In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
Statements Cytodyn Inc. made about the potential for its investigational monoclonal antibody, leronlimab, to treat COVID-19 continue to reverberate with U.S. authorities.
In a rare move, the FDA disclosed summary trial information May 17 about Cytodyn Inc.’s Vyrologix (leronlimab), noting that currently available data don’t support the clinical benefit of the drug as a COVID-19 treatment.
Shares of Paris-based Abivax SA (Paris:ABVX) fell 25.4% to €21 (US$25.07) on March 8 after the company said it would halt a phase IIb/III trial of its lead candidate, ABX-464, in high-risk COVID-19 patients for lack of efficacy. The decision was based on a data safety monitoring board analysis that Abivax said revealed a "lower than expected rate (10.1%) of progression to severe disease or death with no difference between ABX-464 and placebo groups," each of which also received standard-of-care therapy.