Últimas noticias sobre Biogen (NASDAQ:BIIB) Bolsa

Biogen

Biogen and Idec merged in 2003, combining forces to market Biogen's multiple sclerosis drug Avonex and Idec's cancer drug Rituxan. Today, Rituxan and next-generation antibody Gazyva (oncology) and Ocrevus (multiple sclerosis) are marketed via a collaboration with Roche. Biogen markets several multiple sclerosis drugs including Plegridy, Tysabri, Tecfidera, and Vumerity. Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys (Friedreich's Ataxia, Reata), Zurzuvae (postpartum depression, Sage), and Qalsody (ALS, Ionis). Biogen has several drug candidates in phase 3 trials in neurology, immunology, and rare diseases.

Biogen Inc

Needham analyst Ami Fadia reiterates Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) from Hold to Hold.

News

Reiteration

Analyst Ratings

BIIB

Needham Reiterates Hold on Biogento Hold

In the European Union (EU), lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein E ε4 (ApoE ε4&#x2A;) non-carriers or heterozygotes with confirmed amyloid pathology
Lecanemab is the first therapy that targets an underlying cause of&nbsp;the disease to be authorized in the EU for eligible people with early AD

ESAIY

Reported Earlier, European Commission Approves Eisai And Biogen's Leqembi As First Disease-Modifying Therapy For Early Alzheimer's

Morgan Stanley analyst Matthew Harrison maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Equal-Weight and lowers the price target from $157 to $152.

Price Target

Morgan Stanley Maintains Equal-Weight on Biogen, Lowers Price Target to $152

Several exemptions exist among President Donald Trump&#8216;s <a href="https://www.benzinga.com/markets/25/04/44621408/market-access-has-a-price-trump-unveils-list-of-tariffs-countries-targeted" target="_blank" rel="noopener">broad tariffs</a>, which were announced on Wednesday. 
The biopharma industry has historically been shielded from tariffs, including during Trump&#8217;s first term. Given its significant manufacturing presence in Europe, investors had feared global tariffs could disrupt the sector.
Morningstar <a href="https://www.morningstar.com/stocks/biopharma-industry-exempt-global-10-tariff-we-still-see-margin-tax-rate-risks" target="_blank" rel="noopener">reports</a> that with the U.S. importing approximately $200 billion in pharmaceuticals in 2024, a 10% tariff could have cost the industry $20 billion, with some of the largest firms facing annual tariffs of up to $1 billion.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44642463/french-president-macron-suggests-suspension-of-eu-investments-in-us-amid-tariff-turmoil" rel="noreferrer noopener">French President Macron Suggests Suspension Of EU Investments In US Amid Tariff Turmoil, Vows &#8216;More Powerful&#8217; Response</a>
Goldman Sachs expects continued volatility in the biotechnology sector (XBI and S&amp;P 500 are down about 14% and 7% year-to-date, respectively), driven by broader economic <a target="_blank" href="https://www.benzinga.com/news/global/25/04/44631606/trumps-tariff-exemptions-include-semiconductors-pharmaceuticals-oil-and-more" rel="noreferrer noopener">uncertainty and unclear healthcare policy</a>.
Analyst Salveen Richter has analyzed geographic exposure and tax rates for individual companies and sees Vertex Pharmaceuticals Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRTX#NASDAQ">VRTX</a>) and Alnylam Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ALNY#NASDAQ">ALNY</a>) in the strongest position, followed by Gilead Sciences Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Amgen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) and Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>).
Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) raises some concerns due to its significant presence in Ireland. If tariffs are applied, they would likely increase the cost of goods sold since companies often import ingredients or finished products into the U.S.
Analyst Richter adds that <a target="_blank" href="https://www.benzinga.com/quote/AMGN" rel="noreferrer noopener">Amgen</a>, <a target="_blank" href="https://www.benzinga.com/quote/ALNY" rel="noreferrer noopener">Alnylam</a>, <a target="_blank" href="https://www.benzinga.com/quote/BIIB" rel="noreferrer noopener">Biogen</a>, and <a target="_blank" href="https://www.benzinga.com/quote/REGN" rel="noreferrer noopener">Regeneron</a> are the least exposed to Medicaid risk.
Goldman Sachs said Friday that it&#8217;s been hard to measure the exact impact of potential tariffs on U.S. biopharma due to limited public data on where drugs are made.
Their analysis shows limited manufacturing exposure to Canada, Mexico and China. Pharmaceuticals from Canada and Mexico are also likely exempt under the USMCA trade deal. However, some companies do rely heavily on manufacturing in the EU.
If tariffs are placed on drugs made outside the U.S. and kept in place, they could raise manufacturing costs. Companies often import ingredients or finished products before selling them in the U.S. Some manufacturers are reportedly speeding up shipments from Europe out of concern that tariffs may apply to <a href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" target="_blank" rel="noopener">those products,</a><a href="https://www.benzinga.com/general/biotech/25/03/44440233/pharmaceutical-firms-say-uk-investment-is-unlikely-unless-payment-levy-is-adressed" target="_blank" rel="noreferrer noopener"> too</a>.
Goldman Sachs is also watching for exceptions or phased rollouts, pointing to a similar eight-year grace period in the Biosecure Act.
Still, the analyst writes that biopharma companies are generally resilient due to their high profit margins and globally spread operations.
Companies that produce small-molecule drugs might handle a U.S. manufacturing shift better than those making biologics since small molecules require less complex production.
Senator Ron Wyden has raised concerns about Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) using offshore setups to reduce U.S. taxes.
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Photo: Shutterstock

Biotech

Government

Large Cap

Health Care

General

ALNY

AMGN

GILD

REGN

VRTX

Vertex, Alnylam Best Positioned As Biopharma Braces For Tariff Impact, Goldman Sachs Flags Regeneron, Biogen Risks

During the last three months, 14 analysts shared their evaluations of Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), revealing diverse outlooks from bullish to bearish.
The table below offers a condensed view of their recent ratings, showcasing the changing sentiments over the past 30 days and comparing them to the preceding months.
<table>
<thead>
<tr>
<th></th>
<th align="right">Bullish</th>
<th align="right">Somewhat Bullish</th>
<th align="right">Indifferent</th>
<th align="right">Somewhat Bearish</th>
<th align="right">Bearish</th>
</tr>
</thead>
<tbody>
<tr>
<td>Total Ratings</td>
<td align="right">5</td>
<td align="right">2</td>
<td align="right">7</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>Last 30D</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>1M Ago</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M Ago</td>
<td align="right">4</td>
<td align="right">2</td>
<td align="right">5</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>3M Ago</td>
<td align="right">1</td>
<td align="right">0</td>
<td align="right">2</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
Analysts have set 12-month price targets for Biogen, revealing an average target of $190.79, a high estimate of $265.00, and a low estimate of $135.00. A 12.91% drop is evident in the current average compared to the previous average price target of $219.07. 
<img src="https://www.benzinga.com/files/images/story/2025/1743789614_0.png" alt="price target chart" />
<h2>Deciphering Analyst Ratings: An In-Depth Analysis</h2>
In examining recent analyst actions, we gain insights into how financial experts perceive Biogen. The following summary outlines key analysts, their recent evaluations, and adjustments to ratings and price targets.
<table>
<thead>
<tr>
<th>Analyst</th>
<th>Analyst Firm</th>
<th>Action Taken</th>
<th>Rating</th>
<th>Current Price Target</th>
<th>Prior Price Target</th>
</tr>
</thead>
<tbody>
<tr>
<td>Christopher Raymond</td>
<td>Piper Sandler</td>
<td>Lowers</td>
<td>Neutral</td>
<td>$135.00</td>
<td>$138.00</td>
</tr>
<tr>
<td>George Farmer</td>
<td>Scotiabank</td>
<td>Lowers</td>
<td>Sector Outperform</td>
<td>$224.00</td>
<td>$244.00</td>
</tr>
<tr>
<td>Evan Seigerman</td>
<td>BMO Capital</td>
<td>Lowers</td>
<td>Market Perform</td>
<td>$139.00</td>
<td>$156.00</td>
</tr>
<tr>
<td>Matthew Harrison</td>
<td>Morgan Stanley</td>
<td>Lowers</td>
<td>Equal-Weight</td>
<td>$157.00</td>
<td>$192.00</td>
</tr>
<tr>
<td>Salveen Richter</td>
<td>Goldman Sachs</td>
<td>Lowers</td>
<td>Buy</td>
<td>$245.00</td>
<td>$281.00</td>
</tr>
<tr>
<td>Brian Abrahams</td>
<td>RBC Capital</td>
<td>Lowers</td>
<td>Outperform</td>
<td>$225.00</td>
<td>$231.00</td>
</tr>
<tr>
<td>Geoff Meacham</td>
<td>Citigroup</td>
<td>Lowers</td>
<td>Neutral</td>
<td>$145.00</td>
<td>$160.00</td>
</tr>
<tr>
<td>Mohit Bansal</td>
<td>Wells Fargo</td>
<td>Lowers</td>
<td>Equal-Weight</td>
<td>$140.00</td>
<td>$165.00</td>
</tr>
<tr>
<td>Andrew Fein</td>
<td>HC Wainwright &amp; Co.</td>
<td>Lowers</td>
<td>Buy</td>
<td>$241.00</td>
<td>$300.00</td>
</tr>
<tr>
<td>Srikripa Devarakonda</td>
<td>Truist Securities</td>
<td>Lowers</td>
<td>Buy</td>
<td>$210.00</td>
<td>$220.00</td>
</tr>
<tr>
<td>Sumant Kulkarni</td>
<td>Canaccord Genuity</td>
<td>Lowers</td>
<td>Buy</td>
<td>$265.00</td>
<td>$298.00</td>
</tr>
<tr>
<td>Geoff Meacham</td>
<td>Citigroup</td>
<td>Lowers</td>
<td>Neutral</td>
<td>$160.00</td>
<td>$190.00</td>
</tr>
<tr>
<td>Mohit Bansal</td>
<td>Wells Fargo</td>
<td>Lowers</td>
<td>Equal-Weight</td>
<td>$165.00</td>
<td>$190.00</td>
</tr>
<tr>
<td>Srikripa Devarakonda</td>
<td>Truist Securities</td>
<td>Lowers</td>
<td>Buy</td>
<td>$220.00</td>
<td>$302.00</td>
</tr>
</tbody>
</table>
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: In response to dynamic market conditions and company performance, analysts update their recommendations. Whether they 'Maintain', 'Raise', or 'Lower' their stance, it signifies their reaction to recent developments related to Biogen. This insight gives a snapshot of analysts' perspectives on the current state of the company.</li>
<li>Rating: Delving into assessments, analysts assign qualitative values, from 'Outperform' to 'Underperform'. These ratings communicate expectations for the relative performance of Biogen compared to the broader market.</li>
<li>Price Targets: Understanding forecasts, analysts offer estimates for Biogen's future value. Examining the current and prior targets provides insight into analysts' changing expectations.</li>
</ul>
Understanding these analyst evaluations alongside key financial indicators can offer valuable insights into Biogen's market standing. Stay informed and make well-considered decisions with our Ratings Table.
<a href="https://www.benzinga.com/quote/BIIB/analyst-ratings?adType=benzinga-insights&amp;ad=analyst-ratings&amp;campaign=wallstreetadvantage">Stay up to date on Biogen analyst ratings.</a>
<h2>About Biogen</h2>
Biogen and Idec merged in 2003, combining forces to market Biogen's multiple sclerosis drug Avonex and Idec's cancer drug Rituxan. Today, Rituxan and next-generation antibody Gazyva (oncology) and Ocrevus (multiple sclerosis) are marketed via a collaboration with Roche. Biogen markets several multiple sclerosis drugs including Plegridy, Tysabri, Tecfidera, and Vumerity. Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys (Friedreich's Ataxia, Reata), Zurzuvae (postpartum depression, Sage), and Qalsody (ALS, Ionis). Biogen has several drug candidates in phase 3 trials in neurology, immunology, and rare diseases.
<h3>Financial Insights: Biogen</h3>
Market Capitalization Analysis: The company exhibits a lower market capitalization profile, positioning itself below industry averages. This suggests a smaller scale relative to peers.
Revenue Growth: Biogen's revenue growth over a period of 3 months has been noteworthy. As of 31 December, 2024, the company achieved a revenue growth rate of approximately 2.87%. This indicates a substantial increase in the company's top-line earnings. As compared to competitors, the company encountered difficulties, with a growth rate lower than the average among peers in the Health Care sector.
Net Margin: The company's net margin is below industry benchmarks, signaling potential difficulties in achieving strong profitability. With a net margin of 10.86%, the company may need to address challenges in effective cost control.
Return on Equity (ROE): Biogen's ROE stands out, surpassing industry averages. With an impressive ROE of 1.61%, the company demonstrates effective use of equity capital and strong financial performance.
Return on Assets (ROA): Biogen's ROA surpasses industry standards, highlighting the company's exceptional financial performance. With an impressive 0.95% ROA, the company effectively utilizes its assets for optimal returns.
Debt Management: Biogen's debt-to-equity ratio is below the industry average. With a ratio of 0.4, the company relies less on debt financing, maintaining a healthier balance between debt and equity, which can be viewed positively by investors.
<h2>What Are Analyst Ratings?</h2>
Analyst ratings serve as essential indicators of stock performance, provided by experts in banking and financial systems. These specialists diligently analyze company financial statements, participate in conference calls, and engage with insiders to generate quarterly ratings for individual stocks.
Analysts may enhance their evaluations by incorporating forecasts for metrics like growth estimates, earnings, and revenue, delivering additional guidance to investors. It is vital to acknowledge that, although experts in stocks and sectors, analysts are human and express their opinions when providing insights.
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

What 14 Analyst Ratings Have To Say About Biogen

Argus Research analyst Jasper Hellweg downgrades Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) from Buy to Hold.

Downgrades

Argus Research Downgrades Biogen to Hold

Biogen Says FDA Granted Fast Track Designation To BIIB080, An Investigational Antisense Oligonucleotide Therapy Targeting Tau, For Treatment Of Alzheimer's Disease

Organon Acquires Regulatory And Commercial Rights In The US For TOFIDENCE From Biogen

European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an opinion that does not recommend Eli Lilly and Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) donanemab be granted marketing authorization for the treatment of early symptomatic Alzheimer's disease. Lilly will seek <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">re-examination by CHMP</a>.
Kisunla (donanemab) is <a target="_blank" href="https://investor.lilly.com/news-releases/news-release-details/lillys-statement-about-chmp-opinion-issued-donanemab" rel="noreferrer noopener">used</a> to treat adults with early symptomatic Alzheimer's disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44175948/alzheimers-drugs-from-eli-lilly-and-biogen-still-deemed-too-costly-for-nhs-funding" rel="noreferrer noopener">Alzheimer's Drugs From Eli Lilly And Biogen Still Deemed Too Costly For NHS Funding</a>
In October 2024, Eli Lilly released results from the TRAILBLAZER-ALZ 6 Phase&nbsp;3b&nbsp;study to investigate different dosing regimens of donanemab and their effect on amyloid-related imaging abnormalities with edema/effusion (ARIA-E) in adults with early&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41608511/eli-lilly-says-new-data-can-potentially-provide-path-to-improved-donanemab-profile-by-lower-risk-" rel="noreferrer noopener">symptomatic Alzheimer's disease</a>.
The data showed a reduction in amyloid-related imaging abnormalities with edema/effusion (ARIA-E) at the 24-week primary endpoint for people receiving a slightly modified titration of donanemab in adults with early symptomatic Alzheimer's disease.
On Thursday, Eli Lilly expanded its LillyDirect digital healthcare platform to offer connections to independent in-person and telehealth options for <a target="_blank" href="https://www.benzinga.com/pressreleases/25/03/n44513552/lillydirect-platform-expands-to-facilitate-access-to-alzheimers-disease-care" rel="noreferrer noopener">Alzheimer's patients in the U.S.</a>
William Blair views "the CHMP's negative opinion on Kisunla as unsurprising, given the initial negative opinion for Leqembi, but nonetheless view it as an incremental win for Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) and Eisai."
Analyst Myles Minter writes that given that the CHMP changed its stance to support Biogen's Leqembi after a formal review, it's highly likely that Lilly will challenge Friday's decision. Historically, appeals in European marketing application authorization (MAA) filings have led to a reversal about 25% of the time.
William Blair estimates that Leqembi's sales in the EU could reach $1.3 billion by 2031. Analyst Minter sees Leqembi as a growth driver for Biogen, especially if advancements like a potential subcutaneous version get approved. However, sales are growing more slowly than expected.
The analyst reiterates Biogen's Outperform rating but acknowledges that without substantial M&amp;A activity, this is a show-me story about returning to growth with the current portfolio.
Price Action: BIIB stock is down 1% at $138.92, and LLY stock is down 0.26% at $819.55&nbsp;at the last check Friday.
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</ul>
Image via Shutterstock

Analyst Color

European Drug Regulator Gives Thumbs Down To Eli Lilly's Alzheimer's Drug, Analyst Says It Is Incremental Win For Biogen

The move centralizes Biogen's presence in Kendall Square, integrating Biogen's research and development and technical operations teams alongside its global and North American commercial organizations into a co-located innovation hub.

Biogen Plans For Its New Global Headquarters At Kendall Common, Located At 75 Broadway In Cambridge

The Association of the British Pharmaceutical Industry (ABPI) is urging ministers to address excessive levies on manufacturers to ensure the sector remains competitive globally.
The life sciences industry, a key pillar of the UK&#8217;s economic strategy, could struggle to attract investment unless payment rates are adjusted.
Last week, the government <a href="https://www.abpi.org.uk/media/news/2025/march/uk-set-to-demand-a-third-of-pharmaceutical-company-revenue-in-second-half-of-2025/" target="_blank" rel="noreferrer noopener">proposed</a> raising the Statutory Scheme payment rate for newer branded medicines from 15.5% to 32.2% of subject companies&#8217; National Health Service (NHS) sales in the second half of 2025.
The payment rate is the revenue companies must hand back to the government on their sales of branded medicines to the NHS. It is an additional charge to the taxes paid by companies.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/03/44362710/uk-pharma-industry-trade-association-restores-wegovyozempic-maker-novo-nordisks-membership-after-two-years-of-suspension" rel="noreferrer noopener">UK Pharma Industry Trade Association Restores Wegovy/Ozempic Maker Novo Nordisk&#8217;s Membership After 2 Years Of Suspension</a>
UK pharmaceutical leaders from Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Biogen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), Boehringer Ingelheim, Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>), Gilead Sciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), Roche Holdings AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>), Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>), Takeda Pharmaceutical Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TAK#NYSE">TAK</a>) and UCB SA (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJY#OTC">UCBJY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/UCBJF#OTC">UCBJF</a>) point to the challenges to investing in the U.K.
The pharmaceutical sector <a target="_blank" href="https://www.abpi.org.uk/media/news/2025/march/medicine-levy-makes-the-uk-un-investable-say-pharma-leaders/" rel="noreferrer noopener">contributes</a> over 17.6 billion pounds ($22.76 billion) directly to the U.K. economy, with an additional 45 billion generated through research and development spillovers.
However, companies argue that growth is being stifled due to escalating mandatory payments. Under the current system, firms must pay between 23.5% and 35.6% of their branded medicine sales revenue to the NHS. This is significantly higher than other European nations, where comparable rates range from 5.7% to 9%, ABPI writes.
The ABPI report highlights that while the UK once led in medicine availability, it has slipped to ninth place in Europe over the past decade. One year after launch, medicine usage in England is only 52% of the average of comparable nations, rising to 62% after five years.
Additionally, the UK has dropped from fourth to tenth in global rankings for phase 3 clinical trials, lagging behind Spain, Germany and Italy.
Investment in UK pharmaceutical research has also declined, with the country&#8217;s share of global R&amp;D investment falling from 7.3% to 5.7% in just three years.
This marks the fastest decline of any European G7 nation. Meanwhile, NHS funding has grown by 33% in real terms over the past decade, but spending on branded medicines has been capped at annual growth rates between 1.1% and 2%, declining by 11% when adjusted for inflation.
The industry and government have long collaborated on agreements to ensure NHS access to medicines.
The latest, the Voluntary Scheme for Branded Medicines, Pricing, Access, and Growth (VPAG), was intended to realign UK payment rates with international standards. While rates for newer medicines briefly dropped to 15.1% in 2024, they surged again in 2025 to 23.5% for newer medicines, with companies still paying 10.6%-35.6% for older products.
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Photo: Shutterstock

Eurozone

DSNKY

RHHBY

UCBJF

UCBJY

Pharmaceutical Firms Say UK Investment Is 'Unlikely' Unless Payment Levy Is Adressed

On Wednesday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) announced safety and efficacy results from the Phase 3 program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of patients aged two to &lt;18 years with <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">spinal muscular atrophy (SMA)</a>.
In the Phase 3 STEER study, <a target="_blank" href="https://www.novartis.com/news/media-releases/new-novartis-phase-iii-data-demonstrate-meaningful-efficacy-and-safety-results-intrathecal-onasemnogene-abeparvovec-broad-patient-population-sma" rel="noreferrer noopener">treatment</a> with OAV101 IT led to a statistically significant 2.39-point improvement on the Hammersmith Functional Motor Scale Expanded (HFMSE), an assessment of motor ability and disease progression, vs. 0.51 points in the sham control arm.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43629559/novartis-to-beef-up-heart-disease-offering-with-3-billion-blackstone-backed-anthos-therapeutics-deal" rel="noreferrer noopener">Novartis To Beef Up Heart Disease Offering With $3 Billion Blackstone-Backed Anthos Therapeutics Deal</a>
Novartis <a target="_blank" href="https://www.novartis.com/news/media-releases/novartis-intrathecal-onasemnogene-abeparvovec-phase-iii-study-meets-primary-endpoint-children-and-young-adults-sma" rel="noreferrer noopener">released</a> topline data from the Phase 3 STEER study in December 2024.
In the Phase 3b STRENGTH study, treatment with OAV101 IT in patients who have discontinued treatment with Biogen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) Spinraza (nusinersen) or Roche Holdings AG&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Evrysdi (risdiplam) demonstrated stabilization of motor function over 52 weeks of follow-up.
The results add to the growing body of evidence within the OAV101 IT development program, which has evaluated a broad population of over 170 patients with SMA, spanning a total of over 6.4 years across the STEER, STRENGTH, and Phase 1/2 STRONG studies.
OAV101 IT is an investigational gene replacement therapy designed to directly address the genetic root cause of the disease by replacing the nonworking&nbsp;SMN1 gene with a single dose.
In the registrational STEER study, efficacy and safety were studied in treatment naïve patients with SMA Type 2, aged two to less than 18 years, who could sit but had never walked independently. Key findings:
<ul>
<li>The trial met its primary endpoint of change from baseline to 52 weeks in HFMSE score, with OAV101 IT demonstrating a statistically significant 2.39-point improvement on the HFMSE vs 0.51 points in the sham group.</li>
<li>All secondary endpoints consistently favor OAV101 IT, despite not achieving statistical significance due to the pre-planned multiple testing procedure.</li>
</ul>
The open-label Phase 3b STRENGTH study evaluated the safety, tolerability and efficacy of OAV101 IT in patients with SMA aged two to less than 18 years who had discontinued treatment with nusinersen or risdiplam.&nbsp;Key findings:
<ul>
<li>OAV101 IT demonstrated a favorable safety profile that was consistent with the STEER study.</li>
<li>The motor endpoint of efficacy, HFMSE, demonstrated stabilization for the overall study population over 52 weeks. The increase from baseline to 52 weeks in HFMSE least squares (LS) total score was 1.05.</li>
</ul>
Price Action: NVS stock is down 0.75% at $111.38 at the last check Wednesday.
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Photo by Taljat David via Shutterstock

Novartis New Data From Single-Dose Gene Therapy Shows Meaningful Efficacy, Safety In Patients With Spinal Muscular Atrophy

Biogen Begins Phase 3 Study Of Felzartamab For The Treatment Of Late Antibody-Mediated Rejection (AMR) In Kidney Transplant Patients

Investors with a lot of money to spend have taken a bullish stance on Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>).
And retail traders should know.
We noticed this today when the trades showed up on publicly available options history that we track here at Benzinga.
Whether these are institutions or just wealthy individuals, we don't know. But when something this big happens with BIIB, it often means somebody knows something is about to happen.
So how do we know what these investors just did? 
Today, <a href="https://www.benzinga.com/pro/">Benzinga</a>'s options scanner spotted 32 uncommon options trades for Biogen.
This isn't normal.
The overall sentiment of these big-money traders is split between 37% bullish and 31%, bearish.
Out of all of the special options we uncovered, 25 are puts, for a total amount of $1,440,538, and 7 are calls, for a total amount of $248,991.
<h3>What's The Price Target?</h3>
After evaluating the trading volumes and Open Interest, it's evident that the major market movers are focusing on a price band between $110.0 and $165.0 for Biogen, spanning the last three months.
<h3>Volume &amp; Open Interest Development</h3>
Examining the volume and open interest provides crucial insights into stock research. This information is key in gauging liquidity and interest levels for Biogen's options at certain strike prices. Below, we present a snapshot of the trends in volume and open interest for calls and puts across Biogen's significant trades, within a strike price range of $110.0 to $165.0, over the past month.
<h3>Biogen Option Volume And Open Interest Over Last 30 Days</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1741635034_0.png" alt="Options Call Chart" />
<h3>Biggest Options Spotted:</h3>

<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Ask</th>
<th>Bid</th>
<th>Price</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th align="right">Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>BIIB</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>07/18/25</td>
<td>$6.3</td>
<td>$2.7</td>
<td>$3.44</td>
<td>$125.00</td>
<td>$68.8K</td>
<td align="right">130</td>
<td>6.7K</td>
</tr>
<tr>
<td>BIIB</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>07/18/25</td>
<td>$6.3</td>
<td>$2.7</td>
<td>$3.44</td>
<td>$125.00</td>
<td>$68.8K</td>
<td align="right">130</td>
<td>7.2K</td>
</tr>
<tr>
<td>BIIB</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>07/18/25</td>
<td>$6.3</td>
<td>$2.7</td>
<td>$3.44</td>
<td>$125.00</td>
<td>$68.8K</td>
<td align="right">130</td>
<td>5.2K</td>
</tr>
<tr>
<td>BIIB</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>07/18/25</td>
<td>$6.3</td>
<td>$2.7</td>
<td>$3.44</td>
<td>$125.00</td>
<td>$68.8K</td>
<td align="right">130</td>
<td>5.2K</td>
</tr>
<tr>
<td>BIIB</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>07/18/25</td>
<td>$6.3</td>
<td>$2.7</td>
<td>$3.43</td>
<td>$125.00</td>
<td>$68.6K</td>
<td align="right">130</td>
<td>5.6K</td>
</tr>
</tbody>
</table>

<h3>About Biogen</h3>
Biogen and Idec merged in 2003, combining forces to market Biogen's multiple sclerosis drug Avonex and Idec's cancer drug Rituxan. Today, Rituxan and next-generation antibody Gazyva (oncology) and Ocrevus (multiple sclerosis) are marketed via a collaboration with Roche. Biogen markets several multiple sclerosis drugs including Plegridy, Tysabri, Tecfidera, and Vumerity. Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys (Friedreich's Ataxia, Reata), Zurzuvae (postpartum depression, Sage), and Qalsody (ALS, Ionis). Biogen has several drug candidates in phase 3 trials in neurology, immunology, and rare diseases.
In light of the recent options history for Biogen, it's now appropriate to focus on the company itself. We aim to explore its current performance.
<h3>Where Is Biogen Standing Right Now?</h3>
<ul>
<li>Trading volume stands at 1,501,013, with BIIB's price up by 0.01%, positioned at $150.39.</li>
<li>RSI indicators show the stock to be is currently neutral between overbought and oversold.</li>
<li>Earnings announcement expected in 44 days.</li>
</ul>
<h3>Expert Opinions on Biogen</h3>
In the last month, 5 experts released ratings on this stock with an average target price of $199.2.
Turn $1000 into $1270 in just 20 days?
20-year pro options trader reveals his one-line chart technique that shows when to buy and sell. Copy his trades, which have had averaged a 27% profit every 20 days. <a href="https://www.benzinga.com/premium/ideas/options-moneyline-2/?t=Moop1arja3be22op14&amp;adType=benzinga-insights&amp;ad=options-activity&amp;campaign=wallstreetadvantage">Click here for access</a>. 
&#x2A; An analyst from RBC Capital has decided to maintain their Outperform rating on Biogen, which currently sits at a price target of $225. 
&#x2A; An analyst from Goldman Sachs has decided to maintain their Buy rating on Biogen, which currently sits at a price target of $245. 
&#x2A; An analyst from Citigroup has decided to maintain their Neutral rating on Biogen, which currently sits at a price target of $145. 
&#x2A; An analyst from Wells Fargo persists with their Equal-Weight rating on Biogen, maintaining a target price of $140. 
&#x2A; Consistent in their evaluation, an analyst from HC Wainwright &amp; Co. keeps a Buy rating on Biogen with a target price of $241. 
Options are a riskier asset compared to just trading the stock, but they have higher profit potential. Serious options traders manage this risk by educating themselves daily, scaling in and out of trades, following more than one indicator, and following the markets closely.
If you want to stay updated on the latest options trades for Biogen, <a href="https://www.benzinga.com/pro/">Benzinga Pro</a> gives you real-time options trades alerts.

Options

Markets

Decoding Biogen's Options Activity: What's the Big Picture?

Biogen's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NYSE">BIIB</a>) short percent of float has risen 3.1% since its last report. The company recently reported that it has 3.88 million shares sold short, which is 2.99% of all regular shares that are available for trading. Based on its trading volume, it would take traders 2.35 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>Biogen Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1741368622_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Biogen has grown since its last report. This does not mean that the stock is going to fall in the near-term but traders should be aware that more shares are being shorted.
<h3>Comparing Biogen's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, Biogen's peer group average for short interest as a percentage of float is 5.55%, which means the company has less short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

Short Sellers

Short Ideas

Trading Ideas

How Is The Market Feeling About Biogen?

The National Institute for Health and Care Excellence (NICE) has reaffirmed its stance against recommending Alzheimer&#8217;s treatments donanemab and lecanemab for NHS use, citing <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">insufficient cost-effectiveness</a>.
Despite additional evidence submitted by manufacturers, the independent appraisal committee <a target="_blank" href="https://www.nice.org.uk/news/articles/second-consultation-launched-on-nhs-funding-for-alzheimer-s-treatments" rel="noreferrer noopener">concluded</a> that the treatments do not provide enough benefit to justify their significant cost.
NICE first raised concerns about these treatments last year, determining that their clinical benefits did not outweigh the financial burden they would place on the NHS.
Read Next: <a target="_blank" href="https://www.benzinga.com/25/03/44171941/denali-therapeutics-ends-als-trial-extension-analyst-stays-optimistic-despite-trial-setback" rel="noreferrer noopener">Denali Therapeutics Ends ALS Trial Extension, Analyst Stays Optimistic Despite Trial Setback</a>
Although the U.K.&#8217;s Medicines and Healthcare Products Regulatory Agency (MHRA) approved Eli Lilly&#8217;s Kisunla (donanemab) in October, NICE <a target="_blank" href="https://www.benzinga.com/top-stories/24/10/41498770/eli-lilly-alzheimers-drug-faces-tough-road-in-uk-price-watchdog-nice-says-donanemab-is-not-cost-effe" rel="noreferrer noopener">refused&nbsp;to cover it</a>.
The agency ruled that the cost of providing donanemab balanced against the relatively small benefit cannot currently be considered good value for the taxpayer.
In August, MHRA approved Biogen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40514109/biogens-alzheimers-drug-secures-uk-approval-but-an-independent-agency-does-not-recommend-reimburs" rel="noreferrer noopener">Leqembi (lecanemab)</a>.
Despite the approval, NICE said in its guidance draft,&#8221;&nbsp;benefits of the new Alzheimer&#8217;s drug lecanemab are too small to justify the costs.&#8221;
Following a request for further data, the latest assessment has reinforced that donanemab and lecanemab remain economically unviable for NHS funding.
&#8220;Cost and evidence gaps remain barriers to approving funding in the NHS for donanemab and lecanemab,&#8221; the agency says in its statement.
Stakeholders are encouraged to contribute their perspectives before the consultation period closes on March 27, 2025.
A third committee meeting will review all responses and additional analyses before NICE issues its final recommendations.
Price Action: At the last check on Thursday, BIIB stock was up 1.50% at $145.92, and LLY stock was down 2.82% at $903.84.
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Photo via Shutterstock

Alzheimer's Drugs From Eli Lilly And Biogen Still Deemed Too Costly For NHS Funding

High-rolling investors have positioned themselves bullish on Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>), and it's important for retail traders to take note. 
\This activity came to our attention today through Benzinga's tracking of publicly available options data. The identities of these investors are uncertain, but such a significant move in BIIB often signals that someone has privileged information.
Today, Benzinga's options scanner spotted 12 options trades for Biogen. This is not a typical pattern.
The sentiment among these major traders is split, with 25% bullish and 25% bearish. Among all the options we identified, there was one put, amounting to $30,042, and 11 calls, totaling $746,086.
<h3>Expected Price Movements</h3>
Taking into account the Volume and Open Interest on these contracts, it appears that whales have been targeting a price range from $100.0 to $180.0 for Biogen over the last 3 months. 
<h3>Volume &amp; Open Interest Development</h3>
Looking at the volume and open interest is a powerful move while trading options. This data can help you track the liquidity and interest for Biogen's options for a given strike price. Below, we can observe the evolution of the volume and open interest of calls and puts, respectively, for all of Biogen's whale trades within a strike price range from $100.0 to $180.0 in the last 30 days. 
<h3>Biogen Call and Put Volume: 30-Day Overview</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1741111264_0.png" alt="Options Call Chart" />
<h3>Significant Options Trades Detected:</h3>

<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Ask</th>
<th>Bid</th>
<th>Price</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th align="right">Open Interest</th>
<th align="right">Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>BIIB</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>03/21/25</td>
<td>$27.2</td>
<td>$26.0</td>
<td>$26.0</td>
<td>$120.00</td>
<td>$260.0K</td>
<td align="right">872</td>
<td align="right">100</td>
</tr>
<tr>
<td>BIIB</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>03/21/25</td>
<td>$51.3</td>
<td>$47.0</td>
<td>$47.0</td>
<td>$100.00</td>
<td>$141.1K</td>
<td align="right">30</td>
<td align="right">30</td>
</tr>
<tr>
<td>BIIB</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>03/21/25</td>
<td>$27.1</td>
<td>$26.0</td>
<td>$26.0</td>
<td>$120.00</td>
<td>$62.4K</td>
<td align="right">872</td>
<td align="right">124</td>
</tr>
<tr>
<td>BIIB</td>
<td>CALL</td>
<td>SWEEP</td>
<td>NEUTRAL</td>
<td>04/17/25</td>
<td>$10.5</td>
<td>$10.0</td>
<td>$10.22</td>
<td>$140.00</td>
<td>$51.1K</td>
<td align="right">197</td>
<td align="right">118</td>
</tr>
<tr>
<td>BIIB</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>03/21/25</td>
<td>$22.1</td>
<td>$17.2</td>
<td>$20.35</td>
<td>$125.00</td>
<td>$40.9K</td>
<td align="right">75</td>
<td align="right">22</td>
</tr>
</tbody>
</table>

<h3>About Biogen</h3>
Biogen and Idec merged in 2003, combining forces to market Biogen's multiple sclerosis drug Avonex and Idec's cancer drug Rituxan. Today, Rituxan and next-generation antibody Gazyva (oncology) and Ocrevus (multiple sclerosis) are marketed via a collaboration with Roche. Biogen markets several multiple sclerosis drugs including Plegridy, Tysabri, Tecfidera, and Vumerity. Biogen's newer products include Spinraza (SMA, with partner Ionis), Leqembi (Alzheimers, with partner Eisai), Skyclarys (Friedreich's Ataxia, Reata), Zurzuvae (postpartum depression, Sage), and Qalsody (ALS, Ionis). Biogen has several drug candidates in phase 3 trials in neurology, immunology, and rare diseases.
Following our analysis of the options activities associated with Biogen, we pivot to a closer look at the company's own performance.
<h3>Present Market Standing of Biogen</h3>
<ul>
<li>With a volume of 1,409,926, the price of BIIB is up 1.32% at $143.57. </li>
<li>RSI indicators hint that the underlying stock may be approaching overbought.</li>
<li>Next earnings are expected to be released in 50 days.</li>
</ul>
<h3>What Analysts Are Saying About Biogen</h3>
A total of 5 professional analysts have given their take on this stock in the last 30 days, setting an average price target of $201.0.
Unusual Options Activity Detected: Smart Money on the Move
Benzinga Edge's Unusual Options board spots potential market movers before they happen. See what positions big money is taking on your favorite stocks. <a href="https://www.benzinga.com/premium/ideas/benzinga-edge-checkout/?t=Be8be9arja3be22bz20&amp;adType=benzinga-insights&amp;ad=options-activity&amp;campaign=wallstreetadvantage">Click here for access</a>. 
&#x2A; Maintaining their stance, an analyst from Scotiabank continues to hold a Sector Outperform rating for Biogen, targeting a price of $224. 
&#x2A; An analyst from Canaccord Genuity has decided to maintain their Buy rating on Biogen, which currently sits at a price target of $265. 
&#x2A; An analyst from HC Wainwright &amp; Co. has decided to maintain their Buy rating on Biogen, which currently sits at a price target of $241. 
&#x2A; An analyst from Wells Fargo has decided to maintain their Equal-Weight rating on Biogen, which currently sits at a price target of $140. 
&#x2A; Reflecting concerns, an analyst from Piper Sandler lowers its rating to Neutral with a new price target of $135.
Options are a riskier asset compared to just trading the stock, but they have higher profit potential. Serious options traders manage this risk by educating themselves daily, scaling in and out of trades, following more than one indicator, and following the markets closely.
If you want to stay updated on the latest options trades for Biogen, <a href="https://www.benzinga.com/pro/">Benzinga Pro</a> gives you real-time options trades alerts.

What the Options Market Tells Us About Biogen

<a href="https://www.eisai.com/news/2025/pdf/enews202515pdf.pdf">https://www.eisai.com/news/2025/pdf/enews202515pdf.pdf</a>
&nbsp;
– Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that the Therapeutic Goods Administration (TGA) of Australia has confirmed the initial decision to decline the approval of humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab (generic name) as a treatment for early Alzheimer's disease (AD) (mild cognitive impairment due to AD and mild AD dementia). In October 2024, the TGA made the decision not to register lecanemab in Australia for the treatment of patients with early AD. In December 2024, Eisai requested reconsideration of the decision, proposing to the TGA the same apolipoprotein E4 (ApoE4) noncarrier and heterozygote indication that was agreed by the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA). In the course of the reconsideration of the initial decision, the TGA proposed an alternative narrow therapeutic indication only for ApoE4 noncarriers as an increasing number of ApoE4 alleles is a potential risk factor for ARIA. They did not agree that safety has been established for ApoE4 heterozygotes. Eisai proposed alternative indications, one of which was to maintain the ApoE4 noncarrier and heterozygote indication, but with heterozygotes treated in specialist centers and supervised by physicians with expertise in treatment of AD and monitoring for ARIA; however, the TGA rejected our proposal.

Eisai  and Biogen Announces That The Therapeutic Goods Administration Of Australia Has Confirmed The Initial Decision To Decline The Approval Of Humanized Anti-Soluble Aggregated Amyloid-Beta  Monoclonal Antibody Lecanemab As A Treatment For Early Alzheimer's Disease

<a href="https://investors.biogen.com/news-releases/news-release-details/committee-medicinal-products-human-use-chmp-reaffirms-positive">https://investors.biogen.com/news-releases/news-release-details/committee-medicinal-products-human-use-chmp-reaffirms-positive</a> Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has reaffirmed its positive opinion by consensus for the anti-Aβ monoclonal antibody lecanemab, adopted in November 2024.1 Following CHMP's reaffirmation, after having considered the additional information requested by the European Commission (EC), the EC will resume the decision-making process for lecanemab's marketing authorization.
In January 2025, as part of its decision-making process, the EC asked the CHMP to consider information on the safety of lecanemab that became available after the adoption of the CHMP opinion in November 2024 and whether this may require an update of the opinion, and to consider whether the wording of the risk minimization measures in the opinion is clear enough to ensure correct implementation. After reviewing the additional information, the CHMP concluded that its positive opinion for lecanemab does not need to be updated.
Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and AD dementia currently affects an estimated 15.2 million and 6.9 million people in Europe, respectively.2 AD progresses over time in stages with increasingly severe symptoms that greatly impact not only those who are living with AD, but also their loved ones, care partners and society. There is a significant unmet need for new treatment options that slow down the progression of AD from its early stage.
If the EC approves the lecanemab marketing authorization application, the approval will apply to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Eisai and Biogen will continue to make every effort to deliver lecanemab to patients with early AD in Europe as soon as possible.
Eisai serves as the lead for lecanemab's development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

Global

The CHMP Reaffirms Positive Opinion For Lecanemab In Early Alzheimer's Disease

A cost-saving effort by NHS England to transition multiple sclerosis (MS) patients from Biogen Inc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) Tysabri (natalizumab) to the biosimilar drug Tyruko has led to significant side effects.
At Charing Cross Hospital in London, about 170 multiple sclerosis patients experienced complications, including relapses, mobility issues, fatigue, pain, and weight gain. Some cases were severe enough to require hospitalization.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43792922/biogen-strengthens-pipeline-with-stoke-therapeutics-dravet-syndrome-candidate-via-multi-million-dollar-deal" rel="noreferrer noopener">Biogen Strengthens Pipeline With Stoke Therapeutic&#8217;s Dravet Syndrome Candidate Via Multi-Million Dollar Deal</a>
According to The Guardian report, NHS England has been rolling out biosimilar drugs like Tyruko since April, aiming to cut costs by using alternatives to patented medications. Biosimilars are designed to be as effective and safe as the original drugs but are considerably cheaper—Tyruko costs an average of 72% <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43673992/biogen-delivers-q4-beat-analyst-focuses-on-leqembi-expansion-2025-outlook" rel="noreferrer noopener">less than Tysabri</a>.
Sandoz Group AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/SDZXF#OTC">SDZXF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/SDZNY#OTC">SDZNY</a>), a generic spin-off of Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), manufactures Tyruko. As per The Guardian <a target="_blank" href="https://www.theguardian.com/society/2025/feb/24/ms-patients-suffer-side-effects-after-nhs-england-switches-to-cheaper-drug" rel="noreferrer noopener">report</a>, the initiative is part of a broader strategy to save $1.26 billion (1 billion pounds) over five years on medication expenses.
The extent of the issue remains unclear. NHS England has stated that problems have only been observed at Charing Cross, but one patient claims that individuals at 15 other hospitals have also experienced negative effects from the switch.
Approximately half of the NHS hospitals treating MS patients are currently participating in the transition to Tyruko.
Due to growing concerns, NHS England is now discussing with the Department of Health and Social Care and the Medicines and Healthcare products Regulatory Agency to assess the situation and determine potential next steps.
Imperial College Healthcare NHS Trust, which oversees Charing Cross Hospital, initially had 345 patients on Tysabri. When the transition to Tyruko began in May, the trust anticipated mild, short-term side effects but was unprepared for the severity and persistence of complications. About half of the affected patients reported worsening symptoms over several months. In response, all have now been switched back to Tysabri.
Price Action: BIIB stock is up 0.19% at $140.91 at the last check Monday.
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The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

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