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ChemoCentryx, Inc.

https://www.chemocentryx.com/

Latest From ChemoCentryx, Inc.

ChemoCentryx’s Avacopan May Need Another Trial After Tepid Advisory Committee Vote

Near tie goes to the US FDA? While almost every member of the Arthritis Advisory Committee agreed with agency’s assessment that ChemoCentryx’s trial of avacopan for ANCA vasculitis was poorly designed, making it hard to tease out the drug’s benefit-risk profile, about half were in favor of approval due to the potential to spare patients from the adverse effects of steroids. Others said the sponsor didn’t meet the agency’s standard for approval off just one pivotal study.

Advisory Committees Rare Diseases

Finance Watch: Dyno Therapeutics Raises $100m For Novel AAV Vectors

Private Company Edition: Dyno’s first VC round will enable more deals for its novel AAV platform; Eikon pioneers new drug discovery technology. Also, Treeline’s early funding revealed at $211.7m; Capsida raised $140m from a VC round, AbbVie deal; and Affinia closed a $110m series B round. 

Financing Innovation

Failure to Heed FDA Warnings of Poor Trial Design Likely To Haunt ChemoCentryx At Advisory Cmte.

Phase III trial was statistically significant, but US FDA argues complex study design makes it unclear that ChemoCentryx’s avacopan offers a clinically meaningful benefit, including a safety advantage, for ANCA vasculitis. Agency had tried to direct company to better designed trials earlier in development program.

Advisory Committees Drug Approval Standards

Adverum Halts Phase II Gene Therapy Trial After Patient’s Vision Loss

Slated to begin a Phase III later this year of ADVM-022 in wet AMD, Adverum had to scuttle a Phase II study of the gene therapy in DME after a patient suffered ocular hypotension, panuveitis and vision loss in the treated eye.

Clinical Trials Drug Safety
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