Regeneron Pharmaceuticals expects a US decision on a higher-dose version of its blockbuster eye disease drug Eylea in the third quarter, much earlier than market expectations.
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, sending Regeneron's shares slumping over concerns of a delay. Regeneron and partner Bayer are betting on longer intervals between injections through the higher dose to win over patients. Regeneron reported adjusted profit of $10.24 per share for the second quarter, topping analysts' average estimates of $9.84, according to Refinitiv data.
US health regulators on Tuesday declined to approve a higher-dose version of Regeneron s drug Eylea for treatment of a disease that is leading cause of blindness among the elderly.
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