Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) shares fell after the FDA issued a Complete Response Letter (CRL) for aflibercept 8 mg Biologics License application due to an ongoing review of inspection findings at a third-party filler.
What To Know: No issues were identified with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug substance manufacturing, and no additional clinical data or trials have been requested.
Following a news halt, Regeneron shares resumed trade at 3:15 pm EST on Tuesday at which time the shares proceeded to plummet over 7%.
The company said it is ‘committed to working closely with the FDA and the third-party filler to bring aflibercept 8 mg to patients with wAMD, DME and DR as quickly as possible.’
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REGN Price Action: Shares of REGN were down 8.21% at $720.00 at the time of publication, according to Benzinga Pro.
Image by Michal Jarmoluk from Pixabay
