Biogen stock jumped early Wednesday after the Food and Drug Administration gave its Eisai-partnered Alzheimer's treatment a fast-track designation.
The companies are submitting information on a rolling basis for approval of an under-the-skin injection of their Alzheimer's drug Leqembi. Today, Leqembi is a twice-monthly infusion. But experts say a weekly shot could open up the market, making it easier to treat patients who can't easily travel to infusion centers.
"While they are effective, infusions are a time-consuming burden on patients and add an additional strain on our stretched health care system, where we are already experiencing a shortage of doctors treating dementia patients," UsAgainstAlzheimer's chair and co-founder, George Vradenburg, said in a statement.
On the stock market today, Biogen stock popped 3.7%, closing at 235.32. Shares hit a recent low in mid-April, but have since climbed more than 24%, as of Wednesday's close.
An 'Incremental Positive' For Biogen Stock
Last month, the FDA delayed Biogen and Eisai's subcutaneous Leqembi by asking for three more months of test results. Eisai says the companies are now submitting data from an open-label extension study and modeling of observed data. In an open-label extension study, all patients are knowingly receiving the test drug.
If approved, the under-the-skin shot of Leqembi would be delivered in an auto-injector. Under the new regimen, patients would receive the biweekly intravenous infusion of Leqembi to clear away the toxic plaque in the brain. Then, they would switch to the subcutaneous shot to continually fend off accumulating plaque.
William Blair analyst Myles Minter kept his outperform rating on Biogen stock. He called the news an "incremental positive" for the company.
Leqembi Faces Challenges But Gaining Patients
He notes the Leqembi launch in the U.S. faces infrastructure challenges, but is showing signs of an increased trajectory. There are about 5,000 patients receiving Leqembi for early Alzheimer's treatment. In the fourth quarter, only 2,000 patients were on Leqembi.
"More than 20% of total patients on therapy were added in March 2024 with unique prescribers doubling in the same period, and we believe that patients able to tolerate therapy could find the subcutaneous maintenance option favorable from a compliance perspective," William Blair's Minter said in a report.
Despite the recent move, Biogen stock has a low IBD Digital Relative Strength Rating of 19, meaning shares rank in the lowest fifth of all stocks when it comes to 12-month performance.
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