Phase II

After overcoming a clinical hold, Astellas presented preliminary safety and efficacy data from the Phase I/II FORTIS trial of AT845 in late-onset Pompe disease at the 19th Annual WORLDSymposium 2023.
One-year data from a Phase II study of Newron’s schizophrenia candidate evenamide showed sustained efficacy and continued improvements in symptoms of psychosis and disease severity.
Seagen did not address rumors of a buyout from Merck during its fourth-quarter and full-year financial report. Instead, it focused on upcoming label expansions and its promising pipeline.
Talaris Therapeutics is cutting one-third of its workforce and dropping two clinical trials studying its lead candidate.
The FDA has rejected Soligenix’s NDA for HyBryte (synthetic hypericin), a therapeutic developed to treat early-stage cutaneous T-cell lymphoma.
Clene, Inc. posted new data from a Phase II trial of CNM-AU8 in multiple sclerosis featuring MRI results it claims reinforce neurological improvements reported in November 2022.
Due to safety concerns, Aristea Therapeutics announced Friday that it was discontinuing the development of its Phase II lead program. As a result, the San Diego-based biotech is also dissolving its business.
Merck and Nectin Therapeutics announced a research collaboration agreement to study the safety and efficacy of Nectin’s investigational antibody in locally advanced and metastatic solid tumors.
Industry leaders say the second generation of interventions for nonalcoholic steatohepatitis is likely to succeed where first-generation approaches stumbled.
Janssen reported positive topline data from a Phase II proof of concept study assessing nipocalimab in severe hemolytic disease of the fetus and newborn.
PRESS RELEASES