Rigel Pharma Drops FDA Submission Plans For Expanded Use Of Its Lead Product - Rigel Pharmaceuticals (NASDAQ:RIGL)

Rigel Pharmaceuticals Inc RIGL received guidance from the FDA's review of its re-analysis of data from the FORWARD Phase 3 trial of fostamatinib for warm autoimmune hemolytic anemia (wAIHA).
Based on the guidance, Rigel does not expect to file a supplemental marketing application for wAIHA, an autoimmune disorder characterized by the premature destruction of healthy red blood cells (hemolysis).
The company recently announced data from the FORWARD Phase 3 trial that did not demonstrate statistical significance in the primary efficacy endpoint of durable hemoglobin response in the overall study population.
Fostamatinib branded as Tavalisse / Tavlesse is approved for chronic immune thrombocytopenia (ITP), which may cause unusual bruising or bleeding due to an abnormally low number of platelets.
Also see: Rigel Pharma Expands Blood Cancer Portfolio With Forma Therapeutics Licensing Pact.
Rigel will continue to explore its options for the wAIHA program concerning its complete portfolio of development opportunities.
Rigel also announced cutting its workforce by 16%, eliminating 30 positions, primarily in development and administration.
As a result, Rigel expects to recognize a one-time cash severance-related charge of approximately $1.5 million in Q4 of 2022.
This measure is expected to provide reduced operating expenses ranging from $7-$8 million annually, starting in 2023.
Price Action: RIGL shares are down 7.02% at $1.05 during the premarket session on the last check Tuesday.

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