Peptide News Digest

#Biib

3 stories

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Eisai (TSE: 4523) and Biogen (NASDAQ: BIIB) Announced Wednesday August 26, 2026 That Once-Weekly Subcutaneous Lecanemab-Irmb (Brand Name Leqembi Iqlik) Is Now Commercially Available in the United States for Initiation Therapy in Adults With Early Alzheimer's Disease (Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease); The US Launch Represents the Anti-Amyloid Monoclonal Antibody Class's Substantive Transition From the Existing Twice-Monthly Intravenous Infusion Format to a Weekly Subcutaneous Injection That Substantially Improves Patient Accessibility and Reduces the Infrastructure Burden (Infusion Center Scheduling, Long Chair Time, IV Line Placement) That Has Constrained the Ongoing Global Leqembi Launch Since Initial 2023 FDA Approval

Eisai (TSE: 4523) and Biogen (NASDAQ: BIIB) announced Wednesday August 26, 2026 that once-weekly subcutaneous lecanemab-irmb (brand name Leqembi Iqlik) is now commercially available in the United States for initiation therapy in adults with early Alzheimer's disease (AD). Approved patient population: adults with mild cognitive impairment (MCI) or mild dementia due to AD, the same patient population that was approved for the IV formulation. Mechanism: lecanemab is a humanized IgG1 monoclonal antibody targeting soluble amyloid-beta protofibrils and preventing their aggregation into amyloid plaques that drive Alzheimer's pathology. Delivery format shift: the US launch represents the anti-amyloid class's substantive transition from the existing twice-monthly IV infusion format (requiring 1 hour of infusion time plus monitoring) to a weekly subcutaneous injection that substantially improves patient accessibility and reduces the infrastructure burden that has constrained the ongoing global Leqembi launch. Practical impact on Leqembi commercial trajectory: the SC format removes several barriers including infusion center scheduling constraints, long chair time per dose, and IV line placement complications. Eisai and Biogen have been struggling with slower-than-expected Leqembi launch since initial 2023 FDA approval due to reimbursement complexity, MRI monitoring requirements for amyloid-related imaging abnormalities (ARIA), and infrastructure requirements; the SC availability addresses one substantive barrier. Q2 2026 Leqembi worldwide sales reached roughly $340 million; the SC transition is expected to accelerate the commercial trajectory in Q4 2026 and into 2027.

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Biogen (NASDAQ: BIIB) and Chinese Partner TJ Biopharma Announced Monday August 17, 2026 That Felzartamab for Injection (Branded Jingfei in China) an Anti-CD38 Monoclonal Antibody Has Been Approved by China's National Medical Products Administration (NMPA) for Use With Lenalidomide and Dexamethasone in Adults With Multiple Myeloma Who Have Received at Least One Prior Line of Therapy; Felzartamab Represents an Alternative Anti-CD38 Mechanism to Sanofi's SARCLISA (Isatuximab) and J&J's DARZALEX (Daratumumab) That Have Anchored the Anti-CD38 Multiple Myeloma Commercial Segment; The China Approval Marks TJ Biopharma's First Regional Commercial Launch for Felzartamab and Extends the Biogen-China Partnership Approach for Both Ex-China Drug Development and In-China Commercial Positioning

Biogen (NASDAQ: BIIB) and Chinese partner TJ Biopharma announced Monday August 17, 2026 that felzartamab for injection (branded Jingfei in China), an anti-CD38 monoclonal antibody, has been approved by China's National Medical Products Administration (NMPA) for use with lenalidomide and dexamethasone in adults with multiple myeloma who have received at least one prior line of therapy. Anti-CD38 mechanism context: CD38 is a transmembrane glycoprotein highly expressed on multiple myeloma plasma cells and less on normal cells, making it a validated target for monoclonal antibody therapy. Felzartamab represents an alternative anti-CD38 mechanism to Sanofi's SARCLISA (isatuximab) and Johnson & Johnson's DARZALEX (daratumumab), the two commercial anti-CD38 monoclonal antibodies that have anchored the anti-CD38 multiple myeloma commercial segment since first approvals in 2015 (daratumumab) and 2020 (isatuximab). Felzartamab's specific differentiation lies in a distinct epitope-binding domain on CD38 that may translate to different infusion-reaction profiles and combination-therapy potential. The China NMPA approval marks TJ Biopharma's first regional commercial launch for felzartamab and extends the Biogen-China partnership approach for both ex-China drug development and in-China commercial positioning. Beyond multiple myeloma, felzartamab is being studied for anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis), IgA nephropathy, and antibody-mediated kidney transplant rejection in ex-China trials that Biogen leads.

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Biogen (NASDAQ: BIIB) Reports Q2 2026 Earnings Before Market Open Wednesday July 29 With Revenue of $2.74 Billion (+3% Year-Over-Year), GAAP EPS $0.66, and Non-GAAP EPS $3.60 Beating Wall Street Consensus, Plus FDA Approval Announced for LEQEMBI IQLIK (Lecanemab-Irmb Subcutaneous Autoinjector) at-Home Initiation Dosing; The May 14, 2026 Apellis Acquisition Contributed $128 Million in Combined SYFOVRE (Pegcetacoplan Intravitreal) and EMPAVELI (Pegcetacoplan Subcutaneous) Partial-Quarter Revenue With Estimated Run-Rate Synergies of at Least $250 Million Exiting 2027

Biogen (NASDAQ: BIIB) reported Q2 2026 earnings before market open Wednesday July 29, 2026 with total revenue of $2.74 billion (+3% year-over-year), GAAP diluted EPS of $0.66, and non-GAAP diluted EPS of $3.60, beating Wall Street consensus. Growth-portfolio drugs (LEQEMBI, SKYCLARYS, SYFOVRE, and EMPAVELI) delivered year-over-year growth and, in aggregate, growth-portfolio revenue exceeded $1 billion for the quarter, surpassing Biogen's legacy multiple sclerosis franchise. Two major pipeline milestones anchored the earnings call: the FDA approved LEQEMBI IQLIK (lecanemab-irmb, a subcutaneous autoinjector formulation) for at-home initiation dosing (following the earlier approval of LEQEMBI IQLIK for maintenance dosing), providing patient-friendly dosing throughout the treatment course; and the Apellis acquisition that closed May 14, 2026 contributed $128 million in combined SYFOVRE (pegcetacoplan intravitreal, for geographic atrophy) and EMPAVELI (pegcetacoplan subcutaneous, for paroxysmal nocturnal hemoglobinuria and C3 glomerulopathy) revenue in the partial quarter. Biogen expects approximately 0.85 EPS dilution from the Apellis acquisition in 2026 with accretion in 2027 and estimated run-rate synergies of at least $250 million exiting 2027. 2026 revenue guidance raised to mid-single-digit growth with non-GAAP EPS guidance of $12-13.