- Eisai Limited ESALY and partner Biogen Inc BIIB presented detailed data from the positive Phase 3 CLARITY-AD study of lecanemab in early Alzheimer's disease (AD).
- William Blair analyst says that overall the data is robust and of high impact to both the AD clinician community and regulators and CMS as the next three to nine months carry critical regulatory and reimbursement milestones for the anti-amyloid therapy drug class.
- Related: Open Questions On Safety Lingers After Eisai-Biogen's Detailed Lecanemab Data For Alzheimer's.
- SVB Leerink writes that everything from the presentation supports the positive view of this product. Based on the positive CLARITY-AD data, the analyst believes lecanemab should get regular approval.
- However, SVB would still expect key investor debates to continue in the coming months, including clinical meaningfulness of lecanemab's treatment effect, long-term risk/benefits given the ARIA adverse events, and if and when CMS could expand its coverage for the anti-Abeta class.
- Needham notes that CLARITY AD results alone may not be sufficient for CMS reconsideration for full coverage. While the analyst believes the CLARITY AD data looks incrementally better following the full data presentation, it doesn't believe this data sufficiently moves the needle.
- Price Action: BIIB shares are up 3.69% at $302.16 on the last check Wednesday.
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