Sponsor Overview
Explore verified public information about MacroGenics's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 2 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 1 supporting sources.
“MacroGenics may, on a case-by-case basis, consider requests by treating physicians to file an investigational new drug application for expanded access to MacroGenics investigational products in Phase 2 or Phase 3 of development and for MacroGenics to supply such investigational product. There is no guarantee of expanded access to an investigational product.”
Past EAPs on ClinicalTrials.gov
Score contribution: 40 — 2 supporting sources.
Conditions: Acute Myeloid Leukemia, AML, AML, Adult Recurrent
Conditions: West Nile Virus Infection
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria MacroGenics designs its clinical studies for development of new potential therapies to determine the safety and efficacy for medical use consistent with approval requirements of the US FDA and similar regulatory authorities in other countries. Treating physicians should consider approved therapies for a patient’s disease as well as on-going clinical studies before seeking expanded access use with an investigational agent. However, MacroGenics may, on a case-by-case basis, consider requests by treating physicians to file an investigational new drug application for expanded access to MacroGenics investigational products in Phase 2 or Phase 3 of development and for MacroGenics to supply such investigational product. There is no guarantee of expanded access to an investigational product. Available Therapies via Single-Patient EA At this time, MacroGenics is unable to make investigational products available outside a clinical trial.
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