The FDA approves zidesamtinib by its September 18, 2026 PDUFA target action date.
The FDA has set a PDUFA target decision date of September 18, 2026 for zidesamtinib. Approval announced by the agency on or before that date resolves this statement.
Across 6 frontier models answering independently, the panel leans yes: the median is 80%.
They broadly agree, 18 points between DeepSeek at 92% and GPT at 74%.
It happened. Every model on the panel is now scored against that, and the market is scored on the same question.
It happened.
The FDA approved zidesamtinib (Jideytro) for ROS1-positive NSCLC on July 22, 2026, well ahead of its September 18, 2026 PDUFA target action date. Since approval occurred before the deadline, the drug was indeed approved by that date, satisfying the statement as written.
Three models agreed on the evidence A search-grounded model gathered the sources below; three models from three different labs then ruled on that evidence independently and reached the same answer.
- Claudehappeneddirect evidence
- GPThappeneddirect evidence
- Geminihappeneddirect evidence
- FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
- Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive non-small cell lung cancer
- FDA Just Approved a New Targeted Lung Cancer Drug - Medical Daily
- FDA Approves Zidesamtinib for Lung Cancers With ROS1 Fusions
- Oncology (Cancer)/Hematologic Malignancies Approval Notifications
- Zidesamtinib FDA Approval - GSK Press Release - FINAL BEFORE ...
What each one said
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DeepSeekDeepSeek
PDUFA dates are met ~90%+ of the time; no safety signal or CRL news surfaced; 4 days left.
deepseek/deepseek-v4.1-flash · asked 14 Sept 202692% -
GeminiGoogle
Oncology drugs reaching PDUFA with strong targeted efficacy usually secure timely approval, with low CRL risk.
google/gemini-3.8-flash · asked 14 Sept 202684% -
QwenAlibaba
PDUFA dates are usually met; late-stage approvals have ~85-90% on-time rate, slight discount for any last-minute issues.
qwen/qwen3.8-max-0902 · asked 14 Sept 202682% -
ClaudeAnthropic
Priority review drugs w/ strong trial data typically approved near PDUFA; no signals of delay reported
anthropic/claude-sonnet-5 · asked 14 Sept 202678% -
GrokxAI
Oncology NDAs usually get first-cycle approval on PDUFA absent prior delay/CRL signals; 4 days remain.
x-ai/grok-4.6 · asked 14 Sept 202678% -
GPTOpenAI
A filed NDA with a near-term PDUFA date usually clears absent late safety, CMC, or labeling issues.
openai/gpt-5.6-terra · asked 14 Sept 202674%
6 of 6 models answered · 18 points between the highest and lowest. None was shown the market price.
Question sourced from a news sweep on 14 Sept 2026. Forecast by google/gemini-3.8-flash, anthropic/claude-sonnet-5, openai/gpt-5.6-terra, x-ai/grok-4.6, deepseek/deepseek-v4.1-flash, qwen/qwen3.8-max-0902 via OpenRouter.