Biogen Bombs at the FDA Panel; J.P. Morgan Weighs In

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curncman
Posts: 1152
Joined: Fri Jun 26, 2020 8:27 am

Biogen Bombs at the FDA Panel; J.P. Morgan Weighs In

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Biogen Bombs at the FDA Panel; J.P. Morgan Weighs In

https://finance.yahoo.com/news/biogen-b ... 30762.html

TipRanks
TipRanks
Sat, November 7, 2020, 8:07 PM GMT+5:30·3 min read
By a vote of one for, eight against, and two abstaining, the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee concluded Friday that positive clinical data from Biogen's (BIIB) "EMERGE" trial, when "viewed independently and without regard for" data from the company's "ENGAGE" trial, were not sufficient to convince it that aducanumab is an effective treatment for Alzheimer's.

The Advisory Committee furthermore voted zero to seven (with four abstentions) against a finding that Biogen's PRIME study data was any better. And although on the bright side, the committee voted five-to-zero-to-six sort of in favor of the verdict that Biogen has "presented strong evidence of a pharmacodynamic effect of aducanumab on Alzheimer’s disease pathophysiology," in the end, they concluded by a crushing zero-to-10 margin (with one abstention) that it was not reasonable to rely upon the EMERGE data as a reason to approve the drug for commercial sale.

That's the bad news.

The good news is that the Advisory Committee's recommendations above are not binding on the FDA itself, and the FDA could, therefore, end up approving the drug anyway. (The FDA intends to render its own final verdict by March 7, 2021).

But the other bad news is that, when you get right down to it, the Advisory Committee's conclusions were "overwhelmingly negative," as J.P. Morgan analyst Cory Kasimov opined in a note out today. Tallying up the results, points out Kasimov, Biogen garnered a grand total of just "one yet vote across the three key efficacy questions." And this, in the analyst's opinion, "certainly calls into serious question the FDA's very positive stance on aducanumab."

Calling the Advisory Committee's verdicts a "near unanimous vote against aducanumab and strong commentary against the FDA's own analyses," Kasimov warns that "with the FDA's reputation already in a precarious position, it could be difficult -- maybe impossible -- to go against an expert panel at this time no matter how badly they want this."

Which kind of makes the March 7 decision sound like a foregone conclusion, and not one that favors Biogen.

So what does this mean for Biogen and the investors who've placed their faith in it? On the one hand, the aducanumab polls were unqualifiedly bad for Biogen. Still, they apparently weren't quite bad enough to shake JP Morgan's faith in the company so as to necessitate downgrading the stock from "neutral" (the stock's current rating) to "sell." Nor did Kasimov cut his price target on the stock from its present level of $269 per share.

That being said, when you consider that Biogen stock costs nearly $329 a share today, Kasimov's $269 price target does still imply that Biogen stock is worth nearly 19% less than what investors are currently paying for it. (To watch Kasimov's track record, click here)

This stock has attracted plenty of interest from Wall Street’s analysts. BIIB’s analyst consensus rating is a Moderate Buy based on 27 reviews, which include 11 Buys against 14 Holds and 2 Sells. (See BIIB stock analysis on TipRanks)
curncman
Posts: 1152
Joined: Fri Jun 26, 2020 8:27 am

United States nears 10 million coronavirus cases

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United States nears 10 million coronavirus cases
US COVID spike will look like pouring gasoline on a fire, experts say

https://edition.cnn.com/2020/11/08/heal ... index.html

'This chart is just depressing': John King breaks down Covid-19 cases 01:38
(CNN)The United States is hurtling toward yet another grim milestone of 10 million cases, with over 9.9 million reported cases as of Sunday evening, according to Johns Hopkins University data.

The country recorded 100,762 new cases and and 453 new deaths as of 9:30 p.m. ET on Sunday, marking the fifth highest day of new cases in the country since the pandemic began.
US tops 125,000 daily coronavirus infections -- a record high
US tops 125,000 daily coronavirus infections -- a record high
The fall resurgence has brought regular records in cases, people hospitalized and daily deaths -- and experts are encouraging measures to mitigate the spread as they warn that the numbers may continue to climb in coming weeks.
"We're going to see these case numbers really start to explode," former US Food and Drug Administration Commissioner Dr. Scott Gottlieb told CNBC on Friday.
The virus can be dealt with by targeting mitigation state by state, he said, but the US is not doing that currently, and the lack of intervention could build up for the future, spelling trouble for December and January, he said.
"It's not just the cases; it's the hospitalizations as well. That's really the number to watch: 53,000 people hospitalized, 10,500 people in ICUs. That's a lot, and it's growing very quickly."
Sixteen states reported record high Covid-19 hospitalizations Friday, according to the Covid Tracking Project, and 22 states have reported at least one record high day of coronavirus hospitalizations during November, so far.
On Sunday morning, the global number of cases topped 50 million, with the US, India, Brazil and Russia, in that order, the hardest hit, composing more than half the cases, Johns Hopkins reports.
While the total number of cases in the US approaches 10 million, Texas alone is inching toward 1 million cases, with more than 5,000 reported Sunday.
In Oregon, Gov. Kate Brown said Sunday the state has surpassed the "alarming threshold" of 50,000 cases.
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