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Biogen's (BIIB) Partner Eisai Files MAA for Lecanemab in Europe
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Biogen Inc. (BIIB - Free Report) and partner Eisai announced that the latter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for their anti-amyloid beta protofibril antibody candidate, lecanemab to treat early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease [AD] and mild AD dementia).
The filing in Europe was based on data from the phase III Clarity AD study and the phase IIb clinical study (Study 201), which evaluated lecanemab for the given indication. Data from the same showed that treatment with lecanemab demonstrated a reduction of clinical decline in early AD and is subject to validation to determine whether the EMA accepts the application for review.
The Clarity AD study met its primary endpoint and all key secondary endpoints by demonstrating highly statistically significant results.
Shares of Biogen have rallied 24.9% in the past year against the industry’s decline of 17.6%.
Image Source: Zacks Investment Research
Last week, the FDA granted accelerated approval to lecanemab under the brand name Leqembi to treat early Alzheimer’s disease (early AD).
Eisai has priced Leqembi at a wholesale acquisition cost of $26,500 per year.
Eisai also filed a supplemental biologics license application (sBLA) to the FDA to get a traditional approval for Leqembi. Eisai plans to file an MAA for lecanemab in Japan by March 2023.
Biogen has developed lecanemab in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Eisai and Biogen will co-commercialize and co-promote the drug. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but has failed to generate meaningful sales.
Aduhelm’s FDA approval in June 2021 faced a lot of criticism about its mixed efficacy results, the FDA selection of the accelerated approval path and the regulatory process in general. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in a slow launch.
Some other large-cap pharma companies like Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) are also developing beta amyloid-targeting drugs for AD indication. The Alzheimer’s candidates of these companies are in late-stage development or review and are expected to be launched in the upcoming months.
Eli Lilly’s BLA seeking accelerated approval of donanemab, based on data from the TRAILBLAZER-ALZ study, is already under review with the FDA. A decision is expected in early 2023. Lilly also expects a data readout from the phase III TRAILBLAZER-ALZ 2 study by mid-2023, which, if positive, will form the basis of its application for traditional regulatory approval for donanemab.
Roche’s phase III GRADUATE I and II studies on a key Alzheimer’s pipeline candidate, gantenerumab, failed to meet the primary endpoint of slowing clinical decline in people with early Alzheimer’s disease in November 2022. The level of beta-amyloid removal by gantenerumab was less than expected. Roche was developing the candidate in collaboration with MorphoSys.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 6.5% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.
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Biogen's (BIIB) Partner Eisai Files MAA for Lecanemab in Europe
Biogen Inc. (BIIB - Free Report) and partner Eisai announced that the latter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval for their anti-amyloid beta protofibril antibody candidate, lecanemab to treat early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease [AD] and mild AD dementia).
The filing in Europe was based on data from the phase III Clarity AD study and the phase IIb clinical study (Study 201), which evaluated lecanemab for the given indication. Data from the same showed that treatment with lecanemab demonstrated a reduction of clinical decline in early AD and is subject to validation to determine whether the EMA accepts the application for review.
The Clarity AD study met its primary endpoint and all key secondary endpoints by demonstrating highly statistically significant results.
Shares of Biogen have rallied 24.9% in the past year against the industry’s decline of 17.6%.
Image Source: Zacks Investment Research
Last week, the FDA granted accelerated approval to lecanemab under the brand name Leqembi to treat early Alzheimer’s disease (early AD).
Eisai has priced Leqembi at a wholesale acquisition cost of $26,500 per year.
Eisai also filed a supplemental biologics license application (sBLA) to the FDA to get a traditional approval for Leqembi. Eisai plans to file an MAA for lecanemab in Japan by March 2023.
Biogen has developed lecanemab in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Eisai and Biogen will co-commercialize and co-promote the drug. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but has failed to generate meaningful sales.
Aduhelm’s FDA approval in June 2021 faced a lot of criticism about its mixed efficacy results, the FDA selection of the accelerated approval path and the regulatory process in general. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in a slow launch.
Some other large-cap pharma companies like Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) are also developing beta amyloid-targeting drugs for AD indication. The Alzheimer’s candidates of these companies are in late-stage development or review and are expected to be launched in the upcoming months.
Eli Lilly’s BLA seeking accelerated approval of donanemab, based on data from the TRAILBLAZER-ALZ study, is already under review with the FDA. A decision is expected in early 2023. Lilly also expects a data readout from the phase III TRAILBLAZER-ALZ 2 study by mid-2023, which, if positive, will form the basis of its application for traditional regulatory approval for donanemab.
Roche’s phase III GRADUATE I and II studies on a key Alzheimer’s pipeline candidate, gantenerumab, failed to meet the primary endpoint of slowing clinical decline in people with early Alzheimer’s disease in November 2022. The level of beta-amyloid removal by gantenerumab was less than expected. Roche was developing the candidate in collaboration with MorphoSys.
Zacks Rank & Stock to Consider
Biogen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Syndax Pharmaceuticals, Inc. (SNDX - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 6.5% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average.