Earlier today, MorphoSys AG MOR and its partner Roche Holdings AG RHHBY reported disappointing results from gantenerumab studies in mild cognitive impairment (MCI) due to Alzheimer’s and mild Alzheimer’s dementia.
Needham writes that with both GRADUATE studies failing to meet the primary endpoint, it removes a potential competitor for Eisai Ltd ESALY and Biogen Inc’s BIIB lecanemab.
Roche’s data was much awaited after Biogen and Eisai said the global Phase 3 confirmatory study, “Clarity AD,” of lecanemab met the primary endpoint and all key secondary endpoints with highly statistically significant results.
However, heading into 2023, the ability of Eisai/BIIB to persuade CMS to reconsider the current National coverage determinations (NCD) and secure full reimbursement for lecanemab is the biggest debate on the stock.
The recently released data, both Eisai and Biogen, have postured greater confidence that the CLARITY results can be sufficient for reconsideration.
At face value, CMS’s bar for clinically meaningful evidence is high. It will look across the entire Aβ class for clinical evidence, which may require positive evidence across multiple Aβ products, and for which today’s results are on gantenerumab only serve to complicate the body of evidence.
Regarding the next data readouts, Needham looks for any incremental details at CTAD for lecanemab (Nov. 29) and gantenerumab (Nov. 30).
Price Action: BIIB shares are up 4.84% at $303.47 on the last check Monday.
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