- The FDA has informed Rigel Pharmaceuticals Inc RIGL that data submitted in May from fostamatinib Phase 2 trial for COVID-19 is insufficient for an emergency use authorization (EUA).
- Rigel submitted clinical data from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib for hospitalized COVID-19 patients.
- The Company is currently conducting a larger Phase 3 trial evaluating fostamatinib in hospitalized COVID-19 patients.
- The 308-patient trial is expected to be complete later in 2021.
- Rigel said that if the Phase 3 trial meets its endpoints, it plans to resubmit the EUA application with this additional data.
- Price Action: RIGL shares are down 18.40% at $3.37 during the premarket session on the last check Friday.
- Related content: Benzinga's Full FDA Calendar.
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