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Biogen (BIIB) shares jumped 5% on Monday after the U.S. Food and Drug Administration approved the first at-home starting dose for its Alzheimer’s treatment, Leqembi.
The decision marks a major shift in how patients can begin therapy for early Alzheimer’s disease.
Patients with mild cognitive impairment or mild dementia due to Alzheimer’s can now begin treatment with a subcutaneous (under-the-skin) injection given once every week.
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They or a caregiver can administer it at home using an autoinjector. Previously, the starting phase required intravenous infusions at a clinic or infusion center for the first 18 months.
This approval completes a fully at-home pathway when combined with the earlier approval of weekly at-home maintenance dosing after the initial treatment period. Leqembi, developed by Eisai and co-commercialized by Biogen, is the only approved anti-amyloid therapy with both starting and maintenance options that can be given outside a medical facility.
The change is expected to reduce the burden on patients and families who previously had to travel regularly for clinic visits.
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The FDA based the approval on data showing the subcutaneous starting dose produces similar drug exposure and plaque-clearing effects as the intravenous version.
Wall Street reacted positively, with several firms raising targets after the approval came about six weeks ahead of the Aug. 24 target date.
Wedbush lifted its price target to $201 from $196, keeping a ‘Neutral’ rating while updating its model ahead of Biogen’s second-quarter earnings due July 29.
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Truist upgraded the stock to ‘Buy’ from ‘Hold’ and raised its target to $235 from $190. The firm cited expectations for differentiated mid-stage data on Biogen’s diranersen in Alzheimer's disease, slated to be announced mid-July at a London conference, plus upcoming late-stage clinical readouts, as reasons for a more constructive outlook.
RBC Capital reiterated its ‘Outperform’ rating and $242 price target. Analysts said the early approval should help Biogen and Eisai regain market share against competitor Kisunla and could reignite commercial enthusiasm for Alzheimer’s therapies if Leqembi delivers a strong Q2 sales performance. The fresh price targets imply an upside of 1%-22% from the stock’s last closing price.
On Stocktwits, retail sentiment around BIIB stock stayed within the 'bullish' territory over the past 24 hours, while message volume remained at ‘normal' levels.
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According to data from Koyfin, 21 of the 36 analysts covering BIIB stock rate it ‘Buy’ or higher, while 14 rate it ‘Hold’ and one rates it ‘Sell.’ The stock has a 12-month average price target of $222.83, representing a potential upside of about 12% from the stock’s last close.
BIIB stock has gained 18% year-to-date.
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