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Fly News Breaks for February 10, 2020
Feb 10, 2020 | 12:18 EDT
William Blair analyst Matt Phipps noted that Eli Lilly (LLY) and Roche (RHHBY) announced that the Dominantly Inherited Alzheimer's Network Trials Unit, or "DIAN-TU," study of solanezumab and gantenerumab in patients with or at-risk for autosomal dominant Alzheimer's disease did not meet its primary endpoint, which he sees as "discouraging for the amyloid hypothesis of Alzheimer's disease." However, Phipps believe the effect on sentiment toward Biogen's (BIIB) aducanumab will be minimal given that the FDA review will come down to the regulator's interpretation of the subgroup analysis from the ENGAGE and EMERGE trials as well as "any political pressures that come into play." Phipps, who does not believe aducanumab will be approved on this review, but admits that "political pressures for devastating diseases with no alternative therapies have led to FDA approvals based on less-than-perfect clinical data packages," keeps a Market Perform rating on Biogen shares.
News For RHHBY;LLY;BIIB From the Last 2 Days
Sep 22, 2021 | 16:28 EDT
Get caught up quickly on the top news and calls moving stocks with these Top Fives, as compiled by the editors of The Fly. 1... To see the rest of the story go to See Story Here
Sep 22, 2021 | 13:12 EDT
Get caught up quickly on the top news and calls moving stocks with these Top Fives, as compiled by the editors of The Fly.  1... To see the rest of the story go to See Story Here
Sep 22, 2021 | 07:41 EDT
Biogen is considering cost-cutting measures, including layoffs, as the launch of its Alzheimer's disease treatment Aduhelm is "far bleaker than what it has publicly disclosed," Damian Garde and Adam Feuerstein report, citing a person with knowledge of the situation. Just over 100 Alzheimer's patients had been infused with Aduhelm as of September 11, Garde and Feuerstein say. While the number is rising slowly, it is drastically below both Biogen's internal projections and Wall Street's expectation that thousands would be using the drug by now, they add. Shares of Biogen are down 4% to $248.99 in premarket trading following the report. Reference Link
Sep 21, 2021 | 08:40 EDT
Biogen will hold a virtual Investor R&D Day, providing a comprehensive overview of the company's diversified pipeline in neuroscience. Biogen plans to advance innovative therapies for patients through the work of its world-class researchers and the strength of its global network of collaborators. As part of R&D Day, Biogen's scientific leaders will discuss ongoing research and highlight key advancements among Biogen's 33 clinical programs, including 12 programs in Phase 3 or filed. Biogen will present an overview of its Alzheimer's disease pipeline with the recent FDA-approved ADUHELM serving as the foundation of a multi-target, multi-modality Alzheimer's disease franchise. In addition to ADUHELM, the company will present progress on lecanemab, a new amyloid beta-directed antibody therapy in Phase 3 being developed by Eisai in collaboration with Biogen, and BIIB080, a tau-directed antisense oligonucleotide. Lecanemab received Breakthrough Therapy designation from the FDA in June 2021. In clinical studies, lecanemab has shown potential to slow clinical decline in Alzheimer's disease and is now being studied in patients with early Alzheimer's disease as well as the preclinical setting, when individuals are clinically normal and have intermediate or elevated levels of amyloid in their brains. A Phase 1b study of BIIB080 met the primary objective of safety and tolerability, and demonstrated a durable time and dose dependent reduction of tau protein in cerebrospinal fluid. Growing evidence suggests tau may be a key driver of neurodegeneration in Alzheimer's disease. In neuropsychiatry, Biogen and Sage Therapeutics are co-developing zuranolone, and will present an overview of the two-week, once-daily drug being studied in major depressive disorder and postpartum depression. Zuranolone has demonstrated positive Phase 3 results. In clinical trials, zuranolone, which represents a potential new class of drug, demonstrated rapid-acting efficacy and was generally well-tolerated. Beyond MDD and PPD, zuranolone may have potential for development in other psychiatric disorders, including treatment-resistant depression, bipolar disorder, and generalized anxiety disorder. Major depressive disorder is a common comorbidity of multiple neurological disorders in Biogen's core therapeutic areas. Biogen will also present an overview of BIIB104, currently under investigation in a Phase 2 study for cognitive impairment associated with schizophrenia. Biogen has multiple ALS assets in development, which target both genetic subtypes of ALS and the broader population. Tofersen, developed in collaboration with Ionis Pharmaceuticals, is currently in Phase 3 studies. The program targets SOD1, a gene believed to be a genetic driver of disease in two percent of all ALS cases. In the recently announced ATLAS study, Biogen will be exploring the use of tofersen prior to symptoms in SOD1 carriers with the intent to delay or slow the decline in function associated with ALS. Based on learnings from the company's prior and ongoing trials, Biogen is also advancing BIIB078, an ASO targeting C9orf72, another potential genetic driver of ALS, and BIIB105, an ASO targeting ATXN2, a potential treatment for ALS in the broader population supported by human genetics. Biogen is progressing its research in the treatment of stroke. The potential to expand the stroke treatment window has been shown in positive proof of concept studies for BIIB131, a next generation thrombolytic agent, and BIIB093, a treatment for brain swelling in large hemispheric infarctions. BIIB131, a treatment for acute ischemic stroke, was recently acquired based on positive Phase 2 data. BIIB093 is in a Phase 3 study for large hemispheric infarction, and a Phase 2 trial for lesion expansion in brain contusion. Decades of study by Biogen at the intersection of neurological and immunological pathways provide the company with expertise in immunology. Biogen is advancing two lupus therapies in Phase 3 trials. Dapirolizumab pegol is being developed in collaboration with UCB for systemic lupus erythematosus . The second, BIIB059, was fully developed in-house at Biogen and is now in Phase 3 for SLE, with plans for further study in cutaneous lupus erythematosus. In April 2021, the company formed Biogen Digital Health, a global unit that aspires to transform patients' lives and Biogen by making personalized and digital medicine in neuroscience a reality. In an on-demand presentation, Biogen Digital Health will share key areas of focus and highlights, including progress on digital biomarkers and efforts to develop deep-learning software.
Sep 21, 2021 | 06:12 EDT
Apple (AAPL) is working to develop technology that will help diagnose depression and cognitive decline, Rolfe Winkler of The Wall Street Journal reports. Using an array of sensor data, such as mobility, sleep activity, etc., researchers hope to utilize digital signals associated with target conditions so algorithms can be created to reliably detect them, the sources told the Journal. These efforts spring from Apple's research partnerships with the University of California, which is studying stress, anxiety and depression, as well as with Biogen (BIIB), which is studying mild cognitive impairment. Reference Link