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What milestone will BioNTech's BNT326/YL202 trial reach by end of 2024?
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Resolution / Starting Odds
Dose escalation • 25%
Safety assessment • 25%
Efficacy assessment • 25%
Trial termination • 25%
Official announcements from BioNTech, MediLink Therapeutics, or the FDA
Story
FDA Lifts Hold on BioNTech's BNT326/YL202 Cancer Drug Trial
Aug 19, 2024, 11:40 AM
BioNTech announced that the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on its experimental cancer drug trial. The trial involves BNT326/YL202, an anti-HER3 antibody-drug conjugate (ADC), developed in partnership with MediLink Therapeutics. The FDA's decision allows the companies to restart the phase 1 trial, with the stipulation that only lower doses will be used.
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Trial Resumed • 33%
Trial Terminated • 33%
Trial Modified • 34%
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%
Hold Lifted • 33%
Hold Extended • 33%
New Restrictions • 34%
Significant Improvement • 33%
No Change • 33%
Significant Adverse Effects • 34%
Significant survival improvement • 25%
Partial survival improvement • 25%
No significant change • 25%
Deterioration • 25%
Yes • 50%
No • 50%
Yes • 50%
No • 50%
Phase 1 • 25%
Phase 2 • 25%
Phase 3 • 25%
Phase 4 • 25%
Positive results • 25%
Negative results • 25%
Mixed results • 25%
No results announced • 25%
Phase II trial completion • 25%
Phase III trial commencement • 25%
FDA approval • 25%
None of the above • 25%
Completion of Phase 3 trial • 25%
FDA approval • 25%
Partnership with another company • 25%
No major milestone announced • 25%