Interesting one to watch with CNBC article today,
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Posted On: 12/02/2019 10:15:50 PM
Interesting one to watch with CNBC article today, because it looks at least to me at quick glance they are getting similar results to the Nash drug going up for approval in another unmet need area.
Biogen’s stock could fall 10% on new Alzheimer’s drug data this week, top analyst says
https://investors.biogen.com/news-releases/ne...rs-disease
Biogen’s stock could fall as much as 10% once it releases new data this week on its Alzheimer’s drug, aducanumab, Baird biotech analyst Brian Skorney told CNBC on Monday.
The stock could fall even further from its Monday per-share price of around $292 to about $230 if investors believe its drug will be rejected by the Food and Drug Administration, Skorney said on CNBC’s “Power Lunch.”
Shares of Biogen were down more than 2% in intraday trading Monday after Skorney wrote in a note to investors that he is skeptical Biogen’s Alzheimer’s drug will be approved by federal regulators.
“The bottom line is, the FDA standard of approval is substantial evidence of efficacy and the cumulative data for aducanumab falls really far short of this standard,” he said in the note dated Dec. 2.
https://investors.biogen.com/news-releases/ne...rs-disease
In EMERGE, which met its pre-specified primary endpoint in the new analysis, patients treated with high dose aducanumab showed a significant reduction of clinical decline from baseline in CDR-SB scores at 78 weeks (23% versus placebo, P=0.01). In EMERGE, patients treated with high dose aducanumab also showed a consistent reduction of clinical decline as measured by the pre-specified secondary endpoints: the Mini-Mental State Examination (MMSE; 15% versus placebo, P=0.06), the AD Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13; 27% versus placebo, P=0.01), and the AD Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI; 40% versus placebo, P=0.001). Imaging of amyloid plaque deposition in EMERGE demonstrated that amyloid plaque burden was reduced with low and high dose aducanumab compared to placebo at 26 and 78 weeks (P<0.001). Additional biomarker data of tau levels in the cerebrospinal fluid supported these clinical findings. Biogen believes that data from patients in ENGAGE who achieved sufficient exposure to high dose aducanumab supported the findings of EMERGE.
Biogen’s stock could fall 10% on new Alzheimer’s drug data this week, top analyst says
https://investors.biogen.com/news-releases/ne...rs-disease
Biogen’s stock could fall as much as 10% once it releases new data this week on its Alzheimer’s drug, aducanumab, Baird biotech analyst Brian Skorney told CNBC on Monday.
The stock could fall even further from its Monday per-share price of around $292 to about $230 if investors believe its drug will be rejected by the Food and Drug Administration, Skorney said on CNBC’s “Power Lunch.”
Shares of Biogen were down more than 2% in intraday trading Monday after Skorney wrote in a note to investors that he is skeptical Biogen’s Alzheimer’s drug will be approved by federal regulators.
“The bottom line is, the FDA standard of approval is substantial evidence of efficacy and the cumulative data for aducanumab falls really far short of this standard,” he said in the note dated Dec. 2.
https://investors.biogen.com/news-releases/ne...rs-disease
In EMERGE, which met its pre-specified primary endpoint in the new analysis, patients treated with high dose aducanumab showed a significant reduction of clinical decline from baseline in CDR-SB scores at 78 weeks (23% versus placebo, P=0.01). In EMERGE, patients treated with high dose aducanumab also showed a consistent reduction of clinical decline as measured by the pre-specified secondary endpoints: the Mini-Mental State Examination (MMSE; 15% versus placebo, P=0.06), the AD Assessment Scale-Cognitive Subscale 13 Items (ADAS-Cog 13; 27% versus placebo, P=0.01), and the AD Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (ADCS-ADL-MCI; 40% versus placebo, P=0.001). Imaging of amyloid plaque deposition in EMERGE demonstrated that amyloid plaque burden was reduced with low and high dose aducanumab compared to placebo at 26 and 78 weeks (P<0.001). Additional biomarker data of tau levels in the cerebrospinal fluid supported these clinical findings. Biogen believes that data from patients in ENGAGE who achieved sufficient exposure to high dose aducanumab supported the findings of EMERGE.
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