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Eisai Co., Ltd. and Biogen Inc. recently announced that Australia’s Therapeutic Goods Administration approved LEQEMBI (lecanemab) for use in adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, supported by positive Phase 3 Clarity AD trial data.
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This marks another key regulatory milestone that expands LEQEMBI’s international reach, as new dosing options gain approval in countries including China and the US, potentially making Alzheimer’s treatment more accessible.
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We’ll examine how these expanded approvals for more convenient dosing may strengthen Biogen’s global growth trajectory and pipeline confidence.
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For anyone considering Biogen, confidence in the company’s future remains closely tied to the commercial momentum of new therapies like LEQEMBI, with global Alzheimer’s approvals viewed as the critical near-term catalyst. The recent Australian approval for LEQEMBI, supported by rigorous clinical data, should enhance patient access and geographic reach, yet the largest immediate risk remains the commercial uptake and continued competitive pressure across Alzheimer’s and other key franchises.
The European Commission’s recent approval of ZURZUVAE for postpartum depression adds another growth avenue, highlighting Biogen’s efforts to broaden its late-stage neurology pipeline and mitigate reliance on a small group of therapies. However, the real test for shareholders continues to hinge on how quickly and broadly LEQEMBI, and other novel launches, gain traction versus entrenched rivals and reimbursement hurdles.
On the other hand, investors should also be alert to the intensifying MS competition and the looming threat of escalating price and reimbursement pressure in key markets…
Read the full narrative on Biogen (it’s free!)
Biogen’s outlook anticipates $9.4 billion in revenue and $2.1 billion in earnings by 2028. This implies a 2.1% annual revenue decline and a $0.6 billion earnings increase from the current $1.5 billion.
Uncover how Biogen’s forecasts yield a $170.03 fair value, a 10% upside to its current price.
Seven individual fair value estimates from the Simply Wall St Community span a wide US$100 to US$367.65 per share range, revealing sharp differences. In light of these varied views, expanding Alzheimer’s therapy approvals offer fresh potential, but shifts in market adoption and policy could reshape outcomes, be sure to explore the different community perspectives.