FDA declines emergency authorization for Rigel Covid therapy

 - FDA declines to issue emergency use authorization for fostamatinib for the treatment of COVID-19 in hospitalized adults --

-- Rigel's COVID-19 program continues to actively enroll patients and will provide a robust data set to support the potential benefits of fostamatinib in COVID-19 --

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL), today announced that the U.S. Food and Drug Administration (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 (EUA) at this time. The FDA noted in their response that they remain committed to working with Rigel in the development of fostamatinib for COVID-19 as the Company is currently conducting a larger Phase 3 clinical trial evaluating fostamatinib in hospitalized patients with COVID-19.

"With new virus variants spreading and vaccination rates plateauing, there remains a need for therapies that can improve outcomes for hospitalized patients, particularly patients suffering from hyperinflammatory COVID-19-related complications," said Raul Rodriguez, president and CEO of Rigel. "The Rigel team continues to focus on enrolling our Phase 3 clinical trial, which we anticipate completing later this year, and we look forward to providing further safety and efficacy data from this larger, 308-patient trial of fostamatinib in COVID-19 patients. If this trial meets its endpoints, we plan to resubmit our EUA application with this additional data."

https://finance.yahoo.com/news/rigel-pharmaceuticals-provides-covid-19-113000708.html