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What will be the outcome of BioNTech's cancer drug trial by end of 2024?
5
Resolution / Starting Odds
Trial Resumed • 33%
Trial Terminated • 33%
Trial Modified • 34%
FDA announcements, BioNTech press releases
Story
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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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%
Significant survival improvement • 25%
Partial survival improvement • 25%
No significant change • 25%
Deterioration • 25%
Yes • 50%
No • 50%
Positive results • 25%
Negative results • 25%
Mixed results • 25%
No results published • 25%
Yes • 50%
No • 50%
Dose escalation • 25%
Safety assessment • 25%
Efficacy assessment • 25%
Trial termination • 25%
Yes • 50%
No • 50%
Positive results • 25%
Negative results • 25%
Mixed results • 25%
No results announced • 25%
Yes • 50%
No • 50%
Phase 2 • 25%
Phase 3 • 25%
Trial termination • 25%
No announcement • 25%
Yes • 50%
No • 50%
Increase by more than 20% • 25%
Increase by 10-20% • 25%
Increase by less than 10% • 25%
No increase or decrease • 25%