Latest news with #BiogenInc
Associated Press
19 hours ago
- Health
- Associated Press
New Data for Nusinersen Underscore Biogen's Commitment to Advancing Clinical Research to Improve Outcomes in SMA
CAMBRIDGE, Mass., June 27, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced new data that reinforce the clinical impact of nusinersen across a broad spectrum of individuals affected by spinal muscular atrophy (SMA). These latest findings from Part C of the DEVOTE trial evaluating a higher dose regimen of nusinersen and the NURTURE trial which evaluated the approved 12 mg regimen (SPINRAZA®) in clinically presymptomatic SMA were presented at the SMA Research & Clinical Care Meeting hosted by Cure SMA in Anaheim, Calif. Biogen's applications for the higher dose regimen of nusinersen are currently under review in the U.S., Europe, Japan and other global markets. The higher dose regimen of nusinersen comprises a more rapid loading regimen – two 50 mg doses 14 days apart – and a higher maintenance regimen – 28 mg every four months. 'As the SMA treatment landscape continues to evolve, we remain steadfast in our commitment to address the unmet needs of the community. The findings from Part C of the DEVOTE study further strengthen the growing body of evidence supporting the potential benefits of the higher dose regimen of nusinersen,' said Stephanie Fradette, Pharm.D., Head of the Neuromuscular Development Unit at Biogen. Improvements Observed With Higher Dose Regimen of Nusinersen in Previously Treated Patient Population Detailed results from Part C of the DEVOTE study highlight the potential clinical benefits of an investigational higher dose of nusinersen in a broad range of individuals (n=38) who had been previously treated with nusinersen at the approved 12 mg dose for approximately four years (median: 3.9 years). Participants were 4 to 65 years of age and half (n=19) were ambulatory. Participants in Part C received one loading dose (50 mg) and two maintenance doses (28 mg each) of open-label higher dose nusinersen during the study period. Most participants experienced improvements on the Hammersmith Functional Motor Scale – Expanded (HFMSE), Revised Upper Limb Module (RULM), and/or Clinical Global Impression of Change (CGI-C; assessed by investigator or caregiver) after transitioning to the higher dose regimen. These improvements were observed across phenotypes, functional status and age. For example, non-ambulatory participants improved by +2.5 (95% CI: 0.49, 4.56) on average on the HFMSE, and ambulatory participants improved by +1.1 (95% CI: -0.68, 2.89). 'These emerging data indicate that additional gains in function might be possible even in those with established disease who have been on therapy for years,' said Richard Finkel, M.D., director, Center for Experimental Neurotherapeutics (CENT) at St. Jude Children's Research Hospital. 'This effort to optimize the dosing of SPINRAZA is very exciting for the field and could fundamentally change how we treat our patients.' The safety profile of the higher dose regimen of nusinersen is broadly consistent with the known safety profile of 12 mg SPINRAZA. In the DEVOTE study overall, reported adverse events (AEs) included pneumonia, respiratory failure, pyrexia, COVID, upper respiratory tract infection, procedural pain and procedural headache. In Part C (n=40), AEs were reported in 37/40 participants, the majority of which were mild or moderate in severity. Serious AEs were reported by six participants (15%), none of which were considered by the investigator to be related to study treatment or administration. Final NURTURE Data Redefine Expectations for Early Treatment Final data from the eight-year, open-label NURTURE study highlight the impact of early intervention with 12 mg SPINRAZA in clinically presymptomatic infants with SMA. At the study conclusion, all children who participated in NURTURE (n=25) were alive and experienced continued clinical benefits over the course of the study. No participants required permanent ventilation, and the majority (20 of 25 participants) went without any ventilatory support throughout the study. Ninety-two percent of participants achieved the ability to walk independently, many within normal developmental timeframes. Participants with elevated levels of neurofilament light chain (NfL) at baseline experienced rapid and sustained reductions in NfL after initiation of nusinersen, reinforcing the potential utility of NfL as an objective biomarker of disease activity and treatment response in SMA. Nusinersen was generally well tolerated with no new safety concerns identified with eight years of follow-up. All participants had at least one AE, the majority of which were mild to moderate in severity; no AEs led to treatment discontinuation or study withdrawal. About SPINRAZA SPINRAZA (nusinersen) 12 mg/5 mL injection is approved in more than 71 countries to treat infants, children and adults with spinal muscular atrophy (SMA). As a foundation of care in SMA, more than 14,000 individuals have been treated with SPINRAZA worldwide.1 The currently approved 12 mg regimen for SPINRAZA is comprised of four loading doses administered over approximately 60 days, followed by maintenance dosing every four months thereafter. SPINRAZA is an antisense oligonucleotide (ASO) that targets the underlying cause of motor neuron loss by continuously increasing the amount of full-length survival motor neuron (SMN) protein produced in the body.2 It is administered directly into the central nervous system, where motor neurons reside, to deliver treatment where the disease starts.2 SPINRAZA has shown sustained efficacy across ages and SMA types with a well-established safety profile based on data in patients treated up to 10 years,3,4 combined with unsurpassed real-world experience. The nusinersen clinical development program encompasses more than 10 clinical studies, which have included more than 460 individuals across a broad spectrum of patient populations, including two randomized controlled studies (ENDEAR and CHERISH). The most common adverse events observed in clinical studies were respiratory infection, fever, constipation, headache, vomiting and back pain. Laboratory tests can monitor for renal toxicity and coagulation abnormalities, including acute severe low platelet counts, which have been observed after administration of some ASOs. Biogen licensed the global rights to develop, manufacture and commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq: IONS). Please click here for Important Safety Information and full Prescribing Information for SPINRAZA in the U.S., or visit your respective country's product website. About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at Follow us on social media - Facebook, LinkedIn, X, YouTube. Biogen Safe Harbor This news release contains forward-looking statements, including related to the potential clinical effects of a higher dose regimen of nusinersen; the potential benefits, safety and efficacy of higher dose regimen of nusinersen; the clinical development program for higher dose regimen of nusinersen; the identification and treatment of SMA; our research and development program for the treatment of SMA; the potential of our commercial business and pipeline programs, including SPINRAZA; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'intend,' 'may,' 'plan,' 'potential,' 'possible,' '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 our forward-looking statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, uncertainty of success in the development and potential commercialization of higher dose regimen of nusinersen; the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected; unexpected concerns may arise from additional data, analysis or results obtained during our clinical trials; 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 SPINRAZA; the occurrence of adverse safety events; the risks of unexpected hurdles, costs or delays; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our most recent annual or quarterly report and in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. We do not undertake any obligation to publicly update any forward-looking statements. References:
Yahoo
28-05-2025
- Business
- Yahoo
Biogen Inc. (BIIB) Taps RNAi Therapy in City Therapeutics Deal
Biogen Inc. (NASDAQ:BIIB)'s recent partnership with City Therapeutics, Inc. to develop RNAi therapies for central nervous system diseases has fueled a 6% rise in its share price over the past month, reflecting renewed investor optimism. This move comes amid a broader rally in the tech sector driven by favorable policy shifts and positive market sentiment, as major indices have also trended upward. A scientist studying a petri dish with magnifying glass in a laboratory setting. The collaboration underscores Biogen Inc. (NASDAQ:BIIB)'s strategic pivot toward innovative treatments, expanding its pipeline beyond established Alzheimer's therapies like LEQEMBI. Analysts suggest this could strengthen BIIB's long-term growth prospects and help offset challenges such as declining multiple sclerosis revenues and mounting competition from generics and biosimilars. Despite the recent uptick, Biogen Inc. (NASDAQ:BIIB)'s three-year total shareholder return remains down 37.09%, significantly underperforming the broader US biotech industry, which gained 12.9% over the past year. The company's current share price still trades at a 36.67% discount to the analyst consensus target of $171.95, highlighting persistent investor caution regarding future earnings and revenue growth. While the RNAi collaboration may gradually shift market perceptions, BIIB faces ongoing pressure to deliver on its innovation-driven strategy and regain industry momentum. While we acknowledge the potential of BIIB to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than BIIB and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
01-04-2025
- Business
- Yahoo
Biogen (NASDAQ:BIIB) sheds US$697m, company earnings and investor returns have been trending downwards for past five years
Generally speaking long term investing is the way to go. But that doesn't mean long term investors can avoid big losses. For example the Biogen Inc. (NASDAQ:BIIB) share price dropped 56% over five years. That's an unpleasant experience for long term holders. And it's not just long term holders hurting, because the stock is down 36% in the last year. Furthermore, it's down 11% in about a quarter. That's not much fun for holders. However, one could argue that the price has been influenced by the general market, which is down 5.4% in the same timeframe. Since Biogen has shed US$697m from its value in the past 7 days, let's see if the longer term decline has been driven by the business' economics. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. In his essay The Superinvestors of Graham-and-Doddsville Warren Buffett described how share prices do not always rationally reflect the value of a business. One imperfect but simple way to consider how the market perception of a company has shifted is to compare the change in the earnings per share (EPS) with the share price movement. Looking back five years, both Biogen's share price and EPS declined; the latter at a rate of 19% per year. The share price decline of 15% per year isn't as bad as the EPS decline. So the market may previously have expected a drop, or else it expects the situation will improve. The company's earnings per share (over time) is depicted in the image below (click to see the exact numbers). We're pleased to report that the CEO is remunerated more modestly than most CEOs at similarly capitalized companies. It's always worth keeping an eye on CEO pay, but a more important question is whether the company will grow earnings throughout the years. Before buying or selling a stock, we always recommend a close examination of historic growth trends, available here.. While the broader market gained around 7.7% in the last year, Biogen shareholders lost 36%. Even the share prices of good stocks drop sometimes, but we want to see improvements in the fundamental metrics of a business, before getting too interested. Unfortunately, last year's performance may indicate unresolved challenges, given that it was worse than the annualised loss of 9% over the last half decade. Generally speaking long term share price weakness can be a bad sign, though contrarian investors might want to research the stock in hope of a turnaround. While it is well worth considering the different impacts that market conditions can have on the share price, there are other factors that are even more important. Case in point: We've spotted 1 warning sign for Biogen you should be aware of. Of course Biogen may not be the best stock to buy. So you may wish to see this free collection of growth stocks. Please note, the market returns quoted in this article reflect the market weighted average returns of stocks that currently trade on American exchanges. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
Yahoo
23-02-2025
- Business
- Yahoo
Biogen Inc. (BIIB): Among the Cheap Pharmaceutical Stocks to Buy According to Analysts
We recently compiled a list of the . In this article, we are going to take a look at where Biogen Inc. (NASDAQ:BIIB) stands against the other pharmaceutical stocks. Almost no other industry goes as far as the phrase "defensive" as the healthcare sector, which encompasses a wide range of companies that provide patient care, research and development of new medicines, and design, manufacture, and sell diagnostic instruments and tests. Patient care has evolved due to advancements in therapeutic techniques, drugs, and medical technology. Pharmaceutical companies in particular have received much attention as the demand for speedy results has increased. Grand View Research predicted that the value of pharmaceutical manufacturing worldwide was $516.48 billion in 2022. The sector is anticipated to increase at a compound annual growth rate (CAGR) of 7.63% between 2023 and 2030. The biopharma industry now has the most extensive and varied clinical pipeline to date, due to decades of groundbreaking research. In 2012, there were 3,200 distinct medications under development; by 2022, that number had nearly doubled to 6,100. The average cost of producing a single treatment is over $1 billion, while just 14% of medications in clinical trials reach FDA clearance, according to MIT research. This could be a game-changer for AI. For instance, generative AI helps identify illness patterns in large data sets to determine the optimal medicine combinations while enabling researchers to investigate far more possible compounds than they could with conventional techniques. Additionally, according to PwC, AI-driven analytics and automation could cut operational costs by more than 30% and process timeframes by 60–70%. In a similar vein, the market has grown significantly due to consumer interest in weight-loss medications like Ozempic and Wegovy. According to a recent study in the scientific journal Addiction, GLP-1 medications may reduce the prevalence of alcohol and opioid addiction by as much as 50%. Additionally, these medications are being evaluated for Alzheimer's disease and other disorders that are frequently associated with obesity. The development of GLP-1s is becoming crucial for pharmaceutical businesses that want to be leaders in fields like cardiovascular and renal health. Competition with the leading companies in the anti-obesity business, which is expected to grow to $130 billion by 2030, is no longer the main emphasis. The possibility for additional participants to enter the field is growing along with the possible applications of GLP-1s. For example, the Swiss business Roche entered the weight-loss drug sweepstakes in 2023 when it paid up to $3.1 billion to acquire California-based Carmot Therapeutics. The corporation wants to "fast-track" its anti-obesity medicines to regain faith in its pipeline and take a share of the weight-loss market. The pharmaceutical sector may appear to be flourishing at first glance. However, it has its own set of difficulties, just like every other industry. Compared to 2021, funding for biotech and pharmaceuticals fell by a sharp 48.6% last year. In 2022, the IPO market also saw a significant decline, with profits falling as a result of market volatility and instability. Many general investors were apprehensive of the spike in drug-developer initial public offerings (IPOs) in 2020 and 2021, which garnered about $46.5 billion, more than the total from the preceding eight years combined. Future initial public offerings (IPOs) are being closely watched due to the high-risk, high-reward nature of the biotech sector as well as macroeconomic and geopolitical issues that impact larger markets. However, as of September 3, 2024, drug developers had raised $2 billion through initial public offerings (IPOs) this year, a 24% increase over the same period in 2023. However, according to BNN Bloomberg, over two-thirds of these funds were raised in the first two months as a result of a spike in new listings. However, pharma companies' portion of U.S. IPO profits has decreased from 17% in February to 6.5%, with less than $800 million raised in the next six months. Tim Hunt, CEO of the Alliance for Regenerative Medicine (ARM), emphasized increased funding in cell and gene therapies in 2024 in his opening remarks at the October 7 conference. According to him, thirteen of the fifteen biggest pharmaceutical companies in the world by market capitalization now have an "active presence" in this area. Major pharmaceutical corporations are increasingly turning to cell and gene therapies to fill possible revenue shortages as many product patents are about to expire. Despite this optimism, there has been a reduction in related patent filings, and the number of cell and gene therapy deals in the pharmaceutical industry fell by 38% in Q2 2024 compared to the same time in 2023. Nevertheless, the sector is appealing and should not be disregarded by possible investors. Given this, we will take a look at some of the best cheap pharmaceutical stocks according to analysts. Our methodology involved selecting stocks with a market capitalization exceeding $3 billion, a P/E ratio below 40, and a price target upside of more than 10%. We then ranked these stocks based on their upside potential, as of February 17. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 363.5% since May 2014, beating its benchmark by 208 percentage points (). A patient receiving physical therapy for a neurological disease. Price Target Upside: 60.66% Biogen Inc. (NASDAQ:BIIB) is a leading biotechnology company focused on developing and commercializing therapies for neurological and neurodegenerative diseases, including multiple sclerosis, Alzheimer's disease, and spinal muscular atrophy. Biogen Inc. (NASDAQ:BIIB)'s Q4 2024 earnings call on February 12, 2025, highlighted key financial trends. While total revenue declined by $160 million, the core pharmaceutical business grew for the first time in four years, driven by four new product launches: Leqembi (Alzheimer's), Skyclarys (Friedreich's ataxia), Zurzuvae (postpartum depression), and Qalsody (ALS). These products offset declining MS revenue, with Leqembi seeing strong growth in Asia, Skyclarys doubling patient numbers, and Zurzuvae exceeding expectations. Biogen Inc. (NASDAQ:BIIB) also streamlined operations to cut costs while reinvesting in growth, leveraging strong cash flow for future opportunities. As of Q3 2024, 49 hedge funds held shares in Biogen Inc. (NASDAQ:BIIB), as tracked by the Insider Monkey database. The largest stakeholder was with stakes worth $2.5 billion. Overall BIIB ranks 2nd on our list of the cheap pharmaceutical stocks to buy according to analysts. While we acknowledge the potential of BIIB as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than BIIB but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and Complete List of 59 AI Companies Under $2 Billion in Market Cap. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Bloomberg
12-02-2025
- Business
- Bloomberg
Biogen Beats Estimates as Alzheimer Drug Leqembi Lifts Quarterly Sales
Biogen Inc. reported better-than-expected quarterly earnings, driven by continued growth in sales of its Alzheimer's drug Leqembi. Adjusted fourth-quarter earnings were $3.44 a share, the Cambridge, Massachusetts-based company said Wednesday in a statement. That's up 17% from a year earlier and exceeded analysts' estimates.
