Phase II
The experts will assess unblinded data from BEACON-IPF to figure out why a data safety monitoring board recommended suspension of the idiopathic pulmonary fibrosis trial.
The data, published in JAMA Psychiatry, add to the growing body of evidence supporting the use of GLP-1 receptor agonists for addictive disorders.
Helmed by Roche alums, Newleos Therapeutics is taking over four drugs dropped from the Swiss pharma’s pipeline in early 2024.
The Boston-area company’s previous raises were also aimed at getting its investigational antibody treatment for inclusion body myositis through clinical trials. Now, Abcuro is eyeing a regulatory submission and potential launch.
Adding a new indication for the CAR T cell therapy could help BMS offset the loss-of-exclusivity headwinds it faces in the coming years.
It is unclear why an independent data safety monitoring board recommended the suspension of Pliant’s Phase IIb/III BEACON-IPF study in idiopathic pulmonary fibrosis.
AceLink is advancing a small-molecule treatment option for Fabry disease that could provide a more convenient alternative to the current enzyme replacement therapy standard.
In a mid-stage study, the candidate itolizumab achieved 23.3% clinical remission rate at 12 weeks, numerically better than Humira’s 20% at the same time point.
Kuro Oncology and partner Kyowa Kirin are on track for an NDA submission for ziftomenib in the second quarter of this year.
APAC offers stability in an increasing challenging global geopolitical environment for clinical stage drug development.
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