tldrdailynews.com logo
Tag

Biogen

All articles tagged with #biogen

Biogen defends tau-targeting drug as phase 2 data pave way for pivotal trial
business1 month ago

Biogen defends tau-targeting drug as phase 2 data pave way for pivotal trial

Biogen defended the phase 2 Celia readout of diranersen, an antisense drug that lowers brain tau and slowed cognitive decline, noting the 60 mg dose gave the strongest clinical signal and fewer post-infusion confusions, justifying a rapid move to a phase 3. While the data did not show a clear dose-dependent response, the results—presented at AAIC in London—are viewed as proof-of-concept for tau targeting and could complement anti-amyloid therapies. Investors reacted with optimism as the stock recovered after an initial slide.

via Fierce Biotech|
#alzheimers-disease#biogen#business
business2 months ago

Biogen to Acquire RayThera for Up to $1B to Strengthen Immunology Pipeline

Biogen announced a definitive agreement to acquire RayThera Inc. for up to $1 billion, adding multiple small-molecule immunology assets including a lead candidate set to enter Phase 1 in early Q3 2026. Biogen will lead development, manufacturing and global commercialization after closing, which is anticipated in Q3 2026, with an upfront payment and milestone payments contingent on clinical/regulatory milestones, subject to customary closing conditions and regulatory approvals.

via Biogen|
#acquisition#biogen#business
Biogen and Denali end LRRK2 Parkinson’s program after phase 2b setback
business3 months ago

Biogen and Denali end LRRK2 Parkinson’s program after phase 2b setback

Biogen and Denali terminated BIIB122 (DNL151), a LRRK2 inhibitor for idiopathic Parkinson’s, after a phase 2b trial failed to meet its primary endpoint despite strong target engagement (about 90% peripheral LRRK2 inhibition and a ~30% CSF biomarker decrease). The decision ends the idiopathic program, though Denali will continue a phase 2a trial in LRRK2-associated Parkinson’s, and the deal’s upfront cost ($400 million in 2020) and earlier phase 3 cutbacks underscore the challenge of translating target activity into clinical benefit in Parkinson’s disease.

via Fierce Biotech|
#biib122-dnl151#biogen#business
business3 months ago

Biogen closes Apellis deal, pairing two marketed drugs with a nephrology-focused expansion

Biogen completed its all-cash acquisition of Apellis Pharmaceuticals, making Apellis a wholly owned subsidiary and adding the marketed therapies EMPAVELI and SYFOVRE to Biogen’s portfolio, which together generated $689 million in net product revenue in 2025. The deal was financed via a tender offer at $41 per share plus a contingent value right, with about 82% of Apellis shares tendered. Biogen expects the acquisition to be accretive to non-GAAP diluted EPS in 2027 and to enhance long-term growth through nephrology expansion, including felzartamab’s first Phase 3 readout for antibody-mediated rejection in kidney transplant patients in 2027. Updated guidance will be provided with Biogen’s Q2 earnings in July.

via Biogen|
#acquisition#apellis#biogen
business4 months ago

Biogen to Acquire Apellis, Expanding Immunology and Nephrology Footprint

Biogen will acquire Apellis for $41 per share in cash (about $5.6 billion) plus a contingent value right tied to SYFOVRE’s sales, adding two approved medicines—EMPAVELI and SYFOVRE—to Biogen’s growth portfolio and accelerating Biogen’s nephrology plans with Apellis’ team; 2025 combined net product revenue for EMPAVELI and SYFOVRE was $689 million and is expected to grow mid-to-high teens through 2028. Closing is anticipated in Q2 2026, financed by cash and borrowings with plans to de-leverage by 2027. Apellis’ US sales capabilities and nephrology expertise will bolster Biogen’s readiness for felzartamab in Phase 3, while Sobi retains EMPAVELI rights outside the U.S.; the CVR pays up to two $2-per-share amounts based on SYFOVRE sales thresholds and a possible $4-per-share payment in 2031 if higher sales are reached.

via Biogen|
#apellis#biogen#business
European Committee Reverses Stance, Approves Alzheimer's Drug
health1 year ago

European Committee Reverses Stance, Approves Alzheimer's Drug

The European Medicines Agency's Committee for Medicinal Products for Human Use has reversed its earlier decision and now recommends approval of the Alzheimer's drug lecanemab, known as Leqembi in the U.S., for early-stage treatment. This comes after initial concerns about side effects like brain swelling and bleeding. Developed by Eisai and co-marketed with Biogen, the drug has shown to slow cognitive decline in Alzheimer's patients. The European Commission is expected to make a final decision on marketing authorization soon.

via Yahoo Finance|
#alzheimers#biogen#drug-approval
"FDA Advisory Committee Reviewing Alzheimer's Therapy Donanemab Amid Approval Delays and Treatment Battle"
health2 years ago

"FDA Advisory Committee Reviewing Alzheimer's Therapy Donanemab Amid Approval Delays and Treatment Battle"

Eli Lilly's Alzheimer's treatment, donanemab, faces setbacks as the FDA delays its approval decision and plans to hold an advisory committee meeting to discuss the drug. Competitors like Biogen and Roche are also making strides in Alzheimer's treatments, with a focus on under-the-skin shots and precision medicine. Despite the setbacks, experts believe it's an exciting time in the fight against Alzheimer's disease, with unprecedented diversity in Phase 3 clinical trials offering hope for more treatment options. However, challenges remain, including safety concerns and the need for more personalized approaches to treatment.

via Investor's Business Daily|
#alzheimers#biogen#eli-lilly
"Biogen Shifts Focus Away from Aduhelm, Explores Alternative Alzheimer's Treatments"
health-pharmaceuticals2 years ago

"Biogen Shifts Focus Away from Aduhelm, Explores Alternative Alzheimer's Treatments"

Biogen is discontinuing its controversial Alzheimer's drug Aduhelm to focus on other treatments, including its blockbuster drug Leqembi, which was developed with Japan's Eisai and approved in 2023. The decision comes after concerns about the risks of Aduhelm outweighing its benefits, leading Medicare to significantly limit coverage of the drug. Despite discontinuing Aduhelm, Biogen aims to build a leading franchise addressing the multiple pathologies of Alzheimer's disease and patient needs.

via Fox Business|
#aduhelm#alzheimers#biogen
"Biogen Pulls Aduhelm: Shifting Focus to Experimental Alzheimer's Treatments"
health-pharmaceuticals2 years ago

"Biogen Pulls Aduhelm: Shifting Focus to Experimental Alzheimer's Treatments"

Biogen has withdrawn its controversial Alzheimer's drug, Aduhelm, from the market following criticism and irregularities in the approval process by the US FDA. The drug's accelerated approval was highly contentious, and its high price of $56,000 a year for patients was deemed unjustifiably high. Biogen will focus on its newer Alzheimer's medicine, Leqembi, which was fully approved last year. Alzheimer's is the most common form of dementia, affecting more than one in nine people over 65.

via ScienceAlert|
#aduhelm#alzheimers#biogen
"Biogen Ditches Aduhelm, Shifts Focus to Experimental Treatments"
business2 years ago

"Biogen Ditches Aduhelm, Shifts Focus to Experimental Treatments"

Biogen has decided to relinquish its ownership rights to the controversial Alzheimer's drug Aduhelm and halt a clinical trial aimed at confirming its effectiveness. The drug, initially priced at $56,000 a year, faced criticism for its approval based on weak evidence and serious safety risks. Biogen's move comes after Aduhelm failed in the marketplace, generating outrage and eroding trust in the regulatory process. The rights to Aduhelm will return to the Swiss company Neurimmune, and Biogen will cease supplying the drug in the United States by November.

via The New York Times|
#aduhelm#alzheimers#biogen
"Biogen Halts Production of Aduhelm, Shifts Focus to Experimental Treatments"
health2 years ago

"Biogen Halts Production of Aduhelm, Shifts Focus to Experimental Treatments"

Biogen announced it will discontinue the development and marketing of Aduhelm, a controversial Alzheimer's drug that received accelerated approval from the FDA in 2021. The decision comes after an internal review led the company to redirect its resources toward other drug candidates and advancing Leqembi, another Alzheimer’s drug it’s marketing with Eisai. The clinical trials for Aduhelm and Leqembi showed modest benefits for patients and potentially dangerous side effects, leading to limited Medicare coverage for Alzheimer’s drugs with accelerated approval.

via POLITICO|
#aduhelm#alzheimers-disease#biogen
"Biogen's Decision to Discontinue Aduhelm: Impact on Alzheimer's Treatment"
health-pharmaceuticals2 years ago

"Biogen's Decision to Discontinue Aduhelm: Impact on Alzheimer's Treatment"

Biogen will discontinue the sale of its Alzheimer's drug Aduhelm and halt the study needed for full FDA approval, shifting focus to other treatments. The drug, initially anticipated to be a blockbuster, faced challenges with limited evidence of efficacy and insurance coverage restrictions. Biogen will support the sale of another Alzheimer's treatment, Leqembi, which received full FDA approval. The company will incur a charge of about $60 million for shutting down the Aduhelm program, while patients may soon have another treatment option pending FDA review of a potential drug from Eli Lilly and Co.

via The Associated Press|
#aduhelm#alzheimers#biogen