STAT+: Pharmalittle: We’re reading about a setback for Argenx, Lilly suits over copycat versions of an obesity drug, and more
The FDA flagged a potential safety signal after four patient deaths in a trial testing a schizophrenia drug, Argenx faces an unusual setback, and more pharma news.
Argenx shares an unfortunate development as its prominent drug Vyvgart falls short in a Phase 3 trial for Sjögren's disease, STAT reports. This unexpected setback leaves Argenx, a leading biotech in autoimmune disorders, pondering its market cap. William Blair analysts had forecasted peak sales of $1.4 billion from Vyvgart, but warned of the high risk due to patients' propensity for strong placebo responses.
The trial was prematurely halted early this year after a data monitoring committee found the primary endpoint unattainable. The Food and Drug Administration (FDA) raised concerns regarding a potential safety signal involving the investigational drug evenamide, which caused four deaths in patients with treatment-resistant schizophrenia during clinical trials.
The FDA halted enrollment in a Phase 3 trial for Newron Pharmaceuticals' medicine following a participant's sudden death; the restriction persists in U.S. study centers, while enrollment continues internationally and more clinical sites are being added.
Written by urgent.news from STAT News's reporting — not their text. Machine-written — may contain errors; check the original before relying on it.
