에 대한 최신 뉴스 Biogen (NASDAQ:BIIB) 주식

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.

Cambridge,,Ma,,Usa,-,June,29,,2022:,Biogen,Logo,Is

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BIIB

수요일 바이오젠(NASDAQ:BIIB)은 4분기 조정 주당순이익(EPS)이 $3.44로 17% 증가하여 컨센서스 3.35달러를 초과했다고 보고했다. 이 회사는 매출이 24.6억 달러로 전년 대비 2% 증가(환율 변동 제외)하고 3% 증가(보고 기준)하여 컨센서스 24.0억 달러를 초과했다고 보고했다.

바이오젠, 4분기 실적 상회, 분석가는 레켐비 확장, 2025년 전망에 초점

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신규 블록 세이지 테라퓨틱스(NASDAQ:SAGE)는 주주들을 만족시키기 위한 &#34;전략적 대안&#34;을 공식적으로 탐색하고 있다. 이 과정에는 가능한 사업 결합부터 전면적인 매각까지 모든 것이 포함된다.

딜 디스패치: 세이지와 실버스가 매각 중, 미스터비스트가 틱톡을 위해 20억 달러를 확보

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대통령 조 바이든은 백악관에서의 마지막 며칠 동안 비폭력 마약 범죄자 석방를 우선시했지만, 틱톡? 이제는 대통령 당선자 도널드 트럼프의 문제이다. AP 통신에 따르면, 바이든은 금지 조치를 시행할 의사가 없으며, 이는 그의 마지막 정식 근무일인 1월 19일에 발효되고 트럼프의 취임식 하루 전이다.

딜 디스패치: 바이든이 틱톡 금지를 트럼프에게 넘기고, 또 다른 유명 소매업체 파산

Biogen Inc

RBC Capital analyst Brian Abrahams maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Outperform and lowers the price target from $217 to $205.

Price Target

RBC Capital Maintains Outperform on Biogen, Lowers Price Target to $205

Canaccord Genuity analyst Sumant Kulkarni maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Buy and lowers the price target from $265 to $220.

Canaccord Genuity Maintains Buy on Biogen, Lowers Price Target to $220

HC Wainwright &amp; Co. analyst Andrew Fein maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Buy and lowers the price target from $241 to $187.

HC Wainwright & Co. Maintains Buy on Biogen, Lowers Price Target to $187

Baird analyst Brian Skorney maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Outperform and lowers the price target from $300 to $255.

Baird Maintains Outperform on Biogen, Lowers Price Target to $255

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

Reiteration

Needham Reiterates Hold on Biogento Hold

Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) reported on Thursday that the first quarter of 2025 adjusted earnings per share was $3.02. That&#8217;s down from $3.67 a year ago, beating <a href="https://www.benzinga.com/calendars/earnings" target="_blank" rel="noreferrer noopener">the analyst consensus of $2.52</a>.
The company <a href="https://investors.biogen.com/static-files/cbd0307c-c394-4d4a-a388-c7511bbacb8f" target="_blank" rel="noreferrer noopener">reported</a> sales of $2.43 billion, up 6% year over year on a reported basis, 8% on constant currency, beating the consensus of $2.23 billion.
Multiple sclerosis revenue of $953 million decreased by 11% (down 10% on constant currency). The multiple sclerosis drug Tysabri sales were down to $381.5 million&nbsp;<a href="https://www.benzinga.com/general/biotech/25/02/43635908/what-to-expect-from-alzheimers-drugmaker-biogens-q4-earnings-on-wednesday" target="_blank" rel="noreferrer noopener">from $431.3 million</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44652995/vertex-alnylam-best-positioned-as-biopharma-braces-for-tariff-impact-goldman-sachs-analyst-flags-regeneron-biogen-risks" rel="noreferrer noopener">Vertex, Alnylam Best Positioned As Biopharma Braces For Tariff Impact, Goldman Sachs Flags Regeneron, Biogen Risks</a>
Rare disease revenue&nbsp;increased&nbsp;33% year over year (up 36% on constant currency) to $563 million. Spinraza&#8217;s revenue increased to $423.9 million from $341.3 million a year ago.
Revenues from Skyclarys, acquired via Reata acquisition, reached $123.9 million during the quarter, up from $78 million a year ago.
U.S. Skyclarys revenue of approximately $69 million was impacted by expected Medicare discount dynamics partially offset by demand growth.
In Alzheimer&#8217;s disease, Biogen said Leqembi&#8217;s first quarter global in-market sales of approximately $96 million, including U.S. in-market sales of approximately $52 million, representing continued sequential growth.
Guidance:&nbsp;Biogen lowers full year 2025 adjusted <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43659412/biogen-warns-lower-2025-revenue-inks-rd-funding-pact-with-royalty-pharma-for-late-stage-lupus-asset" rel="noreferrer noopener">EPS outlook from $15.25-$16.25</a>&nbsp;to $14.50-$15.50 versus a consensus of $4.92.
The guidance reflects the ~($0.95) impact from a $165 million upfront transaction payment to Stoke related to the collaboration agreement for zorevunersen in Dravet syndrome, partially offset by a $0.20 benefit mainly from foreign exchange.
For 2025, Biogen expects total revenue to decline by a mid-single-digit percentage. Further declines in multiple sclerosis product revenues are expected to be partially offset by increases in revenue from product launches.
Potential tariffs are not expected to significantly affect the company&#8217;s 2025 financial outlook, even if the current exemption for pharmaceuticals ends:
Many of its products sold in the U.S. are made domestically
It has strong global inventory levels. However, Biogen notes that the future of U.S. and international tariffs is still unclear, and its forecast does not account for any new tariffs that might be introduced.
In April, the European Commission approved&nbsp;Eisai Co., Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ESALY#OTC">ESALY</a>) and&nbsp;Biogen&#8217;s amyloid-beta (Aβ) monoclonal&nbsp;<a target="_blank" href="https://www.benzinga.com/25/04/44846884/europe-approves-eisai-biogens-alzheimers-drug-under-strict-conditions-after-initial-negative-opinion" rel="noreferrer noopener">antibody Leqembi&nbsp;(lecanemab)</a>. The Commission said it&nbsp;<a target="_blank" href="https://ec.europa.eu/newsroom/sante/items/879055/en?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">granted</a>&nbsp;the approval under strict conditions.
Price Action:&nbsp;BIIB stock is up 0.80% at $122.05 at $130&nbsp;at the last check on Thursday.
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<li><a href="https://www.benzinga.com/news/25/05/45139492/kellanova-misses-q1-revenue-and-earnings-estimates-due-to-weak-global-demand-and-currency-pressure" target="_blank" rel="noreferrer noopener">Kellanova Misses Q1 Revenue And Earnings Estimates Due To Weak Global Demand And Currency Pressure</a></li>
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Image: Shutterstock

ESALY

Biogen Beats Q1 Earnings Expectations As Two Newcomer Drug Sales Spike, Avoids Tariff Impact

Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) lowers FY2025 Adj EPS guidance from $15.25-$16.25 to $14.50-$15.50 vs $14.92 analyst estimate..

Biogen Lowers FY2025 Adj EPS Guidance from $15.25-$16.25 to $14.50-$15.50 vs $14.92 Est

Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) reported quarterly earnings of $3.02 per share which beat the analyst consensus estimate of $2.52 by 19.84 percent. This is a 17.71 percent decrease over earnings of $3.67 per share from the same period last year. The company reported quarterly sales of $2.43 billion which beat the analyst consensus estimate of $2.23 billion by 8.85 percent. This is a 6.11 percent increase over sales of $2.29 billion the same period last year.

Earnings Beats

Biogen Q1 Adj. EPS $3.02 Beats $2.52 Estimate, Sales $2.43B Beat $2.23B Estimate

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Earnings Scheduled For May 1, 2025

Truist Securities analyst Srikripa Devarakonda maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Buy and lowers the price target from $210 to $199.

Truist Securities Maintains Buy on Biogen, Lowers Price Target to $199

Piper Sandler analyst Christopher Raymond maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Neutral and lowers the price target from $135 to $115.

Piper Sandler Maintains Neutral on Biogen, Lowers Price Target to $115

Goldman Sachs analyst Salveen Richter maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Buy and lowers the price target from $219 to $197.

Goldman Sachs Maintains Buy on Biogen, Lowers Price Target to $197

14 analysts have shared their evaluations of Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) during the recent three months, expressing a mix of bullish and bearish perspectives.
The following table summarizes their recent ratings, shedding light on the changing sentiments within 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">4</td>
<td align="right">3</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">1</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">1</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
<tr>
<td>2M 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>3M Ago</td>
<td align="right">4</td>
<td align="right">2</td>
<td align="right">6</td>
<td align="right">0</td>
<td align="right">0</td>
</tr>
</tbody>
</table>
Analysts' evaluations of 12-month price targets offer additional insights, showcasing an average target of $190.21, with a high estimate of $265.00 and a low estimate of $135.00. Highlighting a 9.82% decrease, the current average has fallen from the previous average price target of $210.93. 
<img src="https://www.benzinga.com/files/images/story/2025/1745359228_0.png" alt="price target chart" />
<h2>Diving into Analyst Ratings: An In-Depth Exploration</h2>
A comprehensive examination of how financial experts perceive Biogen is derived from recent analyst actions. The following is a detailed summary of key analysts, their recent evaluations, and adjustments to ratings and price targets.
&#x7C; Analyst &#x7C; Analyst Firm &#x7C; Action Taken &#x7C; Rating &#x7C;Current Price Target&#x7C; Prior Price Target &#x7C; 
&#x7C;--------------------&#x7C;--------------------&#x7C;---------------&#x7C;-----------------&#x7C;--------------------&#x7C;--------------------&#x7C; 
&#x7C;Brian Abrahams &#x7C;RBC Capital &#x7C;Raises &#x7C;Outperform &#x7C; $225.00&#x7C;$221.00 &#x7C; 
&#x7C;Matthew Harrison &#x7C;Morgan Stanley &#x7C;Lowers &#x7C;Equal-Weight &#x7C; $152.00&#x7C;$157.00 &#x7C; 
&#x7C;Christopher Raymond &#x7C;Piper Sandler &#x7C;Lowers &#x7C;Neutral &#x7C; $135.00&#x7C;$138.00 &#x7C; 
&#x7C;George Farmer &#x7C;Scotiabank &#x7C;Lowers &#x7C;Sector Outperform&#x7C; $224.00&#x7C;$244.00 &#x7C; 
&#x7C;Evan Seigerman &#x7C;BMO Capital &#x7C;Lowers &#x7C;Market Perform &#x7C; $139.00&#x7C;$156.00 &#x7C; 
&#x7C;Matthew Harrison &#x7C;Morgan Stanley &#x7C;Lowers &#x7C;Equal-Weight &#x7C; $157.00&#x7C;$192.00 &#x7C; 
&#x7C;Salveen Richter &#x7C;Goldman Sachs &#x7C;Lowers &#x7C;Buy &#x7C; $245.00&#x7C;$281.00 &#x7C; 
&#x7C;Brian Abrahams &#x7C;RBC Capital &#x7C;Lowers &#x7C;Outperform &#x7C; $225.00&#x7C;$231.00 &#x7C; 
&#x7C;Geoff Meacham &#x7C;Citigroup &#x7C;Lowers &#x7C;Neutral &#x7C; $145.00&#x7C;$160.00 &#x7C; 
&#x7C;Mohit Bansal &#x7C;Wells Fargo &#x7C;Lowers &#x7C;Equal-Weight &#x7C; $140.00&#x7C;$165.00 &#x7C; 
&#x7C;Andrew Fein &#x7C;HC Wainwright &amp; Co. &#x7C;Lowers &#x7C;Buy &#x7C; $241.00&#x7C;$300.00 &#x7C; 
&#x7C;Srikripa Devarakonda&#x7C;Truist Securities &#x7C;Lowers &#x7C;Buy &#x7C; $210.00&#x7C;$220.00 &#x7C; 
&#x7C;Sumant Kulkarni &#x7C;Canaccord Genuity &#x7C;Lowers &#x7C;Buy &#x7C; $265.00&#x7C;$298.00 &#x7C; 
&#x7C;Geoff Meacham &#x7C;Citigroup &#x7C;Lowers &#x7C;Neutral &#x7C; $160.00&#x7C;$190.00 &#x7C;
<h3>Key Insights:</h3>
<ul>
<li>Action Taken: Analysts respond to changes in market conditions and company performance, frequently updating their recommendations. Whether they 'Maintain', 'Raise' or 'Lower' their stance, it reflects their reaction to recent developments related to Biogen. This information offers a snapshot of how analysts perceive the current state of the company.</li>
<li>Rating: Analysts unravel qualitative evaluations for stocks, ranging from 'Outperform' to 'Underperform'. These ratings offer insights into expectations for the relative performance of Biogen compared to the broader market.</li>
<li>Price Targets: Analysts gauge the dynamics of price targets, providing estimates for the future value of Biogen's stock. This comparison reveals trends in analysts' expectations over time.</li>
</ul>
For valuable insights into Biogen's market performance, consider these analyst evaluations alongside crucial financial indicators. Stay well-informed and make prudent decisions using 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>Get to Know Biogen Better</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>A Deep Dive into Biogen's Financials</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 remarkable performance in 3M is evident. As of 31 December, 2024, the company achieved an impressive revenue growth rate of 2.87%. This signifies 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: Biogen's net margin is below industry standards, pointing towards difficulties in achieving strong profitability. With a net margin of 10.86%, the company may encounter 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): The company's ROA is a standout performer, exceeding industry averages. With an impressive ROA of 0.95%, the company showcases effective utilization of assets.
Debt Management: The company maintains a balanced debt approach with a debt-to-equity ratio below industry norms, standing at 0.4.
<h2>The Basics of Analyst Ratings</h2>
Benzinga tracks 150 analyst firms and reports on their stock expectations. Analysts typically arrive at their conclusions by predicting how much money a company will make in the future, usually the upcoming five years, and how risky or predictable that company's revenue streams are.
Analysts attend company conference calls and meetings, research company financial statements, and communicate with insiders to publish their ratings on stocks. Analysts typically rate each stock once per quarter or whenever the company has a major update.
Some analysts also offer predictions for helpful metrics such as earnings, revenue, and growth estimates to provide further guidance as to what to do with certain tickers. It is important to keep in mind that while stock and sector analysts are specialists, they are also human and can only forecast their beliefs to traders.
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This article was generated by Benzinga's automated content engine and reviewed by an editor.

14 Analysts Have This To Say About Biogen

RBC Capital analyst Brian Abrahams maintains Biogen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) with a Outperform and raises the price target from $221 to $225.

RBC Capital Maintains Outperform on Biogen, Raises Price Target to $225

US President Donald Trump issued a multi-part executive order on Tuesday to lower drug prices and <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">reduce Medicare costs</a>.
Within 60 days, the Secretary of Health and Human Services is instructed to seek guidance for the Medicare Drug Price Negotiation Program for initial price applicability year 2028 and how drugmakers should implement the set prices in 2026, 2027, and 2028.
<ul>
<li>This guidance will focus on greater transparency, selecting high-cost drugs, and safeguarding pharmaceutical innovation.</li>
<li>Additionally, the administration seeks to eliminate a key disparity in how Medicare treats small-molecule drugs compared to biologics, discouraging investment in more affordable treatments.</li>
</ul>
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44724763/pharma-industry-faces-jitters-as-trump-hints-at-historic-tariffs-bofa-outlines-probable-timeline" rel="noreferrer noopener">Pharma Industry Faces Jitters As Trump Hints At Historic Tariffs, BofA Outlines Probable Timeline</a>
The White House is also <a target="_blank" href="https://www.whitehouse.gov/presidential-actions/2025/04/lowering-drug-prices-by-once-again-putting-americans-first/" rel="noreferrer noopener">targeting</a> the rising costs seniors face under Medicare. A new payment model will be tested within a year to obtain better value for high-cost drugs and biologicals, including those not subject to price negotiations.
Further, the administration wants to align Medicare payments with actual hospital acquisition costs through a national survey, with potential reimbursement adjustments following the results.
To reform Medicaid drug pricing, the administration will develop recommendations linking drug payments to their value and ensuring accurate rebate payments from manufacturers. The initiative also aims to assist states in managing spending while promoting innovation in Medicaid reimbursement.
Affordability for life-saving medications is another key focus: Community health centers will be required to offer insulin and epinephrine at or below discounted 340B prices to low-income individuals with high out-of-pocket costs or no insurance, with compliance tied to eligibility for future federal grants..
To address price manipulation in the supply chain, the administration calls for reevaluating middlemen roles, such as pharmacy benefit managers, and seeking transparency in their compensation structures. Within 90 days, recommendations to promote a more efficient pharmaceutical market are expected.
Other planned reforms include accelerating FDA approvals for generics and over-the-counter conversions, streamlining the drug importation program, and ensuring Medicare payments do not incentivize hospital-based care over less costly physician offices.
Lastly, federal agencies will investigate anti-competitive practices by drug manufacturers, with public listening sessions and policy recommendations expected within six months.
Read Next:
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<li><a href="https://www.benzinga.com/analyst-ratings/price-target/25/04/44826592/netflix-wants-to-be-the-next-1-trillion-company-analyst-highlights-growth-path" target="_blank" rel="noreferrer noopener">Netflix Wants To Be The Next $1 Trillion Company, Analyst Highlights Growth Path</a></li>
</ul>
Photo by Aria Armoko via Shutterstock

Government

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Trump's New Order Targets Drug Pricing Transparency And Medicare Cost Reduction

The European Commission (EC) on Tuesday approved Eisai Co., Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/ESALY#OTC">ESALY</a>) and Biogen Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) amyloid-beta (Aβ) monoclonal <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">antibody Leqembi&nbsp;(lecanemab)</a>,
The Commission said it <a target="_blank" href="https://ec.europa.eu/newsroom/sante/items/879055/en" rel="noreferrer noopener">granted</a> the approval under strict conditions.
Lecanemab is indicated for adult patients with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/g44829126/leqembi-lecanemab-is-the-first-medicine-that-slows-progression-of-early-alzheimers-disease-to-be-a" rel="noreferrer noopener">confirmed amyloid pathology</a>.
Lecanemab is the only approved Aβ monoclonal antibody that preferentially binds and clears toxic protofibrils&nbsp;(soluble Aβ aggregates) and targets and reduces Aβ plaques (insoluble Aβ aggregates).
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&#8217;s Drugs From Eli Lilly And Biogen Still Deemed Too Costly For NHS Funding</a>
Protofibrils are a key toxic form of Aβ that accumulate in the brain and cause neuronal injury.
MCI due to AD and AD dementia currently affect an estimated 15.2 million and 6.9 million people in Europe, respectively.
Eisai leads lecanemab&#8217;s development and regulatory submissions globally. Biogen and Eisai co-commercialize and co-promote the product. Eisai has final decision-making authority.
In the EU (excluding the Nordic countries), Eisai and Biogen will co-promote the medicine, with Eisai distributing the product as the MA Holder.
In the Nordic countries, Eisai and BioArctic will co-promote the medicine, with Eisai distributing the product as the marketing application holder Holder.
In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion for&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39985709/biogeneisais-alzheimers-drug-leqembi-gets-no-go-from-european-drug-regulators-advisory-panel-cite" rel="noreferrer noopener">lecanemab approval</a>.
The committee&nbsp;<a target="_blank" href="https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-july-2024?tblci=GiCUX7wvU_AgmIIiQduNYr6JQuJQLy6SZJGvpyeZuCzyqiCN1VcoxvTN4f7-y-PqATDviEo" rel="noreferrer noopener">considered</a> that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular, the frequent occurrence of amyloid-related imaging abnormalities involving swelling and potential bleedings in the brain of patients who received Leqembi.
After re-examining its <a target="_blank" href="https://www.ema.europa.eu/en/news/leqembi-recommended-treatment-early-alzheimers-disease" rel="noreferrer noopener">initial</a> opinion, in November 2024, CHMP recommended granting marketing authorization.
Earlier this year, the FDA accepted Eisai and Biogen&#8217;s Biologics License Application (BLA) for lecanemab subcutaneous autoinjector for <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/42973945/fda-to-review-under-the-skin-weekly-autoinjector-for-biogen-eisais-alzheimers-drug-leqembi" rel="noreferrer noopener">weekly maintenance dosing</a>.
A Prescription Drug User Fee Act (PDUFA) action date is August 31, 2025.
Biogen said Leqembi&#8217;s fourth-quarter global in-market sales of approximately $87 million, including U.S. in-market sales of approximately $50 million, represented good <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43659412/biogen-warns-lower-2025-revenue-inks-rd-funding-pact-with-royalty-pharma-for-late-stage-lupus-asset" rel="noreferrer noopener">continued sequential growth</a>.
In March, the CHMP issued an opinion that does not recommend that Eli Lilly and Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>) donanemab be granted marketing authorization for early symptomatic Alzheimer&#8217;s disease. Lilly said it would seek <a target="_blank" href="https://www.benzinga.com/25/03/44544761/european-drug-regulator-gives-thumbs-down-to-eli-lillys-alzheimers-drug-analyst-says-it-is-incremental-win-for-bi" rel="noreferrer noopener">re-examination by the 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&#8217;s disease (AD), which includes mild cognitive impairment (MCI) or mild dementia stage of disease.
Price Action: BIIB stock is up 0.46% at $117.52 at the last check on Wednesday.
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Photo by JHVEPhoto via Shutterstock

Europe Approves Eisai-Biogen's Alzheimer's Drug 'Under Strict Conditions' After Initial Negative Opinion

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.

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

Press Releases

GeneDx Reports Fourth Quarter and Full Year 2024 Financial Results and Issues Guidance for Full Year 2025

Biogen and Stoke Therapeutics Enter into Collaboration to Develop and Commercialize Zorevunersen for the Treatment of Dravet Syndrome, a Rare Genetic Epilepsy Associated with Refractory Seizures and Neurodevelopmental Impairments

The Committee for Medicinal Products for Human Use (CHMP) Reaffirms Positive Opinion for Lecanemab in Early Alzheimer's Disease

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Biogen Announces Plans for New Global Headquarters and Innovation Hub in Kendall Square

Organon Acquires TOFIDENCE™ (tocilizumab-bavi), a Commercialized Biosimilar to ACTEMRA® (tocilizumab) Injection, for Intravenous Infusion in the U.S.

Biogen's Investigational Tau-Targeting Therapy BIIB080 Receives FDA Fast Track Designation for the Treatment of Alzheimer's Disease

Leqembi®∇ (lecanemab) is the First Medicine that Slows Progression of Early Alzheimer's Disease to be Authorized in the European Union

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