a:5:{s:8:"template";s:5073:" {{ keyword }}
{{ text }}
";s:4:"text";s:5155:"We are also advancing our ASO-targeting tau BIIB080, which may reduce the synthesis of all forms of the protein, both intracellular and extracellular. Our next question comes from the line of Geoff Meacham with Bank of America. We also continue to develop a broader Alzheimer’s disease portfolio and believe we are well positioned for sustained leadership in this disease area. More: Alzheimer's, dementia and caregiving: 5 ways to manage stress, avoid family strife, More: Napping more? You may begin your conference. I believe that starting earlier is the best approach for - it turns out for all these neurological diseases and so we look forward to seeing the results of that. In terms of the Advisory Committee, it would not be unusual for the first disease modifying therapy of this type to be reviewed at an Advisory Committee. And I've now forgotten the second part of your question. Q2 GAAP other income was $63 million, which included $103 million in unrealized gains on investments, principally driven by an increase in the fair value of our equity investments in Ionis Pharmaceuticals and Sangamo. We anticipate full-year 2020 GAAP diluted earnings per share results of $32 to $34 and non-GAAP diluted earnings per share to be between $34 and $36. Outside the US, our MS revenues were $615 million, a decline of 11% versus the prior year, due in part to a negative effect of foreign exchange rates of approximately $35 million. In addition, we are pursuing what we hope will be transformative approaches in MS. Let me now turn to gross margins. Tau as a biomarker, which in Alzheimer's has really risen in prominence over the last few years. “The results from this early-stage, safety-focused, gene therapy trial for people with XLRP are encouraging, especially given the subjects have advanced retinal degeneration,” says Brian Mansfield, PhD, executive vice president of research and chief scientific officer at the Foundation Fighting Blindness. We believe that Q1 2020 TECFIDERA revenues outside the US included a benefit of approximately $28 million attributed to accelerated sales through the COVID-19 pandemic, of which, we believe approximately $17 million was utilized in Q2 2020. Outside the US, SPINRAZA revenues increased 10% versus the second quarter of 2019, demonstrating strong performance despite the impact of COVID-19, broad growth across all major regions of the world with an increased number of countries contributing as we continue this very successful product launch. Maybe a two-part for me. Great. Biogen also showed results from a subset of patients in the ENGAGE study, who were randomized to the 10 mg/kg high dose of aducanumab, that support the findings from EMERGE. All lines have been placed on mute to prevent any background noise. This submission followed ongoing collaboration with the FDA and includes data from a comprehensive clinical development program, including EMERGE, the first positive Phase III study ever in this space. Let me begin with some important developments. We received one when we got nusinersen approved. So we did support the preclinical study with BAN2401 while we focused on the filing for aducanumab. What I haven't heard you talk about is whether you've requested breakthrough therapy designation, which is arguably a better litmus test for how FDA views the data we have. Second, we are disappointed in the recent court decision in West Virginia regarding our patent for TECFIDERA. We plan to initiate a Phase III program for BIIB059 in the first half of next year. At this time, I would like to welcome everyone to the Biogen Second Quarter 2020 Financial Results and Business Update. You have presented before the submission there of aducanumab various of the patients. So, we'll have to see how all of that plays out. The study concluded the higher-dose aducanamab reduced clinical decline in people in the Emerge study, but the same doses failed in the Engage study. We have seven Phase III and we are very close to open a new page, if FDA allows, with aducanumab. I’ll now turn the call back over to Michel for his closing comments. The March decision to halt the studies was "highly unfortunate and puts us in the situation of interpreting complex data," he said. Biogen to Report Third Quarter 2020 Financial Results October 21, 2020 October 6, 2020 Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11, a Proposed Biosimilar Referencing Lucentis® (ranibizumab) These statements are subject to certain risks and uncertainties and our actual results may differ materially. Hi. And in terms of anti-LINGO, the primary endpoint is the overall response core, which looks - which is a four components score, looking at walking, EDSS and 9-hole Peg Test in the dominant arm and 9-hole Peg Test in a non-dominant arm. We believe that aducanumab marks the beginning of an era of new potential treatment for Alzheimer’s disease, and we aim to build a broad franchise across multiple targets and modalities. We have - we're very excited that our partners at Eisai are initiating this clinical study with the Alzheimer's Disease Clinical Trials Consortium. ";s:7:"keyword";s:14:"biogen results";s:5:"links";s:551:"Aardvark Vs Anteater, Mahaffey Will Call, Rev Left Radio Merch, Amazon Prime Increase 2020, Carrie Underwood Husband, ";s:7:"expired";i:-1;}