Phase II
Eliem Therapeutics could be in trouble following the announcement that its drug candidate ETX-810, intended to treat diabetic peripheral neuropathic pain, did not meet its primary endpoint.
Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.
It was yet another busy week for clinical trial news, with a range of studies for COVID-19, various cancers, fungal infections and other indications.
Faron Pharmaceuticals announced a new analysis that estimates 100% overall survival at 12-months for patients who experienced clinical benefit following treatment with bexmarilimab.
Clinical results announced this week could expand COVID-19 prevention options for the immunocompromised and vaccine ineligible, as well as those that have already contracted COVID.
Ultragenyx and Mereo celebrated their first patient dosed in a Phase II/III study investigating the use of setrusumab as a treatment for osteogenesis imperfecta (OI).
The FDA noted that the EUA application for Novavax’s COVID-19 shot may take a while to be resolved, citing an “incredibly complex review process.”
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
Biopharma and life sciences organizations from across the globe provide updates on their businesses and pipelines.
Arcturus Therapeutics announced positive Phase III trial results for its mRNA vaccine candidate, ARCT-154, intended to prevent COVID-19 caused by the SARS-CoV-2 virus.
PRESS RELEASES