Rigel: FDA Declines Emergency-Use Authorization for Fostamatinib

By Colin Kellaher

Rigel Pharmaceuticals Inc. on Friday said the U.S. Food and Drug Administration declined the company's request for an emergency-use authorization for fostamatinib to treat hospitalized patients suffering from Covid-19.

The South San Francisco, Calif., biotechnology company said the agency determined that clinical data it submitted in late May from a phase 2 study are insufficient to support the authorization at this time.

Rigel said the FDA noted that it remains committed to working with the company in developing fostamatinib for Covid-19.

Rigel is currently conducting a larger Phase 3 trial of fostamatinib in hospitalized Covid-19 patients, and the company said it would resubmit its application for an emergency-use authorization if that study meets its primary endpoints.

Shares of Rigel, which closed Thursday at $4.13, fell nearly 10% in premarket trading Friday.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

August 13, 2021 08:00 ET (12:00 GMT)

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