PRNewsWire
13 Jul 2026, 04:02 UTC · 2h ago
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Clinical data show that the Leqembi subcutaneous autoinjector (SC-AI) provides efficacy and safety comparable to the existing intravenous (IV) formulation. — Comparable efficacy with a more convenient delivery method significantly lowers barriers to patient adoption and expands the addressable market.
+0.60The US FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) for a subcutaneous starting dose, with a PDUFA date of August 24, 2026. — A confirmed regulatory decision date for a simplified initiation process provides a concrete near-term catalyst for stock valuation.
+0.50The subcutaneous formulation enables a fully subcutaneous treatment pathway from initiation through maintenance, allowing for at-home administration. — Moving treatment from clinics to the home reduces healthcare infrastructure costs and increases patient adherence.
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Regulatory applications for the subcutaneous formulation have been accepted for priority review in China and submitted in Japan. — Expansion into major Asian markets with a preferred delivery method supports long-term global revenue growth.
+0.30Which stocks this story touches
Positive data presented at AAIC supporting the efficacy and safety of the Leqembi subcutaneous autoinjector.
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