The groups are calling for genotype-informed prevention and treatment strategies, APOE stratification in clinical trials, and related public policies.
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.
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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