Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
With the U.S. launches of anti-amyloid therapies Leqembi and Kisunla now firmly in the rearview mirror, the Alzheimer’s space—including Biogen—is moving to the next chapter.
On Tuesday at the J.P. Morgan Healthcare Conference, the Massachusetts-based company served analysts a breakfast and a presentation, from which BMO Capital Markets walked away “appreciative of the company’s potential avenues for expansion in Alzheimer’s,” according to a Tuesday afternoon note to investors.
Leqembi was “top of mind” for many at the breakfast who were “looking to understand how the key growth product could continue to expand in 2026,” BMO wrote. Management acknowledged that Biogen’s product now shares the market about equally with Eli Lilly’s Kisunla—which was approved in July 2024, a year and a half after Leqembi—but noted that patient adherence was “surprisingly high,” according to BMO.
Beyond the original product, BMO said that approval of a subcutaneous induction dose of Leqembi could provide another lever of growth. In September last year, the FDA greenlit a subcutaneous formulation, Leqembi Iqlick, for maintenance dosing—that is, for patients who have been treated with the drug for 18 months.
“Induction subQ dosing could be one of the more underappreciated opportunities for Leqembi, with potential approval positioning the product with a clear advantage over Kisunla which remains only available via IV,” the analysts wrote. Biogen has submitted for approval of the subQ induction formulation.
In Biogen’s J.P. Morgan presentation on Monday, CEO Christopher Viehbacher discussed this pending approval.
“That’s going to be also extremely important, partly because we do have a competitor and the competitor offers once monthly infusion versus our every 2-week infusion,” Viehbacher said of the product, presumably referring to Lilly’s Kisunla. “But that advantage is going to go away once we have a subcutaneous formulation,” he added, explaining that the maintenance dose requires one autoinjector per week, but the induction dose will be given simultaneously via two autoinjectors. “So that will improve not only the patient experience, but it simplifies the pathway.”
Biogen’s other major upcoming Leqembi catalyst is the AHEAD 3-45 study in patients with preclinical, or presymptomatic, Alzheimer’s disease. The study is not expected to be complete until the end of 2028, according to ClinicalTrials.gov, while Lilly’s TRAILBLAZER-ALZ 3 study in the same patient population is projected to read out in November 2027.
At the breakfast, Biogen management said that while the results from Lilly’s TRAILBLAZER-ALZ 3 “could be compelling and helpful for the field,” they are unlikely to influence whether the company takes an interim readout for AHEAD 3-45 trial, according to BMO.
“I do think, by the end of this decade, that we’re probably going to be looking at earlier-stage patients because you’re getting so much more benefit from that,” Viehbacher said when asked about these studies during the Q&A period of Biogen’s presentation. “But it’s a huge opportunity.”
And it’s an opportunity that hard work with the initial launch of the anti-amyloid antibody class should help ease, Jane Grogan, Biogen’s head of research, told BioSpace on the sidelines of JPM. When Biogen, along with partner Eisai, launched Leqembi, they faced challenges as physicians had to change the way they practiced. Providers were unprepared for the MRI tests that were required before and during treatment.
“The difficulty and the beauty about being first into a disease area is that you have to crack it open,” Grogan said.
That infrastructure and those relationships have now been built, and new tests have emerged to easily diagnose and ensure the right patients are getting forwarded to specialists for potential treatment. So once the presymptomatic data are in hand, Grogan is confident the team can launch with fewer issues than last time.
“We know how to find patients. We know how to find the doctors that are prescribing,” she said. “We’ve set the groundwork to really be able to enable really robust launches in the future Alzheimer’s indications.”
Of course, the data need to be positive. Grogan said Biogen has set up “the most comprehensive clinical trial to answer the hypothesis.” The length of the trial and the planned 2028 readout is meant to ensure the company rigorously tests whether Leqembi can disrupt the disease before symptoms present.
The Next Chapter
Biogen is also an active player on the next-gen Alzheimer’s front. The company is going after the second most common Alzheimer’s target, tau, with BIIB080, an antisense oligonucleotide (ASO) licensed from long-time partner Ionis Pharmaceuticals. BIIB080 is currently being tested in the Phase II CELIA trial, for which a readout is expected in mid-2026.
Tau has tripped up many a biopharma company in recent years. Johnson & Johnson was the latest company to strike out when its candidate posdinemab failed to slow clinical decline in a mid-stage trial in November 2025. Other members of this particular R&D wasteland include UCB and Eli Lilly.
“Our belief is that with an ASO, we can act on intracellular tau,” Viehbacher said during his presentation on Monday.
Biogen “sounded a bit more cautious” regarding the upcoming readout, RBC Capital Markets analysts said in a Tuesday note to investors recapping the breakfast. “They believe ASO construct should provide key advantages over anti-Tau antibodies in development, though acknowledged high risk and want to see impact on both PET Tau and clinical measures in mid-year data.”
However, the analysts added, “We do not believe there are significant expectations for this asset given the intrathecal delivery.”
Another emerging technology Biogen is exploring is a brain shuttle, intended as a way to better move drugs across the blood-brain barrier. Rival Roche recently revealed early results for trontinemab showing plaque clearance in nine out of 10 patients. And Novartis recently signed a deal with BioArctic to work on brain penetrating therapies for Alzheimer’s.
Biogen has teamed up with C4 Therapeutics on brain penetration technology, and another partnership with Neomorph to work on molecular glues could be complementary. Grogan is also excited about the potential of siRNA in Alzheimer’s.
“This whole field is waking up and emerging, and it’s very exciting. I think all boats will rise together here,” Grogan told BioSpace. “It’s a terrifically exciting time for neurology, and there’s a lot to work out, but there will be a lot of movement in this field.”
