In pre-hour trades, Biogen Inc. (BIIB) shares gained 45.61% to $288.00 after a surprise trial success. BIIB stock closed at $197.79, up just 1.04%.
What trial did BIIB see success in?
In partnership with Eisai, Biogen (BIIB) yesterday announced positive results for lecanemab, an experimental Alzheimer drug, in a large global Phase 3 confirmatory clinical trial.
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- This anti-amyloid beta protofibril antibody is being tested for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively called early AD) when there is confirmed amyloid pathology in the brain.
- As a result of highly statistically significant results on the primary endpoint and all secondary endpoints, Eisai will discuss this data with regulatory authorities in Japan, the United States, and Europe.
- By the end of Eisai’s FY2022, which runs from March 31, 2023, Eisai intends to apply for traditional approval in the US and for marketing authorization in Japan and Europe.
- A peer-reviewed journal will publish the findings of the Clarity AD study on November 29, 2022, at the Clinical Trials on Alzheimer’s Congress (CTAD).
- According to the trial results released late Tuesday, years of clinical failures may have resulted in a rare victory in finding a treatment for Alzheimer’s disease.
- In a large trial of patients with Alzheimer’s, Biogen and Eisai found that lecanemab slowed brain-wasting disease by 27% compared to a placebo.
- Due to the fact that the results do not seem to be ambiguous, they are pretty much the best-case scenario for the program.
- Amyloid beta, a toxic protein plaque considered crucial to arresting the progress of brain disease, is targeted by the drug, but previous attempts have failed repeatedly.
- It was the so-called amyloid hypothesis that suffered a significant blow last year when U.S. regulators overruled a panel of outside experts and approved a Biogen drug called Aduhelm on the grounds that it cleared plaques rather than slowed cognitive decline.
How are analysts describing BIIB’s success?
Biogen (BIIB) and Eisai’s lecanemab’s latest trial success raises hopes for Roche’s gantenerumab and Lilly’s donanemab trials. The healthcare analyst at Citeline, Daniel Chancellor, said it’s important to reward and incentivize results like these since there haven’t been many wins to celebrate or anything close to a return on investment. BMO analyst Evan Seigerman hailed the data as an “unequivocal win” for Alzheimer’s patients as well as BIIB.