Once every four weeks maintenance dosing may be easier for patients and care partners to continue treatment Alzheimer's disease progression does not stop after plaque clearance; ongoing treatment with LEQEMBI can slow disease progression and prolong the benefits of therapy TOKYO and CAMBRIDGE, Mass., Jan. 26, 2025 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbache ...

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. (NASDAQ:BIIB) J.P. Morgan 43rd Annual Healthcare Conference January 14, 2025 12:45 PM ET Company Participants Chris Viehbacher - President and CEO Conference Call Participants Chris Schott - JPMorgan Chris Schott I think we are ready to kick off the next session here. So good morning, everybody. I'm Chris Schott from JPMorgan, and I'm pleased to be introducing Biogen today. From the company, we have Chris Viehbacher, the company's President and CEO. Chris has been CEO for a little bit over 2 yea ...

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 ...