Full Press Release Details
Provides Update on Plans for sNDA for wAIHA Program Following FDA Feedback
--Announces Workforce Reduction--
SOUTH SAN FRANCISCO, Calif., October 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,
"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
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company
dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with hematologic
disorders, cancer, and rare immune diseases. Founded in 1996, Rigel is based in South San Francisco, California. For more information
on Rigel, the Company's marketed product and pipeline of potential products, visit www.rigel.com.
Forward-Looking Statements
This press release contains forward-looking statements relating
to, among other things, Rigel's wAIHA program, the timing for completion of the workforce reduction and the expected cost savings
associated with workforce reduction and the timing of any such savings. Any statements contained in this press release that are not statements
of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "plan",
"potential", "may", "expect", "will", "believe", "intend" and similar
expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances 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, anticipated events and trends, the economy and other future conditions, and hence they inherently involve
significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control.
Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially
from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation,
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 subsequent filings. Any forward-looking statement made by us in this press release
is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any
obligation to update forward-looking statements, whether written or oral, that 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 publicly any updates
or revisions to any forward-looking statements contained herein, except as required by law.
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Rigel Pharmaceuticals, Inc.