Milestone drug approvals failed to boost Biogen’s growth.
BIIB
Shares rose early Friday as analysts analyzed Thursday’s actions by the U.S. Food and Drug Administration on the Alzheimer’s drug Rekumbi.
Rekenbi, co-developed by Biogen and Eisai Co., Ltd., has been approved following the much-anticipated full FDA approval.
Esaruf
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Some analysts have highlighted potential problems in the drug’s rollout. “There are many bottlenecks, especially infusion center capacity, which are likely to slow down the rollout,” Raymond James analysts said in a research note on Thursday. Lekembi he is given intravenously every two weeks and the infusion is usually done in a hospital or infusion therapy center.
Analysts at Raymond James, which tracks the market performance of Biogen shares, said Biogen has suggested Rekumbi won’t be profitable until the second half of next year or 2025. Eisai’s subcutaneous form of Rekembi, currently under development, “will be critical to tapping the Alzheimer’s market, especially given the need for biweekly infusions and the current constraints on infusion capacity,” the analysts wrote.
In a note on Thursday, Wedbush analysts reiterated their neutral assessment of the Biogen stock, saying logistics “could weigh on adoption” of Rekumbi.
But some analysts expect billions of dollars in revenue from Rekumbi in the next few years. With about 1.5 million early-stage Alzheimer’s patients in the U.S. and an annual price tag of about $26,500, 13% market penetration would drive about $5.2 billion in U.S. sales, TD Cowen analysts say. said in a note on Thursday. Analysts rate Biogen as an outperformer with a price target of $315. Analysts at William Blair said in a note on Friday, “Assuming the subcutaneous delivery option is approved to alleviate infusion center bottlenecks, Rekumbi’s global sales could exceed $8 billion in 2030. We anticipate that otherwise we will have limited availability,” the analysts reiterated their outperformance rating in a note on Friday. Biogen stock.
The FDA’s decision on the drug’s labeling came under scrutiny from analysts after full approval. According to the FDA, the label will include a boxed warning about the risk of amyloid-related imaging abnormalities, which often manifest as temporary brain swelling but are rarely serious and life-threatening. said to be potentially threatening. Rekenbi’s full approval “ultimately is mixed,” Stifel analysts said in a report Thursday. Analysts rate Biogen stock as a buy.
The FDA said people with two copies of a gene called APOE4 are at increased risk of amyloid-related imaging abnormalities, so patients should be tested for a gene called APOE4 before starting treatment with Rekembi. . Although there is currently no FDA-approved test for the APOE4 gene, “when considering Lekembi, commercially available genotyping should already be part of the patient work-up and presents a barrier to treatment.” We don’t think it should,” analysts at William Blair wrote in the paper. Note Friday. Analysts rate it as outperforming the Biogen stock.
The revised label includes stricter warnings, but “does not limit its use in major groups,” TD Cowen analysts wrote in a note Thursday. “We believe this change is unlikely to affect Rekumbi’s potential.”
As expected, the Centers for Medicare and Medicaid Services announced that broader Medicare coverage for Rekumbi is now available following the FDA’s approval decision. As a condition of coverage, Medicare requires that beneficiary doctors and clinical teams participate in gathering real-world evidence of how drugs work (a system known as a registry). The requirements should not be unduly burdensome for prescribers and analysts. Said. Analysts at William Blair write that the registry appears easy to use and documents the data that providers typically collect when determining a patient’s eligibility for Rekembi.
Leqembi’s road to full approval also affects Eli Lilly
Lily
Analysts say the drug under investigation for Alzheimer’s disease is donamab. Rekumbi’s risks and benefits were discussed at an FDA advisory committee in June, but “we continue to doubt that the safety data for donanemab will come under more scrutiny,” he said, referring to the Alzheimer’s disease conference later this month. Details of a clinical trial of donanemab are scheduled at an international conference of disease associations. Oppenheimer analysts said in a report on Friday. Analysts have rated Biogen stock as an outperformer with a price target of $360.
Biogen shares fell more than 1% on Friday morning, while Eisai’s U.S.-listed shares fell nearly 3% and Eli Lilly shares fell 1.4%.
