Shares of Biogen surged as much as 43% on Wednesday after the company said a Phase 3 clinical trial of its experimental Alzheimer’s drug lecanemab was successful in meeting primary and secondary endpoints.
Specifically, the drug helped reduce the rate of cognitive decline in people with early Alzheimer’s disease by 27% over 18 months compared to a placebo. This is a statistically significant result that represents a breakthrough in biotechnology’s ongoing quest to end the progression of Alzheimer’s disease.
“Today’s announcement gives patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease and provide a clinically meaningful impact on cognition and function,” said Biogen CEO Michael Vounatsos.
Lecanemab is an anti-amyloid drug that helps remove plaque from the brain, which is thought to play a role in the progression of Alzheimer’s disease. The drug is separate from Biogen’s Alzheimer’s drug aduhelm, which was approved by the FDA last year in what was seen as a controversial decision.
Aduhelm has so far received little interest from the medical community due to conflicting trial results, high cost and little to no reimbursement for the drug. But the woes facing aduhelm early to market may not apply to lecanemab after such definitive phase III results.
“We see today’s data supporting full approval for lecanemab … And assuming full approval, we would expect CMS reimbursement and a meaningful commercial opportunity for lecanemab (as opposed to the challenges Aduhelm faces on the reimbursement front),” JPMorgan analyst Chris Schott said. Schott’s preliminary estimates suggest that lecanemab could generate between $6 billion and $10 billion in peak sales.
Positive results from Biogen’s Alzheimer’s drugs are driving a handful of stocks that are focused on developing therapies in the space. Biogen developed lecanemab in partnership with Japanese biotech company Eisai, whose shares rose nearly 20% on Wednesday.
The drug lecanemab was originally licensed from Sweden’s BioArctic, whose shares rose 168% in trading on Wednesday.
Meanwhile, shares of Roche and Eli Lilly, both working on their own Alzheimer’s drugs, rose 5% and 8% on Wednesday.
Biogen is seeking fast-track FDA approval for the drug in early 2023, with Jan. 6 set as the date for passage of the Prescription Drug User Fee Act.