Rigel Provides Update on sNDA Program Plans for wAIHA Following FDA Comments
SOUTH SAN FRANCISCO, CA., October 10, 2022 /PRNewswire/ — Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has received guidance from the United States Food and Drug Administration (FDA) for the review of the new analysis by the data from the Phase 3 FORWARD trial of fostamatinib for the treatment of patients with autoimmune warm hemolytic anemia (wAIHA). Based on these guidelines, 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 full 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. Accordingly, Rigel expects to recognize a one-time severance charge of approximately $1.5 million in the fourth quarter of 2022. This measure is expected to reduce 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. Although we are disappointed not to filing an sNDA at this time, the steps we are taking are taking appropriate action as we focus Rigel on near-term opportunities in our fostamatinib, olutasidenib and IRAQ 1/4 programs,” said Raul RodriguezPresident and CEO of Rigel.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to the discovery, development and delivery of novel small molecule medicines that dramatically improve the lives of patients with blood disorders, cancer and immune diseases rare. Founded in 1996, Rigel is based in South of San Francisco, California. For more information about Rigel, the Company’s marketed product, and potential product pipeline, visit www.rigel.com.
This press release contains forward-looking statements regarding, among other things, Rigel’s wAIHA program, the timeline for the completion of the workforce reduction and the expected cost savings associated with the workforce reduction and the timing of such savings. All statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements may be identified by words such as “plan”, “potential”, “may”, “expect”, “will”, “believe”, “intend” and similar expressions by reference at future periods. Forward-looking statements are neither historical facts nor guarantees of future performance. Instead, they are based on Rigel’s current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, expected events and trends, the economy and other future conditions, and therefore inherently involve risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond our control. Accordingly, you should not rely on any such forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements due to such risks and uncertainties, which include, without limitation, the risks detailed from time to time in Rigel’s reports filed with the Securities and Exchange Commission. , including its quarterly report on Form 10-Q for the quarter ended June 30, 2022, and later filings. Any forward-looking statement we make in this press release is based solely on information currently available to us and speaks only as of the date on which it is made. Rigel undertakes no obligation to update any forward-looking statements, written or oral, which may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements contained herein, except as required by law.
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