Category: BIIB

BIIB – Will Biogen Be Able to Move Past the Drama Surrounding Its Alzheimer's Disease Drug?

Biogen‘s (NASDAQ:BIIB) history so far with Alzheimer’s disease drug Aduhelm is like a biotech soap opera. In this Motley Fool Live video, recorded on July 19, 2021, healthcare and cannabis bureau chief Corinne Cardina and Motley Fool contributor Keith Speights discuss whether the company will be able to move past all of the drama surrounding its controversial drug.

Corinne Cardina: Let’s dig into the Biogen issue a little bit more. We’ve talked about the FDA issue. Basically, FDA approved Biogen’s somewhat controversial Alzheimer’s drug.

I’m sure you and Brian have talked about that in depth. But here is the latest. Some private insurers has said they’re not going to cover it. Medicare is doing some review to look into when the government would be willing to pay for it. They set the price around $50,000 annually.

And then acting FDA Commissioner Janet Woodcock actually publicly acknowledged that the agency could have handled it better. She was asked a question and she didn’t totally defend exactly what happened where the FDA went against the Advisory Committee’s thumbs down. Some of the Advisory Committee members actually resigned, upset about this.

What is the latest, Keith, with what investors should know about Biogen? Obviously, the stock went up after the drug was approved. But now it’s starting to get a little bit hazy in terms of, is anyone actually going to be prescribed this drug and have it covered by some payer?

Keith Speights: Yeah. Corinne, I think you were very diplomatic when you said that this approval was “somewhat” controversial. [laughs] This approval, it kicked the hornet’s nest. This has been as close to a soap opera as you’re going to find in the biotech world.

Let’s go back to 2019 very quickly. Biogen had practically thrown in the towel on this drug after it flopped in late-stage clinical testing. It was considered just dead, basically.

Then it’s nearly like the phoenix from Greek mythology. The drug, which was then called aducanumab, it rose from the ashes. Biogen, several months after seemingly throwing in the towel, parsed through its clinical data and found a potential path to approval. And investors cheered, but a lot of folks were skeptical. They were thinking, “Yeah, right. This thing is not going to get approved.”

You mentioned some of the fireworks that have exploded since the Advisory Committee voted overwhelmingly against approval. The FDA approved the drug anyway. Several of the members of that advisory committee resigned in protest. You mentioned the investigation that has been called as to whether or not the FDA staff had improper contacts with Biogen during the review process.

This is just a big mess, basically. As you mentioned, there also are reports that healthcare providers are stating they won’t prescribe Aduhelm. At least half a dozen — so far — Blue Cross Blue Shield plans are saying they won’t cover this drug, and it could get worse from there. A lot of drama. Like I said, a biotech soap opera.

Even with all of this, I fully expect that Aduhelm is going to generate billions of dollars in sales for Biogen. I think this is highly controversial. There are a lot of folks taking sides. A lot of doctors won’t recommend or won’t prescribe the drug. A lot of payers may not cover it, but Medicare will and there’ll be plenty of doctors who will prescribe it because there really aren’t any other approved treatments that they can go to for Alzheimer’s disease. Even though they might be skeptical as to whether or not Aduhelm works, I think you’re going to see a lot of doctors prescribe it because the patients are going to want it.

So I think Biogen is going to make a lot of money off this thing despite the controversy. It is important to note, though, that Biogen has some challenges on its hands. It’s sales of its bread-and-butter, multiple sclerosis franchise are declining, sales of its final muscular atrophy drug Spinraza are falling, and so Biogen really needs this. And I think again, this is a mess, but Biogen is going to make a ton of money.

Cardina: Yeah, absolutely. In the regulatory process, the patients and the patients’ families and the advocates in the Alzheimer’s and dementia community, they don’t have that many options. This is not a cure drug. It purportedly delays the progression of the disease, and so there’s going to be a ton of patients and families out there who want to try it. They’re trying everything, and so I think you’re totally right about that.

We’ll have to keep an eye on it. It’s going to be very interesting to see if Biogen is successful in commercializing this. They definitely don’t have an easy path ahead of them, so we will definitely keep an eye on it.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis — even one of our own — helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

BIIB – Could These 3 Potential Blockbusters Transform Biogen?

Biogen‘s (NASDAQ:BIIB) earnings report last week offered us a clear picture of why the biotech company is in need of a change. Its main multiple sclerosis (MS) business is on the decline as blockbuster Tecfidera loses ground to generic competition — and newer MS drug Vumerity is taking a while to generate significant revenue. Sales of other big drugs also are on the decline.

But there may be brighter days ahead for Biogen. CEO Michel Vounatsos says the company is in the process of becoming not just an MS company — but a full neuroscience company. Let’s take a look at three drugs with blockbuster potential and see if they can indeed transform this biotech giant.

Four researchers smile in a laboratory setting.

Image source: Getty Images.

1. Zuranolone for depression

Biogen recently reported positive data from a pivotal phase 3 trial investigating zuranolone for major depressive disorder (also known as clinical depression). The drug candidate showed statistically significant improvement in symptoms according to a commonly used rating scale. And patients who improved by Day 15 of treatment maintained 86% of that progress four weeks after the end of treatment.

Here’s where Biogen’s investigational drug stands out from current products: Today’s depression drugs generally require daily long-term use. But zuranolone is given daily for two weeks with the goal of producing rapid and sustained results. In another phase 3 study by partner Sage Therapeutics, 70% of trial participants who responded to initial treatment needed a maximum of one additional treatment in a 12-month period.

The U.S. Food and Drug Administration has given zuranolone Breakthrough Therapy Designation. This is meant to speed up the process for potentially game-changing products. Biogen and Sage are talking with the FDA about what comes next.

Depression will be the leading cause of disease burden by 2030, according to the World Health Organization. More than 264 million people worldwide suffer from the disorder. During last week’s earnings call, Vounatsos predicted zuranolone will be a multi-billion-dollar product.

2. TMS-007 for stroke

Biogen recently acquired TMS-007, an investigational treatment for acute ischemic stroke, from Japan’s TMS Co. The investigational drug is a thrombolytic agent — meaning it breaks up blood clots. But it has a clear advantage over today’s approved thrombolytic treatments. It’s demonstrated it can be used during a wider timeframe — without a high risk of symptomatic intracranial hemorrhage.

Patients in a phase 2a trial were dosed up to 12 hours after stroke. And none of them experienced intracranial hemorrhage. Rates of hemorrhage have been as high as 6% in studies of today’s thrombolytic therapies given in a nine-hour timeframe. If Biogen’s TMS-007 studies continue to go well, the company may have yet another game-changing product on the way.

And like zuranolone, this potential product addresses a vast market. The acute ischemic stroke market, at a compound annual growth rate of more than 4%, is expected to reach $11 billion by 2027, according to Verified Market Research.

3. Aduhelm for Alzheimer’s

Aduhelm may be one the most talked about new drugs right now. The FDA granted it accelerated approval last month. Some eagerly welcomed the treatment — the first to address the underlying cause of disease rather than just the symptoms. But Aduhelm has its share of dissenters. And many of them are doctors who aren’t ready to prescribe it for their patients.

The company also faces criticism over the treatment’s $56,000 annual price tag and an investigation into the regulatory approval process. Why all the problems? Biogen initially discontinued studies of the potential drug on evidence that it wouldn’t work. Then Biogen surprised investors when it reinstated the program. Many experts didn’t like that regulatory approval was based on a post-study analysis.

Biogen surely will face challenges with Aduhelm. But if it’s able to ease the minds of doctors and investors regarding the drug’s efficacy, the future could be bright. Some analyst predictions forecast peak sales as high as $15 billion — and that’s just in the U.S.

So, what are the chances of a Biogen transformation?

If Biogen is able to build neuroscience strengths with these three potential blockbusters, we may see a transformation. As sales of its main MS business decline, it’s clear the company must reach out into other areas.

We should keep our eyes on the Aduhelm story over the coming year. Biogen has said it doesn’t expect a huge contribution from the drug to earnings this year. But rollout and potential acceptance of the drug by doctors and health plans will offer us clues about its future. An update on zuranolone’s regulatory path and more data on TMS-007 will offer us clues too.

Biogen has climbed 34% year to date. And it’s trading about $100 lower than its record high of $440 back in 2015. At the same time, annual revenue and profit have started to decline.

BIIB Chart

BIIB data by YCharts

It will take some time to reverse that trend and get possibly these and other new products on the market to compensate for declines in older drugs. I think Biogen will transform. But the process may take quite a while. So, at current levels, I’m not in a rush to buy shares of this biotech giant.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis — even one of our own — helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

BIIB – Biogen to Present Data from ADUHELM and Alzheimer's Disease Portfolio at 2021 Alzheimer's Association International Conference

CAMBRIDGE, Mass., July 23, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced it will share multiple oral and poster presentations from its Alzheimer’s disease clinical development portfolio at the Alzheimer’s Association International Conference (AAIC), which will be held in Denver, Colorado and online July 26-30, 2021. The company’s contributions to AAIC will include several presentations highlighting data on ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution, which was recently granted accelerated approval by the U.S. Food and Drug Administration (FDA) as a treatment for Alzheimer’s disease, as well as its broader Alzheimer’s disease portfolio and research in the field.

ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Data presentations on ADUHELM will include presentations on multiple topics, including results of an analysis of the PRIME, EMERGE and ENGAGE studies on the correlation between reductions in biomarkers of Alzheimer’s disease and clinical decline after treatment with ADUHELM. The company’s contributions to the congress include four presentations on ADUHELM data and a total of 11 abstracts.

The company will also lead a late-breaking presentation on the design of the real-world observational Phase 4 study in Alzheimer’s disease, a prospective registry of ADUHELM, called International Collaboration for Real-World Evidence in Alzheimer’s Disease (ICARE AD-US). ICARE AD-US is focused on collecting real-world, long-term effectiveness and safety data on ADUHELM.

Biogen’s commitment to generate new data about ADUHELM includes three components: the ICARE AD study, the ongoing redosing study, EMBARK, for eligible patients previously enrolled in aducanumab trials, and the upcoming confirmatory, controlled Phase 4 trial that is part of the post-marketing requirement in connection with ADUHELM’s accelerated approval.

Posters and presentations will be available for 30 days on the AAIC conference website. Biogen will also post the aducanumab and BIIB080 posters and presentations on the investors section of its website at at the times indicated below.

Biogen Oral and Poster Presentations:

  • Oral presentation: ICARE AD-US: Design of a Prospective, Single-arm, Multicenter, Noninterventional Real-world Study of Aducanumab in United States: July 29, 10:00 am to 11:15 am ET (#57522). This presentation will be available on Biogen’s website concurrent with the presentation.
  • Poster presentation: Reduction in Biomarkers of Alzheimer’s Disease Pathophysiology Following Treatment with Aducanumab Were Associated with Slowing Clinical Decline – virtual poster #57499. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
  • Poster presentation: Subgroup Analyses of the Amyloid PET Substudies from EMERGE and ENGAGE, Phase 3 Clinical Trials Evaluating Aducanumab in Patients with Early Alzheimer’s Disease– virtual poster #57496. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
  • Poster presentation: Considerations for the Real-World Management of ARIA from the Aducanumab Phase 3 Studies EMERGE and ENGAGE – virtual poster #57498. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
  • Poster presentation: Item-level Analysis of Clinical Measures in Patients with Early Symptomatic Alzheimer’s Disease Following Treatment with High-Dose Aducanumab in the Phase 3 Study EMERGE – virtual poster #57619. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
  • Poster presentation: Ten-minute Cognitive Screening Tool for Mild Cognitive Impairment and Prediction of Pathological ß-amyloid – virtual poster #54618.
  • Oral presentation: Development of a Site Readiness Framework to Improve Health System Preparedness for Potential New Alzheimer’s Disease Therapies –July 29, 3:00 pm – 4:15 pm ET (#57672).
  • Oral presentation: Drivers and Barriers to Participation of Black and Hispanic Groups in Alzheimer’s Disease Clinical Trials: a Qualitative Study – Developing Topics 1 – July 29, 10:00 am – 11:15 am ET (#57652).
  • Poster presentation: Baseline Biomarker (Tau PET) Characteristics from TANGO: A Phase 2 Trial of Gosuranemab (BIIB092) in Early Alzheimer’s Disease – virtual poster #54952.
  • Poster presentation: Results of the First-in-Human, Randomized, Double-Blind, Placebo-Controlled Phase 1b Study of Lumbar Intrathecal Bolus Administrations of Antisense Oligonucleotide (ISIS 814907; BIIB080) Targeting Tau mRNA in Patients with Mild Alzheimer’s Disease– virtual poster #51871. This poster will be available on Biogen’s website on July 26 at 10:00 am ET.
  • Poster presentation: Clinical performance of the b-amyloid (1-42/1-40) ratio determined from automated Lumipulse G1200 cerebrospinal fluid Ab1-42 and Ab1-40 assays, assessed by concordance with PET imaging status– virtual poster #57725.

About ADUHELM™ (aducanumab-avwa) injection 100 mg/mL solution
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Aducanumab-avwa is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease. The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.

ADUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. ARIA is a common side effect that does not usually cause any symptoms but can be serious. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. ADUHELM can also cause serious allergic reactions. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA); headache; and fall. Patients should call their healthcare provider for medical advice about side effects.

Please see full Prescribing Information including Medication Guide.

About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing research programs in multiple sclerosis and neuroimmunology, Alzheimer’s disease and dementia, neuromuscular disorders, movement disorders, ophthalmology, neuropsychiatry, immunology, acute neurology and neuropathic pain.

We routinely post information that may be important to investors on our website at Follow us on social media – TwitterLinkedInFacebookYouTube.

Biogen Safe Harbor 
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: Biogen’s strategy and plans; potential of, and expectations for, Biogen’s commercial business, including ADUHELM; the potential clinical effects of ADUHELM; the potential benefits, safety and efficacy of ADUHELM; the treatment of Alzheimer’s disease; the anticipated benefits and potential of our collaboration arrangements with Eisai; the clinical development program, clinical trial(s) and data readouts and presentations for ADUHELM; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “potential,” “possible,” “prospect,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: risks relating to the launch of ADUHELM, including preparedness of healthcare providers to treat patients, the ability to obtain and maintain adequate reimbursement for ADUHELM and other unexpected difficulties or hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including ADUHELM; unexpected concerns that may arise from additional data or analysis obtained during clinical trials; actual timing and content of submissions to and decisions made by the regulatory authorities regarding ADUHELM; the occurrence of adverse safety events, restrictions on use or product liability claims; risks of unexpected costs or delays; the risk of other unexpected hurdles; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; third party collaboration risks; risks associated with current and potential future healthcare reforms; the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition; and any other risks and uncertainties that are described in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

BIIB – Biogen Defends Controversial Alzheimer's Drug as FDA Calls for Probe

Biogen’s new — and controversial — Alzheimer’s drug, Adhulem, made a modest $2 million in revenue in the first several weeks after its approval on June 7th, the company announced Thursday.

Biogen also surprised many by launching a defiant PR offensive: its head of research, Dr. Al Sandrock took the unusual step of releasing an open letter alongside the earnings report, accusing critics of the drug of “extensive misinformation and misunderstanding.”

Short on Data, Long on Drama

Aduhelm, the first FDA-approved Alzheimer’s drug in 20 years, has become a source of controversy since scientists and researchers have raised concerns about the research behind it.

Two late-stage clinical trials were shut down in 2019 when an independent panel concluded the drug wasn’t helping patients. Biogen later conducted its own analysis and found that high-dosage patients in just one trial showed a very small reduction in cognitive decline. While admitting there was no hard evidence on the drug’s merits, the U.S. Food and Drug Administration gave aduhelm the go-ahead anyway:

  • As a result, patients are now forking over $56,000 a year for the infusion treatment. The FDA used an “accelerated approval,” which allows the regulator to greenlight unproven treatments for serious diseases to make them available sooner for patients in need.
  • Meanwhile, three members of the FDA’s independent panel of outside experts — who refused to endorse aduhelm last fall on the basis that the data was insufficient — have resigned in protest since the agency approved the drug.

“This approval shouldn’t have happened,” Dr. Vissia Viglietta, Biogen’s former senior medical director who helped design the drug’s two clinical trials, told the New York Times. “It defeats everything I believe in scientifically and it lowers the rigor of regulatory bodies.”

Call In The Detectives: With the temperature being turned up on the agency, Acting FDA Commissioner Dr. Janet Woodcock, who was not involved in the approval decision, has asked the Office of the Inspector General to conduct an investigation into her agency over the matter. Biogen says it welcomes a probe.

Priced In: None of these developments are hurting Biogen’s bottom line. While its second-quarter sales slid to $2.8 billion (a 25% decline compared to last year), the company still beat expectations of $2.6 billion. And its shares rose 1.4% on Thursday.

BIIB – Biogen, under pressure, tells investors it ‘stands by' the FDA review process for its Alzheimer's drug

Biogen executives sought to assure investors that the science behind its newly approved Alzheimer’s disease drug is firm despite ongoing questions about whether the drug works, how it was approved, and what it costs. 

“I want to be clear that Biogen stands behind the integrity of the review process,” Biogen CEO Michael Vounatsos said Thursday, according to a FactSet transcript of the company’s second-quarter earnings call.

Shares of Biogen Inc.

gained 1.3% in trading on Thursday. Earlier in the day, the company disclosed that Aduhelm has generated $2 million in revenue since the June 7 approval. 

Biogen executives said Aduhelm’s launch has been slower than expected, and much of the earnings call featured company executives emphasizing the therapy’s clinical benefits, explaining the lengths the company went to ensuring the scientific integrity of the clinical trials, and promoting its focus on giving patients with Alzheimer’s a new treatment option. 

Aduhelm is the first new Alzheimer’s disease treatment in two decades.

“Biogen is struggling with negative commentary, acknowledging launch is slower than expected,” Bernstein’s Ronny Gal told investors on Thursday. “They spent a good amount of the call arguing against misinformation [and] negative media comments.”

The story behind Aduhelm is complicated. Biogen in 2019 scrapped development of the drug, saying the therapy didn’t work, before telling investors later that year that it planned to resurrect the drug.

More recently, members of the influential FDA advisory committee who had recommended against approving Aduhelm quit in response to the approval. Biogen itself requested a narrower label for the drug (which was granted by the FDA earlier this month). The acting FDA commissioner requested a federal investigation into her own agency’s handling of the approval. And several hospital systems including the Cleveland Clinic in Ohio and Mount Sinai Health System in New York have said they will not offer the drug to their patients. 

“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,” Dr. Alfred Sandrock, Biogen’s chief medical officer, said during the call. “We will cooperate fully with the review even as we prioritize the issues that affect patients.”

That means the company is moving forward with its commercial plans for Aduhelm. This includes working on reimbursement, designing the FDA-required confirmatory trial and a real-world observational study, and setting up care sites that can administer the drug. (Aduhelm is an infusion therapy that also requires brain magnetic resonance imaging scans in patients before being administered.)

Aduhelm is currently being reviewed by regulators in 10 countries, Biogen said. 

Biogen’s stock is up 31.9% for the year. Its shares hit a six-year high the day that Aduhelm was approved. The S&P 500

has gained 15.1% so far in 2021.

BIIB – Biogen Inc. (BIIB) Dips More Than Broader Markets: What You Should Know

In the latest trading session, Biogen Inc. (BIIB Free Report) closed at $324.62, marking a -1.08% move from the previous day. This change lagged the S&P 500’s 0.75% loss on the day.

Prior to today’s trading, shares of the company had lost 14.44% over the past month. This has lagged the Medical sector’s loss of 4.84% and the S&P 500’s gain of 2.74% in that time.

Wall Street will be looking for positivity from BIIB as it approaches its next earnings report date. This is expected to be July 22, 2021. The company is expected to report EPS of $4.59, down 55.26% from the prior-year quarter. Our most recent consensus estimate is calling for quarterly revenue of $2.61 billion, down 29.17% from the year-ago period.

Looking at the full year, our Zacks Consensus Estimates suggest analysts are expecting earnings of $18.59 per share and revenue of $10.61 billion. These totals would mark changes of -44.84% and -21.1%, respectively, from last year.

Investors might also notice recent changes to analyst estimates for BIIB. These recent revisions tend to reflect the evolving nature of short-term business trends. As a result, we can interpret positive estimate revisions as a good sign for the company’s business outlook.

Based on our research, we believe these estimate revisions are directly related to near-team stock moves. We developed the Zacks Rank to capitalize on this phenomenon. Our system takes these estimate changes into account and delivers a clear, actionable rating model.

The Zacks Rank system, which ranges from #1 (Strong Buy) to #5 (Strong Sell), has an impressive outside-audited track record of outperformance, with #1 stocks generating an average annual return of +25% since 1988. Over the past month, the Zacks Consensus EPS estimate remained stagnant. BIIB currently has a Zacks Rank of #3 (Hold).

Investors should also note BIIB’s current valuation metrics, including its Forward P/E ratio of 17.65. This valuation marks a discount compared to its industry’s average Forward P/E of 24.76.

Meanwhile, BIIB’s PEG ratio is currently 1.62. This popular metric is similar to the widely-known P/E ratio, with the difference being that the PEG ratio also takes into account the company’s expected earnings growth rate. The Medical – Biomedical and Genetics industry currently had an average PEG ratio of 1.3 as of yesterday’s close.

The Medical – Biomedical and Genetics industry is part of the Medical sector. This group has a Zacks Industry Rank of 204, putting it in the bottom 20% of all 250+ industries.

The Zacks Industry Rank includes is listed in order from best to worst in terms of the average Zacks Rank of the individual companies within each of these sectors. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1.

Make sure to utilize Zacks. Com to follow all of these stock-moving metrics, and more, in the coming trading sessions.

BIIB – Biogen stock falls after FDA calls for federal investigation into Alzheimer's drug approval

In this article

Biogen shares fell on Friday after the head of the Food and Drug Administration called for an investigation into the recent approval of the company’s Alzheimer’s drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock asked the Office of the Inspector General to investigate interactions between the U.S. agency and Biogen representatives prior to the drug’s approval on June 7.

“I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures,” Woodcock wrote in a letter sent Friday.

Shares of Biogen fell by more than 3% after the announcement.

Biogen’s stock surged last month after the FDA approved the biotech company’s drug, the first medication cleared by U.S. regulators to slow cognitive decline in people living with Alzheimer’s and the first new medicine for the disease in nearly two decades.

That decision marked a departure from the advice of the agency’s independent panel of outside experts, who unexpectedly declined to endorse the drug last fall, citing unconvincing data. At least three members of the panel have resigned in protest following the agency’s approval.

Federal regulators faced intense pressure from friends and family members of Alzheimer’s patients asking to fast-track the drug, scientifically known as aducanumab. STAT News and other media outlets reported FDA officials used a regulatory shortcut to gain approval in order to get the drug on the market sooner.

Biogen’s drug targets a “sticky” compound in the brain known as beta-amyloid, which scientists expect plays a role in the devastating disease. 

It’s rare for an FDA chief to call for an investigation into the agency’s own decisions. It’s the latest setback for the company and the drug, which has been controversial since it showed promise in 2016.

In March 2019, Biogen pulled development of the drug after an analysis from an independent group revealed it was unlikely to work. The company then shocked investors several months later by announcing it would seek regulatory approval for the medication after all.

When Biogen sought approval for the drug in late 2019, its scientists said a new analysis of a larger dataset showed aducanumab “reduced clinical decline in patients with early Alzheimer’s disease.”

Alzheimer’s experts and Wall Street analysts were immediately skeptical, with some wondering whether the clinical trial data was enough to prove the drug works and whether approval could make it harder for other companies to enroll patients in their own drug trials.

Some doctors have said they won’t prescribe aducanumab because of the mixed data package supporting the company’s application.

BIIB – The Upside for Biogen Is Absolutely Wild

Earlier this week, the Food and Drug Administration gave its stamp of approval to Biogen’s (NASDAQ:BIIB) new drug to treat Alzheimer’s. With a price point of $56,000 for the drug, and tens of millions of possible patients around the world, the market opportunity is staggering.

Corinne Cardina, bureau chief of Healthcare and Cannabis for the Motley Fool, and writer Taylor Carmichael run some Biogen numbers and try to make sense of it. This Fool Live segment was recorded on June 18.

Corinne Cardina: Let’s also talk about the price. What did they end up pricing it at?

Taylor Carmichael: $56,000 is what they’re talking about. I’m like, “Wow, why is it so much?” Because the market for Alzheimer’s is huge. There’s 6 million people in the United States with Alzheimer’s, and the number in the world is 44 million people in the world. So if you do that math, you try to figure out the market opportunity — if they get away with that $56,000 price point, which I don’t think they will — I mean, that’s a $336 billion drug. We call a drug a blockbuster if it’s 1 billion — so $336 billion just seems insane to me. Just my initial reaction is, “How do you think you’re going to get that much money?” I mean, that much money from Medicare?

Corinne Cardina: Yeah, that’s the total addressable market. When I talked to Dr. Brian Orelli about this and he basically said that he thinks they priced it at $56,000 because they know that this is not going to be prescribed to every single patient with Alzheimer’s. This is going to be kind of like a special-case drug, it will be for a certain niche of Alzheimer’s patients — you don’t want to be so far along Alzheimer’s. It’ll be for a very small group of the 6 million people in the U.S., a small group of the 44 million people worldwide.

Taylor Carmichael: That makes more sense. 

Corinne Cardina: Those are some mind-boggling numbers, [laughs] but I don’t think they’ll get that close.

Taylor Carmichael: I don’t, either. There’s so many doctors who are against this drug. Let me read what Public Citizen wrote to the Biden administration about this, about the FDA approval: “Shows a sudden disregard for science. It viscerated the agency standards for approving new drugs and ranks as one of the most irresponsible and egregious decisions in the history of the agency.” To have your doctors who were reviewing the data all resign en masse after you overlook what they said — I don’t know, this is a very interesting situation. I mean, Biogen’s stock has done really well, obviously, because this was a big surprise, the FDA approval.

Corinne Cardina: It doesn’t give you a lot of faith [laughs] in the drug, but on the flip side of this. Obviously, on one side are the doctors who want to see very clear efficacy and safety data. But on the other side, you have the Alzheimer’s patients and their families and loved ones, and they don’t have good treatments for this awful devastating disease. They’ve been advocating for more options. If you are desperate for your loved one or for yourselves to delay the progression of this devastating disease, I could see wanting to try everything.

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