Rigel FORWARD Phase 3 trial of fostamatinib in wAIHA misses primary endpoint overall; positive regional signals seen

RIGEL PHARMACEUTICALS INC

Primary endpoint of durable hemoglobin response not met: fostamatinib 35.6% vs placebo 26.7% (p=0.398).
Post-hoc analysis: U.S./Canada/Australia/Western Europe showed significant benefit (36.0% vs 10.7%, p=0.03); Eastern Europe did not (35% vs 52.9%, p=0.304).
Safety profile consistent with prior data; most common AEs: diarrhea (26.7%), hypertension (24.4%), fatigue (15.6%).
Rigel plans further data analysis and discussion with FDA regarding regional differences.
71 of 90 patients (79%) enrolled in open-label extension study; data to be reported later.

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