The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.
Current status: ENROLLING BY INVITATION.
Rigel Pharmaceuticals (RIGL) is the sponsoring company for this trial. BiotechSign currently grades this company D (40/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.