The trial is now only enrolling participants with moderate and severe neutropenia (ANC below 1,000 cells per microliter), an ANC level consistent with the company’s targeted patient population ...
XFOR READ THE FULL XFOR RESEARCH REPORT Business Update Full Enrollment of Phase 3 4WARD Trial Expected in 2H25 X4 ...
Phase 3 4WARD trial in chronic neutropenia now activated at ~90% of targeted trial sites; full enrollment expected in 3Q or 4Q 2025; top-line ...
The ANC testing is part of labeling, as the drug poses a risk for neutropenia. The REMS required that physicians and pharmacists be certified to prescribe and dispense the drug, which was ...
FDA still recommends that prescribers monitor patients’ ANC according to the monitoring frequencies described in the prescribing information. Information about severe neutropenia will remain in the ...
Prior to pharmacies dispensing clozapine, the FDA required patients to obtain and report a baseline absolute neutrophil count (ANC) blood test. In order to continue treatment, the ANC was to be ...
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