Eisai Finalizes Rolling Submission of sBLA for Leqembi Iqlik to the FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 25 2025
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Should l Buy BIIB?
Eisai and Biogen Collaboration: Eisai Co. has completed the rolling submission of the Supplemental Biologics License Application (sBLA) for Leqembi Iqlik to the U.S. FDA, in partnership with Biogen.
FDA Fast Track Status: The FDA granted Fast Track Status to Leqembi, which is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment or mild dementia.
Next Steps with FDA: Upon acceptance of the sBLA, the FDA will establish a Prescription Drug User Fee Act (PDUFA) action date for the application.
Leqembi's Indication: Leqembi is specifically aimed at patients in the early stages of Alzheimer's disease, focusing on those with Mild Cognitive Impairment or mild dementia.
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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: 189.180
Low
143.00
Averages
204.45
High
246.00
Current: 189.180
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.
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- Stock Price Surge: Shares of Alteogen Inc. rose approximately 6% in South Korea, closing at 381,000 won, reflecting market optimism regarding the exclusive licensing agreement with Biogen, indicating strong investor confidence in the company's future prospects.
- Deal Details: Under the agreement, Biogen gains rights to develop and commercialize ALT-B4 using Hybrozyme technology, with a total deal value of up to $579 million, highlighting Biogen's recognition of the technology's potential market value.
- Upfront Payments and Milestones: Alteogen will receive an upfront payment of $20 million and an additional $10 million upon the initiation of the second product's development, along with potential milestone payments of up to $549 million, significantly enhancing the company's liquidity.
- Future Revenue Streams: Following commercialization, Alteogen will be entitled to royalties based on net sales, providing a continuous revenue stream that could further enhance the company's market position through the success of future products.
See More
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- Agreement Signing: Alteogen has entered into an exclusive license agreement with Biogen to develop subcutaneously delivered biologics, marking a significant collaboration in the biopharmaceutical sector.
- Product Development Focus: The agreement centers on ALT-B4, a human hyaluronidase product designed to convert intravenously delivered biologics into more convenient subcutaneous formulations, enhancing patient experience.
- Expected Cash Inflow: Alteogen will receive $20 million upfront, with an additional $10 million upon the initiation of studies for the second product, alongside potential milestone payments of up to $549 million, significantly bolstering the company's financial position.
- Significant Market Potential: Biogen will gain exclusive rights to develop and commercialize two ALT-B4-based biologics, which is expected to enhance its competitiveness in the biopharmaceutical market, particularly in the rapidly growing subcutaneous delivery segment.
See More
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Company Announcement: Alteogen Inc. has announced a new agreement to develop a third product.
Focus on Biogen: The development will be conducted in collaboration with Biogen, indicating a strategic partnership.
See More
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Partnership Announcement: Alteogen has entered into a licensing agreement with Biogen for the development and commercialization of Hybromyze™.
Product Focus: The agreement specifically pertains to Hybromyze™, which is based on subcutaneous biologics.
See More
Real-World LEQEMBI Data Shows Patients Choose to Stay on Long-Term Treatment
- High Treatment Persistence: In the Phase III Clarity AD study, 94% of patients who completed 18 months of treatment chose to continue in the long-term extension study, indicating strong patient reliance and trust in LEQEMBI, which reinforces the drug's significance in Alzheimer's treatment.
- Significant Long-Term Effects: Patients in the extension study benefited from four years of lecanemab treatment, showing better clinical outcomes compared to the natural progression of Alzheimer's disease, thereby enhancing market confidence in the drug's efficacy.
- Patient Characteristics Analysis: The analysis included 10,763 individuals with a mean age of 73.8 years, 56.5% of whom were female, with common comorbidities such as dyslipidemia and hypertension, providing critical insights for the drug's indications and market positioning.
- Strong Adherence Rates: Among 371 patients followed for the long term, 78.4% remained on lecanemab at 18 months, 71.7% at 20 months, and 67.3% at 24 months, demonstrating excellent patient adherence and supporting its potential for clinical application.
See More
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- High Patient Persistence: In the Phase III Clarity AD study, 94% of patients who completed 18 months of treatment chose to continue in the long-term extension study, indicating significant long-term adherence to LEQEMBI among chronic disease patients, which may enhance clinical outcomes and patient satisfaction.
- Significant Long-Term Effects: Among 371 patients followed, 78.4% remained on LEQEMBI at 18 months, 71.7% at 20 months, and 67.3% at 24 months, demonstrating the drug's persistence in real-world settings and its potential positive impact on the natural course of Alzheimer's disease.
- Patient Characteristics Analysis: The analysis included 10,763 patients with a mean age of 73.8 years, 56.5% of whom were female, with common comorbidities like dyslipidemia and hypertension, and an average follow-up duration of 350.9 days, suggesting the drug's applicability across diverse patient demographics and enhancing its market potential.
- Global Regulatory Progress: LEQEMBI has been approved in 53 countries and regions and is under regulatory review in 6 countries, reflecting broad global recognition and future growth potential, particularly in the strategic landscape of Alzheimer's disease treatment.
See More
