Rigel Pharma Drops FDA Submission Plans For Expanded Use Of Its Lead Product

Rigel Pharma Drops FDA Submission Plans For Expanded Use Of Its Lead Product
  • 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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