The firm is preparing to submit supplemental NDAs for Vyondys 53 and Amondys 45 with results from a failed confirmatory trial and real-world data.
The groups are calling for genotype-informed prevention and treatment strategies, APOE stratification in clinical trials, and related public policies.
After a meeting with the FDA, the company believes the agency is aligned with its development plan to start a Phase III registrational trial in CLDN 18.2-, PD-L1-positive tumors.
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