yes": 0.112
        },
        {
          "period_end": "2028-12-31",
          "p_yes": 0.123
        },
        {
          "period_end": "2029-03-31",
          "p_yes": 0.138
        },
        {
          "period_end": "2029-06-30",
          "p_yes": 0.152
        },
        {
          "period_end": "2029-09-30",
          "p_yes": 0.171
        },
        {
          "period_end": "2029-12-31",
          "p_yes": 0.203
        },
        {
          "period_end": "2030-03-31",
          "p_yes": 0.242
        },
        {
          "period_end": "2030-06-30",
          "p_yes": 0.282
        },
        {
          "period_end": "2030-09-30",
          "p_yes": 0.327
        },
        {
          "period_end": "2030-12-31",
          "p_yes": 0.38
        },
        {
          "period_end": "2031-03-31",
          "p_yes": 0.443
        },
        {
          "period_end": "2031-06-30",
          "p_yes": 0.503
        },
        {
          "period_end": "2031-09-30",
          "p_yes": 0.556
        },
        {
          "period_end": "2031-12-31",
          "p_yes": 0.6
        }
      ],
      "passes": []
    }
  ],
  "declined": []
}