Market Turmoil: Regeneron Takes a Hit After FDA's CRL
- June 27th, 2023
- 293 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.
THIS IS NOT A RECOMMENDATION TO BUY OR SELL ANY SECURITY OR DIGITAL ASSET. Please consult with a professional investment advisor before purchasing or selling any securities viewed on or mentioned herein. (Read Full Disclaimer)
Post Your Comments
Want To Find Some News?
Recent Posts
-
Micron Technology, Jabil, and Birkenstock Earnings Preview: What to Expect
December 15th, 2024Upcoming Earnings: Synopsys, AeroVironment, and nCino in Focus
December 01st, 2024Countdown to Earnings: Salesforce, Marvell Technology, and Okta Take the Stage
December 01st, 2024Fluence Energy, Agilent Technologies, and Woodward Earnings On Deck: A Preview
November 24th, 2024Earnings Preview: Walt Disney, Applied Materials, and Celcuity Take Center Stage
November 11th, 2024
Member Login