Biogen fizzles despite catalysts after powering Alzheimer’s stocks into 2022
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Defying the underperformance of the biotech space in 2021, many clinical-stage firms developing therapies for Alzheimerâs disease rallied. However, Biogen (NASDAQ:BIIB), a major reason for their outperformance with the FDA approval for its Alzheimerâs therapy, Aduhelm, lagged, notwithstanding its key milestones ahead, as shown in this graph.

Given the unmet medical need, the companies focused on Alzheimerâs will continue to enjoy outsize gains even as the challenging nature of therapeutic development brings volatility. The number of patients suffering from the memory-robbing disease is expected to more than double by 2050 globally from an estimated ~30 million currently.
In June (BIIB) and Eisai (OTCPK:ESALY) won the U.S. regulatory clearance for Aduhelm making it the first FDA-approved therapy for the memory-robbing disease in nearly two decades. However, the modern-day trailblazers against Alzheimerâs have lagged in 2021, with declines of ~2.0% and ~20.6%, respectively, contrasting the ~24.2% gain in the Health Care Select Sector SPDR (NYSEARCA:XLV).
Despite its weakness post controversial approval of Aduhelm and the unsustainable pricing strategy employed by the company, Biogen (BIIB) looks set to drive another Alzheimer's rally next year given its upcoming catalysts as Wall Street continues to bet on the stock.

The Centers for Medicare and Medicaid Services (CMS) is set to complete its national coverage determination (NCD) process for Aduhelm in January, and a positive outcome could improve the slow early uptake of the drug and address the payersâ concerns. Biogen (BIIB) and Eisai (OTCPK:ESALY) have another Alzheimerâs target on their pipeline. Currently undergoing a Phase 3 clinical trial involving more than 1,700 patients, lecanemab is set to generate late-stage data in the fall of 2022.
Meanwhile, donanemab, a late-stage candidate from Eli Lillyâs (NYSE:LLY), is another highly anticipated catalyst in the subsector. The monoclonal antibody is undergoing several Phase 3 trials, and after its initial Phase 2 data early this year, the investors added $18B to the companyâs valuation in a single day, helping the stock to end 2021 ~63.6% higher. Having already started the rolling submission for its FDA clearance, Indiana-based pharma giant expects the regulators to grant the accelerated approval for donanemab before its phase 3 data are available in 2023.
Meanwhile, Lillyâs European rival Roche (OTCQX:RHHBY) is not far behind with its Alzheimerâs candidate gantenerumab, for which Phase 3 data are expected in H2 2022. The Swiss pharma giant has already pledged to undercut Biogen (BIIB) in Alzheimerâs with plans to price its amyloid-targeting monoclonal antibody 30% less than the cost of Aduhelm.

The performance of several clinical stage biotechs will also be in focus after their valuations soared multiple times in 2021, thanks in part to Aduhelm approval. Contrasting the ~20.5% decline in the SPDR S&P Biotech ETF (NYSEARCA:XBI), Cassava Sciences (NASDAQ:SAVA) has climbed ~540.8% even as the company continued to battle the allegations over data manipulation related to its experimental therapy simufilam.

Those who doubt how long Cassava (SAVA) could sustain the momentum are likely to focus on how well the company can navigate its clinical and non-clinical challenges in 2022 as it advances simufilam in two Phase 3 clinical trials.
After more than doubling in value, Annovis Bio (NYSE:ANVS) will also be on investorsâ radar as the company plans to seek FDA guidance in Q1 2022 to start late-stage trials for its Alzheimerâs candidate ANVS401. Berwyn, Pennsylvania-based biotech jumped in May after investors cheered the Phase 2 data for ANVS401, only to pare gains after presenting new data for the candidate at a major medical conference on Alzheimerâs in July.

Among decliners, Athira Pharma (NASDAQ:ATHA) is set to generate a major catalyst when it releases the initial Phase 2 data for its Alzheimerâs candidate ATH-1017 in H2 2022. Despite a ~62.0% YTD decline, a majority of Wall Street analysts continue to have Bullish views on the stock.