Some patients who received Biogen's Alzheimer's drug for more than two years showed slower cognitive decline, the biotech company said Wednesday — leading Biogen stock to tick higher.
After two and a half years, Aduhelm-treated patients showed lower levels of two biomarkers tied to the neurodegenerative disease. Further, some showed a slower cognitive decline.
The results help make Biogen's case for Aduhelm's approval. The U.S. Food and Drug Administration granted Aduhelm an accelerated approval last year based on its ability to clear a plaque in the brain associated with Alzheimer's disease. So Biogen now must show that mechanism benefits cognition.
On the stock market today, Biogen stock rose 3.3% to 203.80.
Biogen Stock: 'Significant' Declines
Patients in the study showed "significant" declines in amyloid beta and p-tau181. Aduhelm gained approval for its ability to clear amyloid beta. P-tau181 is a newer biomarker researchers associate with a heightened risk for Alzheimer's disease.
Now, data from two final-phase studies show Aduhelm slowed cognitive decline for patients who had reduced p-tau181 after a year and a half of treatment. Also, those patients had declined less on four measures of cognition and function.
The results demonstrate the potential benefit of long-term Aduhelm treatment, Samantha Budd Haeberlein, Biogen's head of neurodegeneration development, said in a written statement. But Biogen stock has trended down for nine months as the scientific community debates Aduhelm's merits.
"These are meaningful findings, which further our understanding of amyloid and downstream biomarkers, such as p-tau181, in Alzheimer's disease and can help inform how long patients may benefit from treatment to reduce amyloid beta plaque," she said.
CMS Decision Due Next Month
The news helped Biogen stock gap higher, though shares remain below their key moving averages, according to MarketSmith.com.
Next month, the Centers for Medicare and Medicaid Services will decide whether it will cover the cost of Aduhelm treatment for patients in its system. Currently, CMS only reimburses Aduhelm costs for patients enrolled in clinical studies.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.