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CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a prominent biotechnology company currently trading near its 52-week low and considered undervalued by InvestingPro analysts, announced today that the U.S. Food and Drug Administration (FDA) has awarded Fast Track designation to its investigational drug, BIIB080, for the treatment of Alzheimer’s disease. This designation is intended to hasten the development and review process for treatments of serious conditions that fulfill unmet medical needs.
BIIB080 is an antisense oligonucleotide (ASO) therapy targeting tau, a protein associated with neurodegeneration in Alzheimer’s disease. It is the first tau-targeting ASO to enter clinical development for this condition. The drug is currently being examined in the global Phase 2 CELIA study, which includes individuals with early-stage Alzheimer’s disease. With a robust gross profit margin of 76% and a strong financial health score rated as "GREAT" by InvestingPro, Biogen appears well-positioned to support its research initiatives.
The Fast Track status was granted following results from a Phase 1b study, which indicated dose-dependent reductions in soluble tau protein in cerebrospinal fluid and decreases in aggregated tau pathology in the brain, measured by positron emission tomography. Additionally, there were favorable trends in exploratory clinical outcomes, suggesting potential clinical benefits.
Priya Singhal, M.D., M.P.H., Head of Development at Biogen, expressed optimism about the FDA’s recognition of the urgent need for innovative treatments targeting tau pathology. Singhal emphasized the complexity of Alzheimer’s disease and the necessity for multiple therapeutic approaches to tackle its diverse pathologies.
The Phase 2 CELIA study is fully enrolled, with results expected in 2026. Biogen, which was founded in 1978, is known for pioneering innovative science to deliver new medicines and create value for shareholders and communities. With a market capitalization of $19.3 billion and attractive P/E ratio of 11.8, the company maintains a strong market position. Investors can access comprehensive analysis and additional insights through InvestingPro’s detailed research reports, which cover over 1,400 US stocks including Biogen. The company routinely posts information that may be important to investors on its website.
The news release also contains forward-looking statements regarding the potential effects and benefits of BIIB080, as well as its safety, efficacy, and the timing of regulatory discussions and approvals. Biogen warns that drug development and commercialization involve high degrees of risk, and early-stage clinical trial results may not be indicative of full results from later-stage trials.
This development marks a significant step in Biogen’s efforts to address Alzheimer’s disease, with the Fast Track designation potentially leading to a more expedited review by the FDA. This information is based on a press release statement from Biogen.
In other recent news, Organon has acquired the U.S. regulatory and commercial rights for TOFIDENCE™, a biosimilar to ACTEMRA®, from Biogen. This acquisition involves an upfront payment to Biogen, with Organon responsible for tiered royalty payments and milestone payments to Bio-Thera Solutions Ltd., the developer of TOFIDENCE™. Meanwhile, Biogen has announced plans to establish its new global headquarters in Cambridge, Massachusetts, expected to open by 2028. This new facility will centralize Biogen’s operations and is part of a long-term plan to optimize its real estate footprint.
Biogen has also entered into a strategic collaboration with Stoke Therapeutics to develop and commercialize zorevunersen, a potential treatment for Dravet syndrome, outside of North America. The Phase 3 EMPEROR study for zorevunersen is anticipated to begin in 2025, with results expected in 2027. Oppenheimer has maintained its Outperform rating for Biogen, citing the collaboration with Stoke as a positive addition to Biogen’s portfolio. In contrast, Piper Sandler has adjusted its price target for Biogen to $135, maintaining a Neutral rating due to concerns over revenue forecasts and competitive pressures. These developments reflect Biogen’s ongoing efforts to expand its pipeline and strengthen its market position in neurological therapies.
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