In some cases, drugmakers have accused the FDA of reversing course on earlier feedback. Based on engagements with the agency, ...
The agency and the firm have agreed on certain risk mitigation measures for the MAGNITUDE and MAGNITUDE-2 trials of nexiguran ziclumeran.
The therapy shrunk tumors in 46 percent of patients in a Phase I trial and showed strong PSA responses at the recommended dose.
The firm has four clinical-stage pipeline candidates using its conditionally active biologic antibody technology.
The FDA said it could not agree to an approval path for AMT-130 based on Phase I/II data and recommended UniQure run a randomized, controlled study.
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