Biogen

Roche's Evrysdi leads SMA market with 16,000+ patients, growing 21% to $1.45B. Biogen's Spinraza faces 13% revenue decline to $1.15B, but sees growth potential. Novartis' Zolgensma grows 3% to $952M. Biogen explores higher-dose Spinraza, Roche considers combining Evrysdi with an anti-latent myostatin antibody.

Everest Medicines' EVER001, a next-gen BTK inhibitor for pMN, showed positive Phase 1b/2a results with 81.8% overall clinical remission in low-dose cohort and 85.7% in high-dose cohort. EVER001 offers improved selectivity and broad potential in autoimmune-driven glomerular diseases, positioning Everest as a leader in nephrology with global market potential.

GeneDx partners with Biogen, Praxis Precision Medicines, and Stoke Therapeutics to expand exome testing access for pediatric epilepsy patients, aiming to reduce the diagnostic odyssey and improve treatment outcomes.

Micaela F. Bayard, MD, discusses the inclusion of patient voices in rheumatoid arthritis clinical trials at ACR Convergence 2024, emphasizing the need for diversity and representation.

Big pharma's patent cliff presents a $200 billion opportunity for biosimilar developers, especially with biologics. Five companies—Alvotech, Biocon Biologics, Celltrion, Formycon, and Samsung Bioepis—are highlighted for their biosimilar developments and partnerships, aiming to capitalize on this market shift. The biosimilar market is projected to grow significantly, reaching $150.26 billion by 2033, driven by FDA regulations and demand for affordable treatments.

GeneDx announces Biogen, Praxis Precision Medicines, and Stoke Therapeutics as founding partners for its Patient Access Program for pediatric epilepsy, aiming to increase access to whole exome sequencing and improve genetic diagnosis rates.

Denali Therapeutics initiates global Phase 2a BEACON study of LRRK2 inhibitor BIIB122 for LRRK2-associated Parkinson's disease, evaluating safety and biomarkers in 50 participants with LRRK2 mutations. The study includes a three-month double-blind treatment period followed by an open-label extension, and BIIB122 is also being investigated in the ongoing Phase 2b LUMA study for early-stage Parkinson's disease patients with or without LRRK2 mutation, in collaboration with Biogen.

Eisai and Biogen announce COFEPRIS approval of LEQEMBI® (lecanemab) for early Alzheimer’s disease, targeting soluble and insoluble Aβ aggregates. LEQEMBI is the first treatment shown to reduce disease progression and cognitive decline, already approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, the UAE, and Great Britain. The approval is based on the Phase 3 Clarity AD study, which met primary and secondary endpoints with significant results.

BioArctic's partner Eisai announces COFEPRIS approval of Leqembi for early Alzheimer's disease in Mexico. Leqembi reduces Aβ protofibrils and plaques, slowing cognitive decline. It's also approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain. Based on Phase 3 Clarity AD trial data, Leqembi met primary and secondary endpoints. Collaboration with BioArctic began in 2005, with Eisai leading clinical development and commercialization.