Regeneron expects FDA decision on high-dose eye drug this year, shares jump


Regeneron expects FDA decision on high-dose eye drug this year, shares jump

Aug 3 (Reuters) – Regeneron Pharmaceuticals (REGN.O) 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 5% higher in premarket trading on Thursday.

The U.S. Food and Drug Administration declined to approve a higher-dose version of Eylea in June following an inspection at third-party manufacturer Catalent (CTLT.N), sending Regeneron’s shares slumping over concerns of a delay.

The drugmaker said on Thursday it expects to submit some manufacturing data required by the FDA by mid-August, and expects the regulator to make a decision in the third quarter.

“This is a big positive as many investors were concerned that timeline could slip and a potential class 2 re-submission could potentially move the approval into 2024,” said Wells Fargo 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 (ROG.S) Vabysmo.

Regeneron and partner Bayer (BAYGn.DE) 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 (SASY.PA), surged 33% to $2.79 billion during the quarter. Sales of the treatment, which was approved in 2017, has helped mitigate the decline in sales of Eylea.

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

Reporting by Khushi Mandowara in Bengaluru; Editing by Sriraj Kalluvila
Source: Reuters