Apellis Aims New Pegcetacoplan Data At Market, Not Regulators
The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.
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The company plans to file the complement C5 inhibitor with the US FDA, but Apellis already has a drug pending for the indication.
One of two Phase III trials for pegcetacoplan in geographic atrophy previously failed, but 18-month data showed statistically significant and possibly accelerating improvement.