2023-06-28 10:42:32 ET
- Catalent ( NYSE: CTLT ) shares extended a four-day decline on Wednesday after confirming that it was the third-party manufacturer linked to the recent FDA rejection of high-dose Eylea developed by Regeneron ( REGN ).
- The shares of the contract manufacturer tumbled on Tuesday alongside Regeneron ( REGN ) on the news that the FDA rejected the 8 mg version of the blockbuster eye disease therapy known as aflibercept due to findings at a third-party filler.
- "Catalent’s Bloomington facility recently underwent a scheduled pre-approval inspection for aflibercept 8 mg., during which the regulator made three observations ," the contract manufacturer said in a statement.
- According to Regeneron ( REGN ), which markets Eylea globally with Bayer AG ( OTCPK:BAYZF ) ( OTCPK:BAYRY ), the FDA has not identified any concerns regarding the treatment’s clinical efficacy or safety and has not requested additional clinical data or trials.
- The decision prompted Canaccord Genuity to downgrade Regeneron ( REGN ), citing a longer than expected timeline for its approval.
For further details see:
Catalent confirmed as manufacturer of Regeneron’s high-dose Eylea rejected by FDA