Baris-Ozer COSCIENS Biopharma ( NASDAQ: CSCI ) fell ~31% on Tuesday after the Canadian biotech said its lead asset, macimorelin, failed to reach the main goal in a Phase 3 trial for the diagnosis of childhood-onset growth hormone deficiency (CGHD). Based on topline results from its DETECT trial, Cosciens ( CSCI ) said macimorelin didn't reach the study's primary efficacy endpoint compared to standard growth hormone stimulation tests. The company attributed the setback to a high false positive rate, noting that "these unexpected results require further clarification and some re-analyses to consider the trial outcome and the strategy moving forward.
" Macimorelin is already marketed in the U.S. and the EU for diagnosing adult growth hormone deficiency (AGHD), and the DETECT trial was an international study conducted for those aged three to 17 years as part of its pediatric investigation plan.
Safety data confirmed the oral drug's established tolerability profile, Cosciens ( CSCI ) said, adding that it plans to announce full trial results later this year. More on COSCIENS Biopharma Financial information for COSCIENS Biopharma.
