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Rigel : FDA Didn't Issue EUA For Fostamatinib For Treatment Of COVID-19 In Hospitalized Adults

Rigel Pharmaceuticals Inc. (RIGL) said Friday that the U.S. Food and Drug Administration did not issue emergency use authorization for fostamatinib for the treatment of COVID-19 in hospitalized adults, due to insufficient clinical data.

In Friday pre-market trade, RIGL was trading at $3.60, down $0.53 or 12.83%.

"The FDA has informed the company that clinical data submitted in late-May from a 59-patient NIH/NHLBI-sponsored Phase 2 trial of fostamatinib to treat hospitalized patients suffering from COVID-19 are insufficient for an emergency use authorization at this time," Rigel said in a statement.

However, Rigel said it continues to focus on enrolling its Phase 3 clinical trial, which it anticipates completing later this year. The trial is evaluating fostamatinib in hospitalized patients with COVID-19.

The company looks forward to providing further safety and efficacy data from the larger, 308-patient trial of fostamatinib in COVID-19 patients. If this trial meets its endpoints, the company plans to resubmit its mergency use authorization application with the additional data.

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