Needham analysts see Biogen's Lecanemab Data Not 'Slam Dunk' For Complete CMS Approval

 

• Biogen Inc BIIB and its partner Eisai Limited ESALY announced a significant surprise, with lecanemab's confirmatory Phase 3 Clarity study meeting the primary endpoint in early Alzheimer's Disease (AD).
• The data showed a statistically significant reduction of clinical decline in cognitive and functional scale compared to placebo in close to 1,800 participants.
• RBC Capital Markets writes that much of Biogen's future direction depended on the outcome of lecanemab data.
• The RBC analyst believes the data should support a high likelihood of full approval, CMS reimbursement, and $8 billion in out-year global sales and should transform Biogen into an earnings growth story starting in 2024. 
• It reiterates its Outperform rating with an increased price target of $321 from $251.
• Needham believes that the key question on full CMS coverage for lecanemab still hangs, and traditional FDA approval does not automatically grant. 
• "We don't believe the CLARITY AD results are a slam dunk to convince CMS to do so," Needham writes.
• Needham says it's still too early to say that lecanemab will be a multi-billion dollar opportunity, but this likelihood is certainly higher now.
• SVB notes the positive results will reinvigorate the AD space and increase the focus of the investor community for the two near-term readouts from Roche Holdings AG RHHBY and Eli Lilly And Co LLY and any potential differentiating features that emerge. 
• SVB says that with the data overhang cleared, new CEO at Biogen is expected in the next few months and looks forward to additional detailed data at CTAD on November 29. SVB maintains the Outperform rating.

https://www.benzinga.com/analyst-ratings/analyst-color/22/09/29056677/this-analyst-believes-biogens-lecanemab-data-not-slam-dunk-for-complete-cms-approva