Regulatory Filings and Drug Development - Biogen announced that the FDA and EMA have accepted its regulatory filings for a higher dose of Spinraza, a blockbuster spinal muscular atrophy (SMA) drug [1] - The new dosing regimen simplifies administration with two initial 50 mg doses spaced 14 days apart, followed by a 28 mg maintenance dose every four months, reducing dosing frequency compared to the current regimen [2] - The regulatory filings are supported by data from the phase II/III DEVOTE study, which showed statistically significant improvement in motor function in infants with SMA treated with a higher dose of Spinraza [3] - A higher dose regimen has the potential to slow neurodegeneration faster through greater reductions in neurofilament as early as day 64, potentially leading to meaningful clinical benefits in infants with symptomatic SMA [4] Spinraza's Market Position and Competition - Spinraza, a key revenue driver for Biogen, was developed jointly with Ionis Pharmaceuticals, with Biogen holding worldwide rights for its development, manufacturing, and commercialization [7] - Spinraza faces competition from Novartis' Zolgensma and Roche/PTC Therapeutics' Evrysdi, both approved for SMA, which has negatively impacted Spinraza's sales in the United States [7][8] - Spinraza's sales declined almost 3% year over year in 2023 and over 13% in the first nine months of 2024 due to increased competitive pressure [8] Biogen's Collaborations and Pipeline - Biogen and Ionis have a collaboration agreement for Qalsody (tofersen), which received FDA accelerated approval in April 2023 for treating adult patients with SOD1-ALS and was also approved in the EU [10] - Biogen and Ionis are collaborating to develop new therapies for neurological diseases, including BIIB094 for Parkinson's disease and BIIB080 for Alzheimer's disease, currently in early to mid-stage studies [11] Stock Performance - Biogen's shares have lost nearly 42% in the past year, compared to the industry's 12% decline [5]

Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher dose regimen of nusinersen to advance the treatment of SMACAMBRIDGE, Mass., Jan. 23, 2025 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and the European Medicines Agency (EMA) has validated the application for a higher dose regimen of nusinersen for spinal muscular a ...

Biogen Inc. Conference Call Summary Company Overview - **Company**: Biogen Inc. (NASDAQ:BIIB) - **Event**: J.P. Morgan 43rd Annual Healthcare Conference - **Date**: January 14, 2025 - **Participants**: - Chris Viehbacher - President and CEO of Biogen - Chris Schott - JPMorgan Key Points Industry Focus - **Alzheimer's Disease**: Biogen is focusing on addressing the significant unmet need in Alzheimer's, indicating a substantial commercial opportunity in this area [4] Product Launches - **Recent Launches**: Biogen executed four product launches in the previous year, which include: - LEQEMBI - SKYCLARYS - ZURZUVAE - QALSODY - The company is prioritizing strong execution on these launches in the near term [3] Pipeline Development - **Pipeline Confidence**: Biogen has made significant progress in its pipeline, with internal conviction and confidence noted regarding its potential [5] Long-term Strategy - **Focus Areas**: Biogen's long-term strategy includes a strong commitment to Alzheimer's treatment and further development of its pipeline [4] Additional Insights - **Market Opportunities**: The emphasis on Alzheimer's suggests that Biogen is positioning itself to capitalize on a growing market with high demand for effective treatments [4] - **Execution Strategy**: The focus on executing product launches indicates a proactive approach to market penetration and revenue generation [3]

TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for the ...

TOKYO and CAMBRIDGE, Mass., Jan. 13, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (NASDAQ:BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen")) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for the ...

Acquisition Proposal - Biogen has made an unsolicited, non-binding proposal to acquire Sage Therapeutics for $7.22 per share, representing a 30% premium over Sage's closing price of $5.55 on Friday [1] - Biogen currently owns a 10.2% stake in Sage Therapeutics [1] - Sage Therapeutics' board will review and evaluate the offer [1] Stock Performance - Sage Therapeutics' stock surged 46% in after-hours trading following the news, while Biogen's shares declined slightly [2] - Over the past year, Biogen's shares have declined 40%, and Sage Therapeutics' stock has dropped 79.1%, compared to a 15.9% decrease in the industry [2] Zurzuvae Collaboration - Sage Therapeutics and Biogen have a collaboration for the commercialization of Zurzuvae, approved for postpartum depression (PPD) in August 2023 [3] - The companies equally share profits and losses for Zurzuvae in the US, while Biogen records product sales in non-US markets (excluding Japan, Taiwan, and South Korea) and pays royalties to Sage [4] - Zurzuvae has not yet been approved in the EU [4] Zurzuvae Development Setback - The FDA issued a complete response letter for Zurzuvae's major depressive disorder (MDD) indication in August 2023, requesting additional clinical studies [5] - In October 2024, the companies decided not to pursue further development of Zurzuvae for MDD due to the need for more time and investment [6] - If Biogen acquires Sage Therapeutics, it will gain full ownership of Zurzuvae, which has been outperforming launch expectations [6] Pipeline Setbacks - Sage Therapeutics discontinued the development of dalzanemdor (SAGE-718) for all indications in November 2024 after mid-stage studies failed to meet primary endpoints [8] - Biogen terminated its rights under the collaboration agreement for SAGE-324 (BIIB124) in essential tremor (ET) after a phase II study failed in July 2024 [9] Zacks Rank & Biotech Stocks - Sage Therapeutics has a Zacks Rank 2 (Buy), while Biogen has a Zacks Rank 3 (Hold) [10] - Top-ranked biotech stocks include Puma Biotechnology (PBYI) and Castle Biosciences (CSTL), both with a Zacks Rank 1 (Strong Buy) [10] - Castle Biosciences' 2025 earnings estimates have narrowed from a loss of $1.88 per share to a loss of $1.84 per share, with shares surging 51.0% over the past year [11] - Puma Biotechnology's 2025 earnings per share estimates have increased from 52 cents to 55 cents, despite a 33.1% decline in shares over the past year [11] - Castle Biosciences has beaten earnings estimates in each of the trailing four quarters, with an average surprise of 172.72% [11] - Puma Biotechnology has beaten earnings estimates in three of the trailing four quarters, with an average surprise of 32.78% [12]

Company Performance - Shares of Biogen Inc have declined more than 50% in the past 18 months and are significantly below their 2015 peak of approximately $500 per share [5] Investment Focus - The Growth Stock Forum focuses on identifying great growth stocks with an emphasis on biotech and attractive risk/reward situations [2] - The forum features a model portfolio of 15-20 names updated regularly, a top picks list of up to 10 stocks expected to perform well in the current calendar year, and trading ideas targeting both short-term and medium-term moves [3]

Biogen Inc. (NASDAQ:BIIB) 7th Annual Evercore ISI HealthCONx Healthcare Conference Call December 3, 2024 9:10 AM ET Company Participants Alisha Alaimo - President and Head of North America Michael McDonnell - Chief Financial Officer Conference Call Participants Umer Raffat - Evercore ISI Umer Raffat Okay, thank you guys for joining us. Pleasure to have Biogen Management. Really looking forward to this conversation. Alisha, thank you for making time. I'll let you kick things off. Alisha Alaimo Thank you. I t ...

Biogen Inc. (NASDAQ:BIIB) 7th Annual Evercore ISI HealthCONx Healthcare Conference Call December 3, 2024 9:10 AM ET Company Participants Alisha Alaimo - President and Head of North America Michael McDonnell - Chief Financial Officer Conference Call Participants Umer Raffat - Evercore ISI Umer Raffat Okay, thank you guys for joining us. Pleasure to have Biogen Management. Really looking forward to this conversation. Alisha, thank you for making time. I'll let you kick things off. Alisha Alaimo Thank you. I t ...

Clinical Trial Results - Dapirolizumab pegol (DZP) met its primary endpoint, showing statistically and clinically significant improvement across all organ systems as measured by BICLA, with a 14.6% higher response rate (49.5%) compared to standard of care (SOC) alone (34.6%) [1][2] - Participants receiving DZP experienced 50% fewer severe disease flares compared to those on SOC alone [1] - At Week 24, DZP plus SOC showed a 7.9% higher BICLA response rate (46.6%) compared to SOC alone (38.3%), though the difference was not statistically significant [3] Secondary Endpoints and Clinical Improvements - 17.1% more participants receiving DZP reduced their corticosteroid dose from >7.5 mg/day to ≤7.5 mg/day at Week 48 (72.4% vs. 52.9%) [4] - DZP plus SOC showed an 18.8% higher SRI-4 response rate at Week 48 (60.1% vs. 41.1%) [4] - A 1.8-fold greater decrease in SLEDAI-2K was observed in the DZP group compared to SOC alone at Week 48 (-6.1 vs. -4.2) [4] - 20.9% more participants in the DZP group achieved Lupus Low Disease Activity State (LLDAS) at Week 48 (40.9% vs. 19.6%) [4] Safety Profile - The safety profile of DZP was generally favorable, with 82.6% of participants experiencing treatment-emergent adverse events (TEAEs) compared to 75.0% in the SOC group [6] - Serious TEAEs were reported in 9.9% of participants receiving DZP plus SOC compared to 14.8% in the SOC group [6] - Opportunistic infections were reported in 2.8% of participants receiving DZP plus SOC compared to 0.9% in the SOC group [6] Disease Background - Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease affecting multiple organ systems, primarily in women, with 90% of cases occurring in women aged 15-55 [9] - SLE is associated with a higher risk of death from infections and cardiovascular disease, and pregnancy in women with SLE carries higher maternal and fetal risks [9] Drug Mechanism and Development - Dapirolizumab pegol is a novel Fc-free anti-CD40L drug candidate that inhibits CD40L signaling, reducing B cell activation and autoantibody production [10] - The drug is currently in Phase 3 clinical development for SLE under a collaboration between UCB and Biogen [10] Company Information - UCB is a global biopharmaceutical company focused on severe diseases of the immune system and central nervous system, listed on Euronext Brussels [11] - Biogen is a leading biotechnology company pioneering innovative science to deliver new medicines, founded in 1978 [12]