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BIIB

Biogen

$384.00

11.2 (3.00%)

16:52
07/25/18
07/25
16:52
07/25/18
16:52

Biogen announces results from Phase 2 BAN2401 study

Eisai and Biogen announced detailed results from the Phase II study, Study 201, with BAN2401, an anti-amyloid beta, or Ass, protofibril antibody, in 856 patients with early Alzheimer's disease. Study 201 is a placebo-controlled, double-blind, parallel-group, randomized Phase II clinical study in 856 patients with mild cognitive impairment, or MCI, due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid pathology in the brain. Patients were randomized to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly, or placebo. This study used a Bayesian Adaptive Randomization Design to automatically allocate newly enrolled patients into the study to treatment arms showing higher probability of efficacy based on the results of interim analyses. The study assessed changes from baseline to 18 months in biomarkers measuring the underlying disease pathophysiology, including changes in amyloid accumulated in the brain as measured by amyloid PET. The clinical endpoints of Alzheimer's Disease Composite Score, or ADCOMS, Alzheimer's Disease Assessment Scale-cognitive subscale and Clinical Dementia Rating Sum of Boxes were also assessed from baseline to 18 months of treatment. Through Bayesian interim analyses, the highest doses of 10 mg/kg monthly and 10 mg/kg biweekly were determined to be the treatment dosages with higher efficacy early in the trial, and as a result, the proportion of patients allocated to these treatment arms was greater. Following a regulatory request in July 2014, the allocation of APOE4 carriers to the 10 mg/kg biweekly treatment arm was restricted, resulting in fewer APOE4 carriers in this arm and more patients being allocated to the 10 mg/kg monthly treatment arm. BAN2401 demonstrated a dose-dependent reduction in amyloid plaques as measured by amyloid PET, and this reduction was statistically significant at all doses. At the highest dose of BAN2401, an analysis of amyloid accumulated in the brain using standardized PET as measured on the Centiloid scale showed an observed mean at baseline of 74.5 and at 18 months of 5.5. Using a Mixed-effects Model with Repeated Measures (MMRM), the mean reduction in amyloid load was 70 units, which was statistically significant. In amyloid PET image visual read, BAN2401 demonstrated a dose dependent conversion from amyloid positive to negative, and at the highest dose, 81% of patients converted from amyloid positive to negative at 18 months. Conventional statistical methods on predefined clinical endpoints at the 18 month final efficacy time point confirmed a dose-dependent slowing in cognitive decline from baseline on ADCOMS. The highest treatment dose of 10 mg/kg biweekly demonstrated a statistically significant slowing of clinical decline of 30% compared to placebo at 18 months. A statistically significant slowing of decline on ADCOMS was observed as early as 6 months as well as at 12 months. Dose-dependent slowing in cognitive decline from baseline on ADAS-Cog was also observed for BAN2401, with the highest treatment dose of BAN2401 demonstrating a significant slowing of clinical decline compared to placebo at 18 months. Furthermore, dose-dependent slowing in cognitive decline from baseline on CDR-SB was observed, surpassing the pre-specified difference of 25% over the duration of the study. At 18 months, slowing of clinical decline for the highest treatment dose of BAN2401 compared to placebo on CDR-SB was 26%. The rate of clinical decline for the placebo group was consistent with the results of research by the Alzheimer's Disease Neuroimaging Initiative in the United States. In a Bayesian analysis of ADCOMS at 12 months, the estimated probability that the highest dose of BAN2401 slows clinical decline more than placebo was 98%. While the criteria for early success at 12 months was pre-specified as an 80% or higher estimated probability of demonstrating a clinically significant difference from baseline compared to placebo, the actual probability for this criteria was 64% according to Bayesian analysis. BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration. The incidence rate of treatment-related adverse events was 26.5% for the placebo arm, 53.4% for the 10 mg/kg monthly treatment arm and 47.2% for the 10 mg/kg biweekly treatment arm. The most common treatment emergent adverse events were Amyloid Related Imaging Abnormalities, or ARIA, and infusion-related reactions. Incidence of ARIA-E was 9.9% at the highest treatment dose, and not more than 10% in any of the treatment arms. Incidence of ARIA-E in APOE4 carriers was 14.6% at the highest dose. Per protocol, all patients presenting with ARIA-E on MRI were discontinued in the study. The incidence rate of serious adverse events was 17.6% for the placebo arm, 12.3% for the 10 mg/kg monthly treatment arm and 15.5% for the 10 mg/kg biweekly arm.

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BIIB Biogen
$384.00

11.2 (3.00%)

07/24/18
PIPR
07/24/18
NO CHANGE
Target $400
PIPR
Overweight
Piper raises Biogen target to $400 after BAN2401 'stole the show' from earnings
Piper Jaffray analyst Christopher Raymond raised his price target on Biogen to $400 from $365 after "solid" Q2 results that he said were overshadowed by what "investors are interpreting as highly encouraging commentary" regarding the BAN2401 data that will be presented at tomorrow's AAIC meeting. Given what he sees as the "massive stock re-rating potential" associated with a viable Alzheimer's treatment, he thinks investors should continue to own the stock into tomorrow's BAN2401 data and ahead of full Phase 3 data for aducanumab in 2020. Raymond keeps an Overweight rating on Biogen shares.
07/24/18
JPMS
07/24/18
NO CHANGE
Target $445
JPMS
Overweight
JPMorgan expects 'FOMO' trading for Biogen, ups price target to $445
JPMorgan analyst Cory Kasimov said Biogen's "nice beat-and-raise" report was "an encouraging start" to the Q2 earnings season, adding that its MS franchise remains largely stable. Much of the conference call Q&A focused on Alzheimer's ahead of tomorrow's BAN2401 data presentation and he thought the overall tone of the conversation was "constructive," he tells investors. The analyst, who thinks a significant "fear of missing out" trade may take hold as the highly anticipated aducanumab data readout in early 2020 approaches, raised his price target on Biogen to $445 from $400 and keeps an Overweight rating on the shares.
07/25/18
ADAM
07/25/18
NO CHANGE
Target $396
ADAM
Buy
Biogen risk/reward positive into Alzheimer's conference, says Canaccord
Canaccord analyst Sumant Kulkarni noted Biogen reported better than expected Q2 results, which were driven by robust Spinraza sales, higher gross margins, and lower R&D expenses. The analyst said the focus is now on the company's BAN2401 presentation at the Alzheimer conference. He said he likes the risk/reward heading into this event. Kulkarni reiterated his Buy rating and $396 price target on Biogen shares.
07/25/18
RHCO
07/25/18
NO CHANGE
Target $392
RHCO
Buy
Biogen price target raised to $392 from $321 at SunTrust
SunTrust analyst Yatin Suneja raised his price target on Biogen to $392 and kept his Buy rating after its Q2 results, saying all key business segments contributed to a top-line beat, while lower cost of goods sold and R&D expenses drove the better than expected earnings. The analyst notes that investors are now focusing on the upcoming release regarding BAN2401 Alzheimer's data, estimating a 20% cognition improvement. Suneja also increased his FY19 expected EPS multiple to 14-times from 12-times as part of his price target revision.

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PLD

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PLD

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PUGOY

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