Market Turmoil: Regeneron Takes a Hit After FDA's CRL
- June 27th, 2023
- 380 views
Shares of Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) tumbled more than 8% during intraday trading in response to the company receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA).
The CRL was issued for the Biologics License Application (BLA) of aflibercept 8 mg, intended for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The FDA's decision was based on an ongoing review of inspection findings at a third-party filler, unrelated to any concerns about the drug's clinical efficacy, safety, trial design, labeling, or manufacturing.
According to Regeneron, no further clinical data or trials have been requested and it remains committed to collaborating closely with the FDA and the third-party filler to expedite the availability of aflibercept 8 mg for patients with wAMD, DME, and DR.
Currently, $REGN is trading at $720.00, reflecting a decline of $64.38 (8.21%) following the announcement.
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