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The FDA's Priority Review generally signals strong potential for approval, influencing investor confidence. Previous approvals in similar contexts have led to significant price increases.
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FDA granted Priority Review for APLS's Empaveli for C3G and IC-MPGN. Phase 3 VALIANT results showed significant proteinuria reduction in treated patients. Empaveli achieved favorable safety profile consistent with established data. Market size for C3G could be larger post-approval of Empaveli. APLS stock rose 8.05% following the FDA news.
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