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Fly News Breaks for February 6, 2020
Feb 6, 2020 | 09:43 EDT
BMO Capital analyst George Farmer raised his price target on Biogen (BIIB) to $317, saying the PTAB decision to toss out Mylan (MYL) claims questioning the validity of Tecfidera '514 patent removes an overhang on the stock. The analyst keeps his Market Perform rating on BIogen, though he sees the potential approval of an eventual aducanumab BLA in Alzheimer's disease still carrying a significant risk.
News For BIIB;MYL From the Last 2 Days
Jul 23, 2021 | 16:32 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
Jul 23, 2021 | 06:27 EDT
RBC Capital analyst Brian Abrahams lowered the firm's price target on Biogen to $341 from $361 and keeps a Sector Perform rating on the shares. The company's base business is performing well but clarity on its aducanumab is "difficult to interpret", the analyst tells investors in a research note. Abrahams adds that adu's processes for P&T, MRI/PET scanning, and reimbursement are all slow and likely to continue to obscure near-term visibility on potential demand and steady-state deliverability.
Jul 22, 2021 | 13:00 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
Jul 22, 2021 | 12:12 EDT
Piper Sandler analyst Christopher Raymond raised the firm's price target on Biogen to $460 from $450 and keeps an Overweight rating on the shares. The company this morning reported a "strong" beat and raise, with the Aduhelm launch remaining front and center during today's update, Raymond tells investors in a research note. The analyst does not expect the negative headlines to subside anytime soon despite Biogen's arguments today, but he continues to think Aduhelm will be used and widely reimbursed. Raymond remains a buyer of Biogen shares.
Jul 22, 2021 | 10:46 EDT
Stifel analyst Paul Matteis lowered the firm's price target on Biogen to $430 from $443 and keeps a Buy rating on the shares following the company's quarterly report and an associated call "dominated by Aducanumab discussion." He is reducing his Aducanumab estimates for 2021 and 2022 to account for his estimates of average price per patient and the NCD reimbursement overhang, which Matteis said seems like it may significantly slow prescriber uptake "to a greater extent than we appreciated."
Jul 22, 2021 | 08:57 EDT
Check out this morning's top movers from around Wall Street, compiled by The Fly.  HIGHER - India Globalization... To see the rest of the story go to See Story Here
Jul 22, 2021 | 07:27 EDT
A letter from Biogen Head of Research and Development, Alfred Sandrock read in part, "On June 7, 2021, ADUHELM became the first approved treatment to address a defining pathology of Alzheimer's disease: targeting the reduction of amyloid plaques in the brain. We believe patients, family members and physicians deserve the facts about the therapy and the process by which it was approved so they may make informed decisions...Unfortunately, ADUHELM's approval has been the subject of extensive misinformation and misunderstanding. It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data. That is how science advances and we welcome these discussions. Recently, however, there has been a turn outside the boundaries of legitimate scientific deliberation. We welcome a formal review into the interactions between the FDA and Biogen on the path to the approval of aducanumab. A better understanding of the facts is good for everyone involved to assure confidence in both the therapy and the process by which it was approved as we prioritize the issues that affect patients. A step toward such transparency is to correct some of the misinformation we have seen...Several people have stated that all previously studied anti-amyloid antibodies clear amyloid from the brain but have failed as a class to demonstrate benefit. This is factually incorrect. First generation anti-amyloid antibodies were not specific for aggregated forms of amyloid beta, or targeted soluble monomeric amyloid beta, or were deficient in effector function. As a result, these antibodies do not clear amyloid from the brain. As such, there is no basis for using the failure of these antibodies as a reason to question the approval of ADUHELM. The review process that led to accelerated approval was extensive and thorough, during which we responded to numerous questions and requests from the FDA. The approval is supported by data of more than 3,000 patients and 2.2 million pages of clinical data and analyses. Separately, we have seen statements that all of ADUHELM's results are "post hoc" - in other words, that a filter was applied after the fact to interpret the data in a certain way. That is also factually incorrect. The primary and secondary endpoints had been pre-specified in the Phase 3 trial protocols, before the first patient was enrolled into the trials. The ADUHELM label shows the results on these pre-specified endpoints, based on data that had already been collected at the sites by the time the trials were prematurely terminated on March 21, 2019. Safety data were also extensively reviewed and are well documented in the label, so that physicians can make informed benefit-risk decisions and take appropriate actions as they monitor their patients under treatment....The FDA's decision to approve ADUHELM to treat patients with Alzheimer's disease was based on thorough analysis of the data...The FDA also stated: "Although the ADUHELM data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that ADUHELM reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients."1 The FDA also shared that it "is requiring Biogen to conduct a post-approval clinical trial to verify the drug's clinical benefit." In the announcement of its decision to approve ADUHELM through its Accelerated Approval pathway, the FDA explained the rigor underlying its analysis: "We examined the clinical trial findings with a fine-tooth comb, we solicited input from the Peripheral and Central Nervous System Drugs Advisory Committee, we listened to the perspectives of the patient community, and we reviewed all relevant data. We ultimately decided to use the Accelerated Approval pathway-a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit. In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of ADUHELM for patients with Alzheimer's disease outweighed the risks of the therapy."..The approval of ADUHELM has already renewed investment activity in Alzheimer's disease research and development, and we are optimistic that other innovative treatments will soon join ADUHELM."
Jul 22, 2021 | 07:08 EDT
FY21 revenue consensus $10.63B. Backs FY21 EPS view of $17.50-$19.00, consensus $18.59. Backs FY21 capital expenditures guidance of $375M-$425M. Biogen said: "This financial guidance continues to assume modest ADUHELM revenue in 2021, ramping thereafter. This guidance also continues to assume erosion of TECFIDERA and RITUXAN in the U.S. Biogen expects the decreased revenue from these high margin products to reduce its gross margin percentage compared to 2020. Non-GAAP R&D expense is expected to be between $2.45 billion and $2.55 billion, an increase from prior guidance primarily due to an expected $125 million upfront payment in the third quarter of 2021 associated with our recently announced collaboration with InnoCare Pharma Limited. This payment was not included in our prior guidance."
Jul 21, 2021 | 13:48 EDT
Notable companies reporting before tomorrow's open, with earnings consensus, include Abbott Laboratories (ABT), consensus $1.02... AT&T (T), consensus 79c... Danaher (DHR), consensus $2.05... Union Pacific (UNP), consensus .$2.50.. Blackstone Group (BX), consensus 77c... Biogen (BIIB), consensus $4.55... D.R. Horton (DHI), consensus $2.81... Southwest Airlines (LUV), consensus (32c)... Fifth Third Bancorp (FITB), consensus 80c... Genuine Parts (GPC), consensus $1.52... Domino's Pizza (DPZ), consensus $2.86... American Airlines (AAL), consensus ($2.41)... Alaska Air (ALK), consensus (73c)... Valley National Bancorp (VLY), consensus 30c.