Rigel: FDA Declines Emergency-Use Authorization for Fostamatinib
August 13 2021 - 8:12AM
Dow Jones News
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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