Biogen (BIIB), Denali Begin Mid-Stage Study on Parkinson's Drug
Biogen Inc. BIIB and its collaboration partner Denali Therapeutics Inc. DNLI announced that they have initiated dosing in a phase IIb study — LUMA — evaluating their pipeline candidate, BIIB122 (DNL151).
The LUMA study will compare the efficacy and safety of BIIB122 with a placebo in patients with early-stage Parkinson’s disease aged between 30 and 80 years. The primary endpoint of this mid-stage study is Time to Confirmed Worsening in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) parts II and III combined score over the treatment period. Per the International Parkinson and Movement Disorder Society, the scale measures various aspects of Parkinson’s disease, including non-motor and motor experiences of daily living and motor complications, and characterizes the extent and burden of the disease.
Biogen and Denali’s BIIB122 targets a novel gene, LRRK2, that has the potential to impact the underlying biology and slow the progression of Parkinson’s disease. The companies are developing an oral formulation of this LRRK2-inhibiting therapy for Parkinson’s disease.
Biogen and Denali entered into a collaboration in 2020 to design a rigorous development program to evaluate BIIB122 in patients with and without LRRK2 mutations. As part of their collaboration, Biogen and Denali are planning to start a phase III study — LIGHTHOUSE — to evaluate BIIB122 in individuals with Parkinson’s disease with LRRK2 pathogenic variants later this year.
Biogen’s stock has declined 16.6% this year so far compared with a decrease of 22.1% for the industry.
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Biogen is one of the world’s leading biotechnology companies, focusing on developing innovative therapies for treating serious neurological and neurodegenerative diseases, including its core growth areas of multiple sclerosis (MS) and neuroimmunology, Alzheimer’s disease (AD) and dementia, movement disorders including Parkinson's disease, neuromuscular disorders, including spinal muscular atrophy (SMA) and amyotrophic lateral sclerosis and ophthalmology.
Key multiple sclerosis/MS drugs in its portfolio are Tecfidera, Vumerity, Avonex, Plegridy and Tysabri. With competition in the MS market intensifying, Biogen has diversified its pipeline across neuroscience and the adjacent therapeutic areas. Biogen, at present, has over 30 clinical programs in a broad set of disease areas and modalities, 10 of which are in late-stage development or under review. Apart from MS drugs, other approved/marketed products include Fumaderm (severe psoriasis), Spinraza (SMA) and Aduhelm (AD).
Biogen Inc. Price
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Zacks Rank & Stocks to Consider
Biogen currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A couple of better-ranked biotech stocks are Sesen Bio SESN and Alkermes ALKS. While Sesen Bio sports a Zacks Rank #1, Alkermes carries a Zacks Rank #2 (Buy).
The Zacks Consensus Estimate for Sesen Bio’s 2022 loss has narrowed from 33 cents to 31 cents per share in the past 60 days. Shares of SESN have declined 35.6% in the year-to-date period.
Earnings of Sesen Bio beat estimates in three of the last four quarters and missed the mark on one occasion, the average surprise being 69.94%.
The Zacks Consensus Estimate for Alkermes’ 2022 loss per share has narrowed from 69 cents to 60 cents in the past 60 days. Shares of ALKS have risen 31.3% year to date.
Earnings of Alkermes beat estimates in each of the last four quarters, the average being 362.62%.
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