Is Regeneron's Stock in Trouble After This FDA Rejection?
Regeneron Pharmaceuticals' (NASDAQ: REGN) sales growth has been lackluster in recent periods. The company is hoping that a higher-dose version of its eye medication Eylea could be a catalyst for driving sales higher in the future. However, last week the Food and Drug Administration (FDA) rejected the new drug application for it. Should investors be worried?
On June 27, Regeneron issued a press release stating that it received a complete response letter from the FDA, which indicates that the agency has not approved a new drug application for aflibercept 8 mg (the current approved version is for 2 mg). Regeneron says it was "solely due to an ongoing review of inspection findings at a third-party filler." The company says that there weren't any issues relating to labeling, efficacy, or safety.
Although the negative response from the FDA isn't great, Regeneron says it is going to work with the agency and the third-party filler to address the concerns. The positive takeaway from this is that the company doesn't need to do any additional trials. And without any significant safety or efficacy issues, this may only end up being a temporary delay in getting the higher-dose drug to market.
Source Fool.com
Regeneron Pharmaceuticals Inc. Aktie
Starke Kaufneigung bei Regeneron Pharmaceuticals Inc., mit mehr Buy- als Sell-Einschätzungen.
Ein positives, wenn auch bescheidenes, Potenzial für Regeneron Pharmaceuticals Inc. mit einem Kursziel von 1064 € im Vergleich zum aktuellen Kurs von 995.6 €.
