- Rigel Pharmaceuticals Inc RIGL Received guidance from the FDA review of its reanalysis of data from the FORWARD Phase 3 study of fostamatinib in warm autoimmune hemolytic anemia (wAIHA).
- Based on the guide, Rigel expects no file an additional marketing application for WAIHA, an autoimmune disease characterized by the premature destruction of healthy red blood cells (hemolysis).
- The company recently announced data from the FORWARD phase 3 study that failed to demonstrate statistical significance in the study’s primary efficacy endpoint of durable hemoglobin response total study population.
- Tavalisse/Tavlesse brand fostamatinib is approved for chronic immune thrombocytopenia (ITP), which can cause unusual bruising or bleeding due to an abnormally low platelet count.
- See also: Rigel Pharma Expands Blood Cancer Portfolio with Forma Therapeutics Licensing Pact.
- Rigel will continue to evaluate its options for the wAIHA program based on its full portfolio of development opportunities.
- Rigel also announced a 16% reduction in its workforce and the elimination of 30 positions, mainly in development and administration.
- As a result, Rigel expects to recognize a one-time severance payment of approximately $1.5 million in Q4 2022.
- This action is expected to result in reduced operating costs of between $7 million and $8 million per year beginning in 2023.
- Price promotion: RIGL shares are down 7.02% to $1.05 during the premarket session last check Tuesday.
© 2022 Benzinga.de. Benzinga does not provide investment advice. All rights reserved.
