Rigel’s Tavalisse Hits Pothole In Label Expansion For Hemolytic Anemia

Tavalisse misses the primary endpoint in a 90-patient Phase III trial in warm autoimmune hemolytic anemia, but Rigel contends a high placebo response in Eastern Europe confounded the results.

Rigel's label-expansion plans for Tavalisse hindered by FORWARD data

Rigel Pharmaceuticals, Inc. is working to expand the label for Tavalisse, its lone commercial product, beyond the initial indication of immune thrombocytopenia (ITP), but suffered a major setback on 8 June when it reported that the Phase III FORWARD study in warm autoimmune hemolytic anemia (wAIHA) missed its primary endpoint. Executives of the San Francisco area biotech told an investor call that a high placebo response in Eastern European patients confounded the results, which showed efficacy in other geographies.

This analysis did not appear to comfort shareholders. Rigel’s share price tanked below the $1 threshold on the news and did not recover in trading on 8 June, finishing the day down 60% to $0.70

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