Regulatory timelines shifted for Alzheimer’s therapy lecanemab (Leqembi) as the FDA delayed a decision on the company’s proposed subcutaneous route. Biogen and Eisai said the decision date was moved to August 24 after the agency requested additional information. The update comes as Biogen and Eisai pursue next-generation formulations intended to improve administration convenience and access. In parallel with this regulatory item, the same reporting segment noted other market events including a capital raise by Artiva and pricing activity by Pharvaris. For biotech industry teams, the practical takeaway is near-term uncertainty on formulation milestones and the knock-on effect on partnering, reimbursement planning, and launch sequencing—especially as subcutaneous convenience becomes a central lever for specialty neurodegenerative franchises.