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Rigel Reaches Agreement With FDA On Study Design Of Phase 3 Trial Of Fostamatinib

Rigel Pharmaceuticals, Inc. (RIGL) said it has reached agreement with the FDA on the final design of its FORWARD study, a pivotal phase 3 clinical trial of fostamatinib disodium hexahydrate (fostamatinib) in warm autoimmune hemolytic anemia. The company noted that FDA agreed to Rigel's proposed durable response measure for the primary efficacy endpoint as well as the inclusion of additional secondary endpoints.

"Our conversations with the FDA have enabled us to finalize the primary efficacy endpoint for the only ongoing phase 3 trial in warm AIHA, a condition for which there is no approved therapy," said Raul Rodriguez, Rigel's CEO.

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