BioNTech Partner Medilink Therapeutics Says FDA Has Placed Partial Clinical Hold On Phase 1 Trial Of BNT326/YL202 For Heavily Pre-Treated Advanced Or Metastatic EGFR-Mutated Non-small Cell Lung Cancer Or HR+/HER2-Negative Breast Cancer-6K
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The FDA has placed a partial clinical hold on the Phase 1 trial of BNT326/YL202, a treatment for advanced or metastatic EGFR-mutated non-small cell lung cancer or HR+/HER2-negative breast cancer, due to safety concerns. This affects the enrollment of new patients in the U.S. BioNTech's partner, Medilink Therapeutics, must address these concerns by reviewing clinical and safety data and providing additional information to the FDA.
June 17, 2024 | 11:27 am
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The FDA has placed a partial clinical hold on BioNTech's Phase 1 trial for BNT326/YL202 due to safety concerns, affecting the enrollment of new patients in the U.S. BioNTech and its partner Medilink Therapeutics must address these concerns by reviewing clinical and safety data and providing additional information to the FDA.
The partial clinical hold by the FDA on the Phase 1 trial of BNT326/YL202 due to safety concerns is likely to negatively impact BioNTech's stock in the short term. The hold affects the enrollment of new patients in the U.S., and BioNTech must address the FDA's concerns by reviewing clinical and safety data and providing additional information.
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