Rigel Provides Update On Plans For Supplemental New Drug Application For Warm Autoimmune Hemolytic Anemia Program Following FDA Feedback

–Announces Workforce Reduction–

–Announces Workforce Reduction–

SOUTH SAN FRANCISCO, Calif., Oct. 10, 2022 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (NASDAQ:RIGL) today announced that it has received guidance from the U.S. Food and Drug Administration (FDA)’s review of the Company’s re-analysis of data from the FORWARD Phase 3 trial of fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA). Based on this guidance, Rigel does not expect to file a supplemental New Drug Application (sNDA) for this indication at this time. Rigel will continue to explore its options for the wAIHA program in relation to its complete portfolio of development opportunities.

Rigel also announced today that it will reduce its workforce by 16%, resulting in the elimination of 30 positions primarily in development and administration. As a result, Rigel expects that it will recognize a one-time cash severance-related charge of approximately $1.5 million in the fourth quarter of 2022. This measure is expected to provide reduced operating expenses ranging from $7-$8 million annually, starting in 2023.

“I would like to express my gratitude to the Rigel team, clinicians and especially the patients who participated in our FORWARD trial for their contributions to advancing potential new therapies in wAIHA. While we are disappointed to not file an sNDA at this time, the steps we are taking are appropriate actions as we focus Rigel on near-term opportunities across our fostamatinib, olutasidenib, and IRAK 1/4 programs,” said Raul Rodriguez, president and chief executive officer of Rigel.

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