FDA Accepts for Priority Review Biologics License Application for REGN-EB3 to Treat Ebola
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: PR Newswire
TARRYTOWN, N.Y., April 16, 2020 /PRNewswire/ -- REGN-EB3 developed via same rapid response platform currently being leveraged to develop novel COVID-19 antibody therapyRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a new Biologics License Application (BLA) for REGN-EB3, an investigational triple antibody cocktail treatment for Ebola virus infection. The target action date for the FDA decision is October 25, 2020. The REGN-EB3 BLA is supported by data from the randomized, controlled PALM clinical trial conducted in the Democratic Republic of Congo. In August 2019, the trial was stopped early when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm, ZMapp. REGN-EB3 demonstrated superior efficacy compared to ZMapp across multiple measures, including reduced mortality and fewer days until the Ebola virus was
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REGN
Earnings
- 10/31/24 - Beat
REGN
Sec Filings
- 11/12/24 - Form 4
- 11/5/24 - Form 4
- 11/1/24 - Form 144
- REGN's page on the SEC website