Biogen Inc (BIIB)

[McMagyar]

Even if they get approval on
Frankie Docs gonna give time patients to make their head swells for nothing..

Pathetic

[McMagyar]

Repeat..
We are not looking for partners..
Not doing it..

[noretreat]

What is the outlook for Promis as far as getting a partner to advace into trials?

[Doc328]

Promis might very well have a better anti-amyloid antibody. The oligomer is likely the most relevant target. Mice don't get ARIA side effects like humans. Until human studies, we won't know whether ARIA-E are less common with PMN310. Their main problem is lack of cash. They only have about 3 million in cash - do they spend it all on a phase 1?

All large BP's like Biogen will have a competitive intelligence group and they will be aware of all available public information regarding Promis's amyloid and tau antibodies. With a 40 million MC raising additional funds will be difficult and costly to current shareholders. A buyout or partnership is their better bet but that will delay starting a phase 1 in AD patients as cash trickles away.

[Phoenix300]

“Buffett betting on aducanumab? Berkshire Hathaway takes a new stake of 648,000 shares of $BIIB, per 13F filing just out. $BIIB +1.9%”

2/14/2020 tweet from Meg Tirrell


This could affect ARFXF, if approval happens.

[McMagyar]

Terrible news for the sick

[fung_derf]

OK, what the heck is about to happen here?

[Gbathat]

Is biogen looking at Promis Neurosciences PMN310? Similar product, but better specificity and binding affinity than aducanumab. I haven't found comparative studies vs BAN2401, but their website claims lower ARIA-E effects (so you could dose higher and more efficiently). They claim they will start PhI in 2020... we'll see.

The company is tiny, publicly traded, market cap of only $34M. Biogen's stock went up about $15B on marginal PhII aducanumab results, if I recall.

US ticker is ARFXF

https://promisneurosciences.com/

Any dd appreciated, thx.

[McMagyar]

Third shade of red is the charm says Ship of Fools

[mrplmer]

Aducamab is now a pig with lipstick on. Be wise and dump the pig for Anavex. Nuff said

[jonny_red]

Biogen's CTAD Presentation On Aducanumab Elicits Mixed Response

$BIIB

https://www.transparenttradersblackbox.com/post/biogen-s-ctad-presentation-on-aducanumab-elicits-mixed-response-biib

[JSmoove]

Hahaha!

[McMagyar]

But wait Biogen has the cure for Alzheimer’s! Oh no wait..
That is Anavex

[McMagyar]

So you may be asking yourself if Biogen has cured Alzheimers with brilliant new drug Why aren’t we at $400 a share?
The only reason you are asking this question is that you now own Biogen without doing your proper research. No matter how many coats of white paint you put on a turd, and this is the third coat on this turd, when you step in it,
the end result is always the same.

[McMagyar]

“Engage, is still a clear failure. At the high-dose that Biogen is touting, patients who took aducanumab appeared to do worse than those who took a placebo on a key measure even with the new data. That’s tough to explain away, though Biogen is certainly trying. “

[McMagyar]

That Phase I trial started with 165 participants, 32 of which received the higher dose. Of those, 15 developed ARIA-E, and 10 patients dropped out of the study because of adverse events, a troubling sign.”

As a percentage.. not good

[McMagyar]

Anyone want to wager?
Biogen raises some funds Before Dec?

[McMagyar]

You let them do it to you again with the same failed drug?
You deserve what’s coming.
All this money could have gone to really help people.

[McMagyar]

With a major breakthrough in mankind’s biggest disease the chief
Medical researcher moves on tons start up? Haha.. yeah that happened..maybe he had a Dream..

Like get the hell out of a company that keeps billing wanton investors out of BBBBillions of dollars by planting beautiful pictures and creating false hope when all the while their medicine has NONE..

Maybe with Anavex Blarcamesine as an Adjuvant..down the road..
Maybe that’s the plan..

Get addufakethemout approved then tag team Blarcamesine..

Dec data will crash this party hard

[McMagyar]

Wonder why BIIB MICHAEL Ehlers stepped down from Biogen Oct 11?

One person at Biogen has some effing integrity.
One

[McMagyar]

Don’t believe in betting against people tryin g to help other people
But I don’t believe for a second that is what this fake revival is about..

How much more money will now be poured down this drain to dementia death?

Billions? Yep. Billions!

You know how many people it will stop from dying of Alzheimers ?


ZERO. ZERO.

[McMagyar]

Pradaxa does more in the Mouse model for AD than brain swell aduscamabob

[McMagyar]

Make your money before they publish this combed over
Ridiculous risk reward data in December!

You gotta another month to scam everyone out of their money before their brains swell with anger at being ripped and lied too YET AGAIN!

Does anyone care that none of this is stopping or reversing Alzheimers?


Anavex NOW

[McMagyar]

I am going all in on Biogen!
Now it works! We swear!
Even the FDA agrees!
It’s better than OPIUM, Heroin
And Fentynol! No one expects anyone to survive anyway!


And the beat goes on..

Aduscamaramabutt
What should be the company logo?
We can’t do high doses because it
Makes your head swell
It works at high doses!

Ain’t working of your Head don’t swell?

WTH

[McMagyar]

Last two times it took about a month

[Greenspam3]

"I would recommend selling shares in Biogen before the data catches up with the claims.
Biogen is engaged in a numbers game. Its new CEO is trying to resurrect a failed drug based on a largely wrong hypothesis. In the short term, investors have seemed to have gone for the bait again. For those who held onto the stock after the first futility analysis, you have temporarily done quite well. But it is not good to be greedy. Biogen is likely headed back to the low 200s. The question is how long will it take." according to Lane Simonian in Seeking Alpha

[Greenspam3]

https://seekingalpha.com/article/4298721-biogen-amyloid-alzheimers-disease-rabbit-hole?isDirectRoadblock=true

[McMagyar]

Look at Pradaxa animal testing.
Anticoagulant is better chance of helping your dad. Also S1r Agonist ..many already approved..(DM)
Choline is natural 1r
Curcumin is natural anticoagulant...

[Danorocket]

Going to short the shit out of this Cramer is an pump goof ball

[McMagyar]

Stealing money from ACTUAL drugs that may work ..
S1r Agonist Anavex- Blarcamesine..
S2r Agonist
Nicotine receptor Agonist

Et al.....

Base is not the answer but maybe as adjuvant...always hope..

But not this hype

[McMagyar]

Who is going to risk brain swelling for one more month of lucidity?

No one..


No one is going to risk brain swelling if they have half a brain.

What is your target market then?

ZERO

[McMagyar]

Madoff working it from his cell

[conix]

Biogen Reverses Take on Aducanumab Trial Data

— Says reanalysis shows anti-amyloid drug is a winner for Alzheimer's disease

by Judy George, Senior Staff Writer, MedPage Today October 22, 2019


Aducanumab over an illustration of colorful brain synapses with the Biogen logo in the bottom right corner
Biogen surprised the Alzheimer's disease community this morning when it announced plans to pursue regulatory approval for aducanumab, its investigational monoclonal antibody targeting beta-amyloid protein in early Alzheimer's disease.

Earlier this year, Biogen and partner Eisai terminated their phase III trials of aducanumab after interim analyses indicated the drug was ineffective.

But today, Biogen said a "new analysis of larger dataset showed that aducanumab reduced clinical decline in patients with early Alzheimer's disease as measured by the pre-specified primary and secondary endpoints," and based on discussions with the FDA, the company plans to submit its application to the FDA in early 2020.


The EMERGE and ENGAGE trials of aducanumab were stopped in March based on a pre-specified futility analysis that relied on early data of 1,748 patients who completed the 18-month study period, the company explained. Since then, a larger dataset of 3,285 patients became available; of these, 2,066 patients completed the full 18 months of treatment.

A new analysis of this larger dataset showed a different outcome from what the futility analysis predicted. The EMERGE trial showed statistically significant results on the pre-specified primary endpoint of clinical decline from baseline in Clinical Dementia Rating-Sum of Boxes scores at 78 weeks of 23% versus placebo (P=0.01).

The ENGAGE trial did not meet its primary endpoint. Biogen said, however, that it "believes that data from a subset of ENGAGE support the findings from EMERGE," and the problem with ENGAGE was that fewer patients received a high dose of aducanumab because the study started earlier.


What this new data means is a question of controversy: while investors were positive this morning, skeptics voiced concerns over inconsistencies in the new data, both within the ENGAGE study and comparisons between the two trials.

The ENGAGE trial, for example, showed worse symptoms and faster decline in patients who received the high dose of the drug versus placebo. The low-dose group performed better than the high-dose group in some measures. And neither trial reported data in absolute terms that would shed light on the findings' clinical significance.

Biogen was also cagey about safety, saying only that the drug's adverse-event profile in the two trials was "consistent with previous studies of aducanumab," but provided no details for the newly enlarged high-dose groups.

"The bottom line is they ran two parallel trials, and one was positive and one was negative," said Ron Petersen, MD, PhD, of the Mayo Clinic, who has consulted for Biogen but was not a trial investigator. "The million dollar question is why."


Changing the ENGAGE study protocol allowed more patients who were APOE4 carriers to be allocated to the high-dose group, Petersen told MedPage Today. "When they analyzed the subgroup of patients in the failed study who had had adequate exposure to the high dose of the drug for an adequate period of time, those data looked like the data from the positive study," he said. "That's what they're hanging their hat on."

"Finally, we see something that's working for Alzheimer's," noted Zaven Khachaturian, PhD, editor-in-chief of Alzheimer's & Dementia.

The data so far "looks pretty impressive," but Biogen only released the "show-and-tell for investors" and not details, Khachaturian told MedPage Today. "If the findings hold, that would be great," he said. "Even if it works on a small subset of patients, it is good news. Given the heterogeneity of the disease, it would be unreasonable to expect that it would work on every Alzheimer's case."


But whether the FDA will require another study is unknown: "Typically, FDA requires two pivotal studies," Khachaturian said. "Given the fact that Alzheimer's is such a national problem, they might overlook that and go along with just the data from these trials."

Like other clinicians and researchers on Tuesday, Eric Reiman, MD, of Banner Health in Phoenix, expressed cautious optimism. "We need to see the data presented to better understand the full implications," Reiman told MedPage Today. "But this news provides a shot in arm at the right time for amyloid-focused research, giving hope to those currently impacted by this terrible disease as we actively explore implications for future prevention trials."

Biogen plans to present data from the trials at the Clinical Trials on Alzheimer's Disease meeting in December 2019.

If approved, aducanumab would become the first drug to reduce the clinical decline of Alzheimer's disease and the first to show that removing beta-amyloid burden led to better clinical outcomes.

[Bourbon_on_my_cornflakes]

BIIB orchestrates a $20 billion pumpndump

Even pays Cramer to pump the stock. Classic.

That has got to be some sort of record.

[McMagyar]

biogen has so many sheisters to thank for tis pump..where do you start..?? how many doctors and clinicians know that this entire episode is crap? ALL OF THEM..Biogen has ZERO reputation just greed.

another 25 Buillion going to be lost to the FOOLS..already lost $70 Billion on Biogen Pumps..this one will be a bit cheaper..

Who gets to keep all this money when they sell their stock and it goes back down? why Copr Officers and large stakeholders..that is WHO..Who Losess? why investment funds and your retirement ..Good Bye//
Hey DO YOU REMEMBER THAT?

JUST Go get your brain swelled than you will remember..

[fr1ends4ever]

caution, it inflames at higher doses. and inflammation can be dangerous. can they prevent it? and fda would be crazy to approve without a retrial. they stopped the retrial prematurely and now they’ll have to redo it all over again

[conix]

No--not short. Nor long.

Just being a little snarky about the conspiracy theory being proposed.

With a father suffering from Alzheimer's, I am hopeful that this drug can help and get approved.

[Bourbon_on_my_cornflakes]

Short on the news, not before.

Today is the day to short if you are so inclined. Should not have been short before.

[semi_infinite]

IMO most shorts had covered already after the prior data reveal. I have no dog in this fight but it does look like something subjectively good happens at high dose. Is it good enough and how many patients will benefit are questions. Given your comments, I assume you are looking to short or already is.

[conix]

I, too, feel for all the shorters in BIIB.

[Bourbon_on_my_cornflakes]

The perfect heist by BIIB mgt.

All those stock options under water, and bonuses that would not be paid, because the stock tanked when aducanumab was pulled.

So what to do?

Revive the effort near year-end bonus time and pump up the stock.

Fat bonuses get paid, stock options get cashed in.

Then mgt just blames the FDA when aducanumab gets rejected next May.

The perfect heist, makes Ocean's 11 look like amatuers.

[fung_derf]

Halleluiah!

[conix]

Biogen Up 30% on Alzheimer’s drug revival: ‘It would be the biggest drug ever,’ Cramer says

Biogen announced it is seeking regulatory approval for its Alzheimer’s drug, aducanumab, months after it stopped testing the treatment.
The stock erased its entire 25% year-to-date decline on Tuesday.
“It would be the biggest drug ever,” said CNBC’s Jim Cramer on “Squawk on the Street.”

Cramer: Biogen’s Alzheimer’s treatment would be ‘the biggest drug ever’
Shares of Biogen soared 30% on Tuesday after the drug maker said it is seeking regulatory approval for its Alzheimer’s drug, aducanumab.

“It would be the biggest drug ever,” said CNBC’s Jim Cramer on “Squawk on the Street.”



The announcement comes just months after Biogen discontinued clinical studies for the same drug following a data analysis that did not achieve its objective. Shares of Biogen sold off in March after stopping the trials as Wall Street was expecting this drug to be Biogen’s next big source of revenue.

Biogen erased its entire 25% year-to-date decline when it said a new analysis of a larger dataset showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease,” the company said in a release. Patients who received the drug “experienced significant benefits on measures of cognition and function such as memory, orientation, and language.”

Biogen plans to file for approval with the FDA in early 2020.

“With such a devastating disease that affects tens of millions worldwide, today’s announcement is truly heartening in the fight against Alzheimer’s,” said Michel Vounatsos, Chief Executive Officer at Biogen in the release. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta.”

“You have the number one drug of all time, potentially,” said Cramer.

While Alzheimer’s effects about 50 million people globally, there are no approved therapies to slow or reverse the decline of the disease.

“The whole concept of senior living will change,” added Cramer. “You know whose going to take this drug?” asked Cramer. “Everyone.”

Before the announcement, Biogen reported third-quarter earnings that topped Wall Streets’ expectations. Profit rose 7.1%, boosted by higher demand for its rare muscle drug Spinraza and total revenue rose about 5%.

The drug maker reported earnings per share of $9.17 on revenue of $3.60 billion. Analysts had forecast earnings of $8.27 per share on revenue of $3.539 billion.

[fr1ends4ever]

BIIB stops both Elenbecestat and BAN2401 prematurely, stating too much risk... I believe (but I may be wrong) these were the last of BACE inhibitor trials...

What made them lose heart, despite II trials saying it was showing cognitive benefit?

[Biobillionair]

BIIB needs to look at this ALZ Rx. candidate: https://clinicaltrials.gov/ct2/show/NCT02719327?term=vascepa&rank=4

BIIB should partner with AMRN on ALZ.

BB

[starkd748]

Trend is down here from its 3yr high

[growacet]

Obviously there's a HUGE value for an AD treatment....

That $16 billion hit the Mcap took here shows how much value the market places on even a potential treatment for Alzehimer's disease.

There's a Phase 3 trial going on by a Canadian Biotech that's very much below the radar, and cognition is one of the secondary endpoints that they're measuring on patients over 70 years of age, many of whom have MOCA scores below 25, indicative of cognitive impairment.

This is a SA blog post about them which mentions Biogen and failed AD drug Aducanumab.

https://seekingalpha.com/instablog/15663412-joe_retail/5302150-resverlogix-keeps-climbing-high-can-go

[Lazarus]

Added more this am....

I'll stay in as long as it stays in the circle

[tw0122]

US Citizens can now buy Biogens Avonex for $5,000 less in Mexico. Prescription in US $7,000 aprox. in Mexico $2,000 aprox.

[tw0122]

Cheaper drug in Mexico by thousands of dollars. Utah state employees will get some relief from insane prescription drug prices, with their insurer’s offer to fund their travel costs to Mexico and to throw in $500 cash, because it's still cheaper than buying the drugs in the US.
The unusual offer is being presented by PEHP, which insures 160,000 state employees and their family members. It includes a flight to San Diego, transportation to a "top notch" clinic in the Mexican border city of Tijuana, and an extra $500 per trip taken (up to $3,900 a year).


Although that seems like a lot of money coming out of PEHP's pocket, it's still apparently less than what it would pay for certain drugs in the US, shining a not-so-pleasant light on America's much scrutinized healthcare system.

“That money is pretty small in comparison to the difference between US prices and Mexico prices,” PEHP clinical operations director Travis Tolley told The Salt Lake Tribune.

The insurance provider came up with its "pharmacy tourism" plan after Utah legislation made it a requirement that state employees' insurance plans offer "savings rewards" or cash incentives to patients who choose cheaper medication providers.


The plan only applies to about 13 drugs, all of which show a huge price discrepancy when their cost in the US is compared with their cost in Mexico. A quick side-by-side glance at Avonex, used to treat Multiple Sclerosis, makes that clear. The drug is about $6,700 for a 28-day supply in the US, but $2,200 through PEHP's contracted clinic in Tijuana.

Other drugs in the program include ones used to treat rheumatoid arthritis, osteoporosis, psoriasis, and prostate cancer.

The plan has been hailed by Utah Rep. Norm Thurston, a Republican who sponsored the legislation calling for incentives. “Why wouldn’t we pay $300 to go to San Diego, drive across to Mexico and save the system tens of thousands of dollars? If it can be done safely, we should be all over that," he said.

The incentive comes as Donald Trump's administration highlights the disparity between drugs in the US and other parts of the world. It has proposed a plan which would focus on the price of drugs under Medicare Part B, which covers cancer drugs and other medications given to patients in hospitals.