By Senad Karaahmetovic
Biogen (NASDAQ:BIIB) yesterday presented detailed results from the Ph3 Clarity AD confirmatory trial.
According to the company, Lecanemab "reduced markers of amyloid in early Alzheimer's disease and resulted in moderately less decline on measures of cognition and function than placebo at 18 months but was associated with adverse events."
Here's what 5 Biogen analysts had to stay about yesterday's presentation and the impact on Biogen stock.
Stifel analysts: "We're reiterating our Buy rating on Biogen on the full Lecanemab CTAD presentation and NEJM publication which we believe is reaffirming to the positive top-line result. Overall, there was nothing odd/unexpected that would undermine CLARITY-AD as a clearly positive trial, while on the safety side there were no surprises."
Raymond James analysts: "While there were no obvious issues in the dataset, our first impression is that the detailed results have had little impact on the fields' preconceived notions of the asset. That being said, we do think the data are supportive of a full approval, and we believe CMS will have to offer reimbursement for the drug. The main outstanding questions in our view are: which AD populations are the ideal candidates for lecanemab and how broad will adoption be?"
Oppenheimer analysts: "We anticipate an eventual CMS coverage update likely in 2024 to be the ultimate catalyst for BIIB. We believe CLARITY-AD results support clinical benefit that should address the CED. We view BIIB as well-positioned with a new CEO following 3Q22 results, and look forward to partner Eisai's filing for full approval by 1Q23-end."
Morgan Stanley analysts: "Overall, we view the results as robust and see today's data presentation as reducing fear that detailed data would not stand up to scrutiny. Investors were focused on subgroup effects and safety… we believe the data can help focus physicians on key patients to treat which we view as a positive commercially. We expect BIIB higher on the clear data."
Goldman Sachs analysts: "We next look to regulatory approvals (January 6 PDUFA for accelerated approval; full approval filings in the US, EU and Japan in 1Q23) and, importantly, expect the demonstrated functional benefit will meet CMS' high level of evidence requirement to support broad coverage. We model for lecanemab peak global sales of $14bn, of which we estimate ~$7bn are priced in at ~$290/share."
As of 08:55 EST (13:55 GMT) Biogen shares are up over 4% in pre-open Wednesday.