Regeneron expects FDA decision on higher-dose Eylea this year

By Khushi Mandowara

(Reuters) -Regeneron Pharmaceuticals expects a U.S. decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations, sending its shares up 5% on Thursday.

The U.S. Food and Drug Administration declined to approve the higher-dose version in June following an inspection at third-party manufacturer Catalent (NYSE:).

Regeneron (NASDAQ:) said it has been submitting manufacturing data required by the FDA on a rolling basis, and expects to finish the submissions by mid-August.

It expects the FDA to decide on the drug in the third quarter, compared with expectations of a review next year.

Regeneron said the higher-dose Eylea was manufactured on the same line as pozelimab, its experimental drug being reviewed to treat a rare blood disease. A decision on that drug is due by Aug. 20.

“We think approval of pozelimab would be a huge positive for (high dose) Eylea time lines,” said Wells Fargo (NYSE:) analyst Mohit Bansal.

Analysts have said an approval of the higher-dose version of the eye drug could provide a defense against rivals such as Roche’s Vabysmo.

Regeneron and partner Bayer (OTC:) are betting on longer intervals between injections through the higher dose to win over patients.

U.S. sales of Eylea fell 7% to $1.50 billion in the second quarter, but came in slightly above estimates of $1.48 billion.

Meanwhile, sales of eczema drug Dupixent, recorded by partner Sanofi (NASDAQ:), surged 33% to $2.79 billion during the quarter. Sales of the treatment, which was approved in 2017, have helped mitigate the decline in sales of Eylea.

Regeneron reported an adjusted profit of $10.24 per share for the quarter, topping analysts’ estimates of $9.84, according to Refinitiv data.