Neurodegenerative disease
Passage Bio, which has been working toward a registrational trial for a drug candidate whose indications include frontotemporal dementia, is exploring strategic alternatives in addition to cutting staff.
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
Corcept Therapeutics’ amyotrophic lateral sclerosis drug was linked to an 87% reduction in the risk of death, a result the biotech hopes to replicate in an upcoming Phase 3 trial.
Over the last two years, Alector has suffered three setbacks for its neurodegenerative disease pipeline, often forcing the company to downsize.
Key dosing differences between Eli Lilly’s Kisunla and Biogen’s Leqembi are about to come to a head in the Alzheimer’s market as patients end their 18-month course of Lilly’s product.
The pivotal study of zilganersen in Alexander disease missed a secondary endpoint, but analysts expect the FDA to approve the asset given the unmet need and overall data.
Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer’s disease, was previously discontinued after an FDA hold and disappointing early data.
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
At the AD/PD annual meeting, Eisai presented real-world data suggesting Leqembi’s long-term safety and efficacy in people homozygous for APOE4, who were identified in trials as being at higher risk of brain bleeds while on the treatment. Alzheon, meanwhile, added further detail to trial results of its candidate in patients with the same genetic profile.
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