FDA To Review Under the Skin Weekly Autoinjector For Biogen/Eisai's Alzheimer's Drug Leqembi
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 14 2025
0mins
Should l Buy BIIB?
Source: Benzinga
FDA Acceptance of Lecanemab Application: The FDA has accepted the Biologics License Application for lecanemab-irmb (Leqembi) subcutaneous autoinjector for Alzheimer’s disease, with a PDUFA action date set for August 31, 2025. If approved, it will be the first home-administered treatment for Alzheimer's using an autoinjector.
Biogen's Acquisition Bid: Biogen has made an unsolicited bid to acquire Sage Therapeutics for $7.22 per share, which analysts view as a strategic move following the successful launch of Zurzuvae for postpartum depression.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy BIIB?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on BIIB
Wall Street analysts forecast BIIB stock price to rise
26 Analyst Rating
11 Buy
14 Hold
1 Sell
Moderate Buy
Current: 189.280
Low
143.00
Averages
204.45
High
246.00
Current: 189.280
Low
143.00
Averages
204.45
High
246.00
About BIIB
Biogen Inc. is a global biopharmaceutical company. The Company is focused on discovering, developing, and delivering advanced therapies for people living with serious and complex diseases worldwide. It operates a portfolio of medicines to treat multiple sclerosis (MS), spinal muscular atrophy (SMA), Alzheimer's disease, and amyotrophic lateral sclerosis (ALS). It is focused on advancing its pipeline in neurology, specialized immunology, and rare diseases. Its marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of Friedreich's Ataxia; QALSODY for the treatment of ALS, and FUMADERM for the treatment of severe plaque psoriasis. It also collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of Postpartum Depression (PPD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Eli Lilly Reports Strong Q1 Performance with Revenue Surge
- Significant Revenue Growth: Eli Lilly reported Q1 revenue of $19.8 billion, a 56% year-over-year increase that surpassed the market expectation of $17.6 billion, demonstrating strong performance in the obesity drug market and reinforcing investor confidence in the stock.
- Earnings Surge: Adjusted earnings per share reached $8.55, more than doubling from last year and exceeding the consensus estimate of $6.66, indicating the company's ability to achieve profitability despite declining drug prices.
- Competitive Market Dynamics: Despite competition from Novo Nordisk, CEO David Ricks emphasized that the company can overcome price declines through higher volumes, with U.S. drug prices down 7% but volumes up 49%, showcasing strong demand for its GLP-1 products.
- New Drug Launch and Market Outlook: The recently launched obesity drug Foundayo received FDA approval and became available quickly; although initial growth has been slow, 80% of prescriptions are from patients who had not previously used GLP-1 drugs, suggesting potential to expand the market size.
See More
Biogen Reports Earnings Beat, Shares Surge 6%
- Earnings Beat: Biogen reported total revenue of $2.48 billion for Q1 2026, reflecting a 2% year-over-year increase that surpassed the consensus estimate of $2.25 billion, demonstrating resilience in a competitive biotech landscape.
- Profitability Improvement: The company's attributable net income rose by 19% to $529 million, or $3.57 per share, significantly exceeding analysts' expectations of $2.95 per share, indicating a notable enhancement in profitability.
- Sales Growth: Sales of Leqembi surged by 74% to $168 million, serving as a key driver for revenue growth, while Skyclarys also exhibited strong double-digit growth, showcasing Biogen's success in new drug development.
- Guidance Cut: Despite the strong earnings report, Biogen lowered its full-year adjusted net income guidance to $14.25 to $15.25 per share, down $1 from the previous forecast of $15.25 to $16.25, reflecting the impact of R&D expenses, although the ongoing acquisition of Apellis Pharmaceuticals is expected to further strengthen the company's market position.
See More
Biogen Q1 2026 Earnings Call Highlights
- Strong Revenue Growth: Biogen reported total revenue of $2.5 billion in Q1 2026, reflecting a 2% year-over-year increase, with growth products contributing $850 million, up 12%, indicating enhanced market competitiveness and product demand.
- Market Opportunity for LEQEMBI: The company anticipates launching the subcutaneous formulation of LEQEMBI on the PDUFA date of May 24, which is expected to improve patient convenience and strengthen its competitive position against Kisunla, further solidifying its role in Alzheimer's treatment.
- Acquisition Outlook: Biogen's proposed acquisition of Apellis is expected to be accretive by 2027, highlighting the company's strategic intent to expand commercial growth and enhance its nephrology portfolio, thereby driving future revenue growth.
- Cash Flow and Financial Health: The company generated $594 million in free cash flow during the quarter, with total cash and marketable securities reaching $4.7 billion and net debt at $1.5 billion, demonstrating robust financial health and ongoing investment capacity.
See More
Regeneron and Biogen See High Options Trading Volume
- Regeneron Options Volume: Regeneron Pharmaceuticals, Inc. recorded options trading volume of 3,177 contracts, representing approximately 317,700 shares, which is about 47.9% of its average daily trading volume of 663,385 shares over the past month, indicating strong market interest in its future performance.
- High Call Option Activity: Within Regeneron, the $795 strike call option is particularly active, with 1,091 contracts traded today, representing approximately 109,100 shares, reflecting investor expectations for a price increase.
- Biogen Options Trading: Biogen Inc. saw options trading volume of 5,898 contracts, equating to approximately 589,800 shares, or about 43.3% of its average daily trading volume of 1.4 million shares over the past month, demonstrating significant market interest in its stock.
- Active Put Option Trading: For Biogen, the $170 strike put option has seen trading of 1,509 contracts, representing approximately 150,900 shares, indicating investor concerns regarding potential price declines.
See More
Market Preview: Tech Giants Earnings Day
- Fed Rate Decision: The Federal Reserve is expected to keep interest rates unchanged this afternoon, with market participants closely watching Chair Powell's press conference, which could influence investor confidence in the economy's future.
- Tech Giants Earnings: Alphabet, Amazon, Meta, and Microsoft are set to report earnings after the bell, with high expectations for Alphabet's cloud and advertising growth, while Amazon must discuss more than just its cloud success to maintain its stock price.
- Seagate Strong Performance: Seagate reported a strong quarter that exceeded expectations, driven by surging demand for data storage technology in the AI era, with its stock up 600% over the past year and an additional 16% increase today.
- Visa Quarterly Results: Visa's quarterly performance was robust, with limited disruption from the Middle East, announcing a $20 billion buyback plan and projecting low double-digit to low-teens revenue growth for the year, resulting in a stock price increase of over 5%.
See More
Biogen Q1 Earnings Exceed Expectations
- Earnings Beat: Biogen reported a Q1 non-GAAP EPS of $3.57, exceeding expectations by $0.62, which reflects the company's strong market performance and boosts investor confidence.
- Revenue Growth: The company achieved Q1 revenue of $2.48 billion, a 2.1% year-over-year increase, surpassing market expectations by $230 million, indicating stability in product sales and market demand.
- 2026 Earnings Outlook Adjustment: Biogen now expects its 2026 non-GAAP diluted EPS to range between $14.25 and $15.25, below the consensus of $15.55, highlighting the impact of acquired IPR&D charges on profitability and raising concerns about future growth.
- Revenue Forecast Downgrade: The company anticipates a mid-single-digit percentage decline in total revenue for 2026 compared to 2025, suggesting that Biogen faces market challenges and will need to implement strategic measures to navigate future uncertainties.
See More
Eli Lilly Reports Strong Q1 Performance with Revenue Surge
- Significant Revenue Growth: Eli Lilly reported Q1 revenue of $19.8 billion, a 56% year-over-year increase that surpassed the market expectation of $17.6 billion, demonstrating strong performance in the obesity drug market and reinforcing investor confidence in the stock.
- Earnings Surge: Adjusted earnings per share reached $8.55, more than doubling from last year and exceeding the consensus estimate of $6.66, indicating the company's ability to achieve profitability despite declining drug prices.
- Competitive Market Dynamics: Despite competition from Novo Nordisk, CEO David Ricks emphasized that the company can overcome price declines through higher volumes, with U.S. drug prices down 7% but volumes up 49%, showcasing strong demand for its GLP-1 products.
- New Drug Launch and Market Outlook: The recently launched obesity drug Foundayo received FDA approval and became available quickly; although initial growth has been slow, 80% of prescriptions are from patients who had not previously used GLP-1 drugs, suggesting potential to expand the market size.
See More
Biogen Reports Earnings Beat, Shares Surge 6%
- Earnings Beat: Biogen reported total revenue of $2.48 billion for Q1 2026, reflecting a 2% year-over-year increase that surpassed the consensus estimate of $2.25 billion, demonstrating resilience in a competitive biotech landscape.
- Profitability Improvement: The company's attributable net income rose by 19% to $529 million, or $3.57 per share, significantly exceeding analysts' expectations of $2.95 per share, indicating a notable enhancement in profitability.
- Sales Growth: Sales of Leqembi surged by 74% to $168 million, serving as a key driver for revenue growth, while Skyclarys also exhibited strong double-digit growth, showcasing Biogen's success in new drug development.
- Guidance Cut: Despite the strong earnings report, Biogen lowered its full-year adjusted net income guidance to $14.25 to $15.25 per share, down $1 from the previous forecast of $15.25 to $16.25, reflecting the impact of R&D expenses, although the ongoing acquisition of Apellis Pharmaceuticals is expected to further strengthen the company's market position.
See More
Biogen Q1 2026 Earnings Call Highlights
- Strong Revenue Growth: Biogen reported total revenue of $2.5 billion in Q1 2026, reflecting a 2% year-over-year increase, with growth products contributing $850 million, up 12%, indicating enhanced market competitiveness and product demand.
- Market Opportunity for LEQEMBI: The company anticipates launching the subcutaneous formulation of LEQEMBI on the PDUFA date of May 24, which is expected to improve patient convenience and strengthen its competitive position against Kisunla, further solidifying its role in Alzheimer's treatment.
- Acquisition Outlook: Biogen's proposed acquisition of Apellis is expected to be accretive by 2027, highlighting the company's strategic intent to expand commercial growth and enhance its nephrology portfolio, thereby driving future revenue growth.
- Cash Flow and Financial Health: The company generated $594 million in free cash flow during the quarter, with total cash and marketable securities reaching $4.7 billion and net debt at $1.5 billion, demonstrating robust financial health and ongoing investment capacity.
See More
Regeneron and Biogen See High Options Trading Volume
- Regeneron Options Volume: Regeneron Pharmaceuticals, Inc. recorded options trading volume of 3,177 contracts, representing approximately 317,700 shares, which is about 47.9% of its average daily trading volume of 663,385 shares over the past month, indicating strong market interest in its future performance.
- High Call Option Activity: Within Regeneron, the $795 strike call option is particularly active, with 1,091 contracts traded today, representing approximately 109,100 shares, reflecting investor expectations for a price increase.
- Biogen Options Trading: Biogen Inc. saw options trading volume of 5,898 contracts, equating to approximately 589,800 shares, or about 43.3% of its average daily trading volume of 1.4 million shares over the past month, demonstrating significant market interest in its stock.
- Active Put Option Trading: For Biogen, the $170 strike put option has seen trading of 1,509 contracts, representing approximately 150,900 shares, indicating investor concerns regarding potential price declines.
See More
Market Preview: Tech Giants Earnings Day
- Fed Rate Decision: The Federal Reserve is expected to keep interest rates unchanged this afternoon, with market participants closely watching Chair Powell's press conference, which could influence investor confidence in the economy's future.
- Tech Giants Earnings: Alphabet, Amazon, Meta, and Microsoft are set to report earnings after the bell, with high expectations for Alphabet's cloud and advertising growth, while Amazon must discuss more than just its cloud success to maintain its stock price.
- Seagate Strong Performance: Seagate reported a strong quarter that exceeded expectations, driven by surging demand for data storage technology in the AI era, with its stock up 600% over the past year and an additional 16% increase today.
- Visa Quarterly Results: Visa's quarterly performance was robust, with limited disruption from the Middle East, announcing a $20 billion buyback plan and projecting low double-digit to low-teens revenue growth for the year, resulting in a stock price increase of over 5%.
See More
Biogen Q1 Earnings Exceed Expectations
- Earnings Beat: Biogen reported a Q1 non-GAAP EPS of $3.57, exceeding expectations by $0.62, which reflects the company's strong market performance and boosts investor confidence.
- Revenue Growth: The company achieved Q1 revenue of $2.48 billion, a 2.1% year-over-year increase, surpassing market expectations by $230 million, indicating stability in product sales and market demand.
- 2026 Earnings Outlook Adjustment: Biogen now expects its 2026 non-GAAP diluted EPS to range between $14.25 and $15.25, below the consensus of $15.55, highlighting the impact of acquired IPR&D charges on profitability and raising concerns about future growth.
- Revenue Forecast Downgrade: The company anticipates a mid-single-digit percentage decline in total revenue for 2026 compared to 2025, suggesting that Biogen faces market challenges and will need to implement strategic measures to navigate future uncertainties.
See More
