Biogen Inc. CEO Chris Viehbacher views Novo Nordisk's potential success in using its weight-loss drug for Alzheimer's disease as an opportunity rather than a roadblock. He suggests combining Alzheimer's and obesity drugs could lead to more effective therapies, though timelines remain uncertain due to the lengthy nature of Alzheimer's drug development. Biogen is leveraging its Alzheimer's drug Leqembi to offset declining sales in its multiple sclerosis franchise, which faces competition from cheaper generics. Leqembi is a joint venture between Biogen and Eisai Co. Biogen produces the active ingredient in Switzerland and manufactures the final product in North Carolina. The company plans to invest an additional $2 billion in its North Carolina manufacturing facilities in Research Triangle Park, a move not directly tied to recent U.S. tariffs on Swiss imports. Novo Nordisk is conducting clinical trials on its diabetes and weight-loss drugs Ozempic and Wegovy for early Alzheimer's, with results expected later this year. Experts remain skeptical about the drug's effectiveness in improving cognitive outcomes.

Denali Therapeutics reported a second-quarter 2025 loss of 72 cents per share, narrower than the Zacks Consensus Estimate of 74 cents, with a year-ago loss of 59 cents per share. The loss increased year over year due to higher operating expenses, primarily research and development and general and administrative costs. The company has no marketed products and generates no collaboration revenues in the reported quarter. Denali announced in July 2025 that the FDA accepted its biologics license application (BLA) for tividenofusp alfa for priority review with a target action date of January 5, 2026. The drug is an investigational enzyme replacement therapy designed to cross the blood-brain barrier for treating Hunter syndrome. Denali is also advancing DNL126 for Sanfilippo syndrome type A, with the FDA suggesting cerebrospinal fluid heparan sulfate as a surrogate endpoint. The company is preparing for a global phase III study and has a collaboration with Takeda on DNL593 for frontotemporal dementia. Denali and Biogen are jointly evaluating BIIB122/DNL151 for Parkinson’s disease, with Biogen leading the phase IIb LUMA study and Denali conducting the phase IIa BEACON study. Denali expects to submit regulatory applications for one to two TV-enabled programs annually over the next three years across its Enzyme TV, Antibody TV, and Oligonucleotide TV franchises, including candidates for Pompe disease, Parkinson’s, Gaucher disease, and Alzheimer’s disease.

Denali Therapeutics, a biopharmaceutical company based in South San Francisco, has released its Q2 2025 earnings, reporting a net loss of $124.1 million due to increased research and development expenses. The company has received FDA priority review for tividenofusp alfa in treating Hunter syndrome with a target action date of early 2026 and is pursuing an accelerated approval path for its DNL126 program targeting Sanfilippo syndrome Type A. Denali is also advancing collaborations with Takeda and Biogen for treatments in frontotemporal dementia and Parkinson’s disease, respectively. The company maintains $977.4 million in cash and marketable securities as of June 30, 2025, and plans to submit regulatory applications for additional Transport Vehicle-enabled therapies in 2025.

The Galien Foundation announced the 2025 Prix Galien USA nominees for three categories: Best Biotechnology Product, Best Pharmaceutical Product, and Best Product for Rare/Orphan Diseases. Winners will be revealed at an awards ceremony in New York City on October 30, 2025. The nominees include products from major pharmaceutical and biotechnology companies, with the Awards Committee comprising notable figures from academia and industry.

Denali Therapeutics Inc. reported its second quarter 2025 financial results, noting a net loss of $124.1 million, up from $99.0 million in the same period of 2024. The company announced that the U.S. FDA accepted its Biologics License Application (BLA) for tividenofusp alfa in treating Hunter syndrome for priority review with a PDUFA target date of January 5, 2026. The drug, an enzyme replacement therapy designed to cross the blood-brain barrier, previously received Breakthrough Therapy, Fast Track, Orphan Drug, and Rare Pediatric Disease designations. Denali also reached alignment with the FDA on using cerebrospinal fluid heparan sulfate as a surrogate endpoint for Sanfilippo syndrome Type A, with ongoing Phase 1/2 data showing significant reduction in CSF HS and a favorable safety profile. The company continues Phase 2/3 COMPASS study and is planning a global Phase 3 trial. Denali is co-developing LRRK2 inhibitors with Biogen for Parkinson’s disease, with Biogen’s Phase 2b LUMA study completing enrollment and a readout expected in 2026. Denali is also conducting its Phase 2a BEACON study. The company plans to submit regulatory applications for one to two Transport Vehicle (TV)-enabled programs annually over the next three years, including candidates for Pompe disease, Parkinson’s, Gaucher disease, MPS I, Alzheimer’s, and frontotemporal dementia. Preclinical data on ATV:Abeta was published in Science, showing improved brain delivery and reduced ARIA risk in a mouse model of Alzheimer’s. Denali is based in South San Francisco and is developing therapies to treat neurodegenerative and lysosomal storage diseases.