Reported Earlier, BioNTech SE Has Been Informed By Its Partner OncoC4 That The U.S. FDA Has Placed A Partial Clinical Hold On The Companies' Two-Stage, Open-Label, Randomized Phase 3 Trial, PRESERVE-003
Portfolio Pulse from Benzinga Newsdesk
BioNTech SE and OncoC4 have announced that the FDA has placed a partial clinical hold on their Phase 3 trial, PRESERVE-003, due to varying results in different NSCLC patient populations. Enrollment of new patients is paused, but current participants will continue treatment.
October 18, 2024 | 7:28 pm
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BioNTech SE's Phase 3 trial for NSCLC has been partially held by the FDA due to varying results in patient populations. Enrollment is paused, but treatment continues for current patients.
The FDA's partial hold on the trial indicates potential issues with the drug's efficacy across different patient populations, which could delay the trial's progress and impact BioNTech's stock negatively in the short term.
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IMPORTANCE 80
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