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Will there be further fatalities in BioNTech's cancer drug trial by end of 2024?
4
Resolution / Starting Odds
Yes • 50%
No • 50%
Clinical trial updates, BioNTech press releases
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FDA Places Partial Hold on BioNTech's Cancer Drug Trial After Three Fatalities
Jun 17, 2024, 01:05 PM
The U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on an early-stage study of BioNTech SE's experimental cancer drug, BNT326/YL202, which is being developed in partnership with MediLink Therapeutics. The hold was prompted by safety concerns, including the risk of exposing patients to unreasonable illness or injuries. The trial, which targets breast and lung cancer, has already seen three fatalities. The FDA's decision underscores the significant safety risks associated with the high doses used in the trial. The hold was documented in a 6-K filing.
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Yes • 50%
No • 50%
Successful with significant improvement in survival rates • 25%
Successful with moderate improvement in survival rates • 25%
No significant improvement in survival rates • 25%
Trial halted due to adverse effects • 25%
Yes • 50%
No • 50%
Significant survival improvement • 25%
Partial survival improvement • 25%
No significant change • 25%
Deterioration • 25%
Confirms higher SAE rate in early batches • 25%
Confirms no difference in SAE rates • 25%
Finds other contributing factors • 25%
Inconclusive results • 25%
Yes • 50%
No • 50%
Yes • 50%
No • 50%
Dose escalation • 25%
Safety assessment • 25%
Efficacy assessment • 25%
Trial termination • 25%
Significant tumor shrinkage • 25%
Improved survival rates • 25%
No significant effect • 25%
Other • 25%
Positive results • 25%
Negative results • 25%
Mixed results • 25%
No results published • 25%
Phase 2 • 25%
Phase 3 • 25%
Trial termination • 25%
No announcement • 25%