U.S. FDA Issues Complete Response Letter for [Vic-]Trastuzumab Duocarmazine

While Byondis is disappointed with this outcome, the company remains optimistic about SYD985’s potential. “We continue to believe that SYD985 can present a meaningful treatment option for patients living with HER2-positive metastatic breast cancer,” said Byondis CEO Marco Timmers, Ph.D. “We appreciate the FDA’s guidance and support and will carefully evaluate the complete response letter and consider potential next steps.”

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