Market Turmoil: Regeneron Takes a Hit After FDA's CRL
- June 27th, 2023
- 499 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
-
Treasury Targets Global Scam Networks and the Corporate Infrastructure That Enables Them
November 06th, 2026FDA Grants Accelerated Approval to a New Treatment for Head and Neck Squamous Cell Carcinoma
November 05th, 2026New Details Emerge in Amazon Ads Auction-Rigging Case
November 05th, 2026November 02nd, 2026
Member Login