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BioNTech Says US FDA Lifts Partial Clinical Hold on Cancer Drug Trial
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BioNTech Says US FDA Lifts Partial Clinical Hold on Cancer Drug Trial
Aug 19, 2024 12:27 PM

03:02 PM EDT, 08/19/2024 (MT Newswires) -- BioNTech (BNTX) said Monday the US Food and Drug Administration lifted a partial clinical hold on an early-stage study of experimental cancer drug BNT326/YL202 in collaboration with MediLink Therapeutics.

The health regulator lifted the hold last week after the drugmakers included additional risk mitigation measures into the investigator brochure and consent for patients, BioNTech said.

BNT326/YL202 is an investigational drug for the treatment of certain non-small cell lung cancer and breast cancer.

BioNTech said it will re-initiate trial recruitment and that clinical development will focus on a specific dose threshold where "the safety profile was manageable and encouraging clinical activity was observed."

MediLink had previously observed treatment-related adverse events in participants, including a decrease in neutrophil count, BioNTech said.

Shares of BioNTech rose 6% in recent trading.

Price: 90.33, Change: +5.14, Percent Change: +6.03

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