Abivax Crashes Most On Record After Cancer Cases In Trial Data Spooks Wall Street
French biotech Abivax suffered its largest intraday decline on record after reporting new data on its lead experimental inflammatory bowel disease drug, which showed cancer cases among patients in the clinical trial. The new data certainly point to regulatory headwinds and raise the risk profile for approval. Abivax’s ABTECT maintenance data showed strong efficacy readout, with both once-daily obefazimod doses meeting the primary endpoint at week 44. Clinical remission rates were 50.8% for the 25 mg dose and 51.3% for the 50 mg dose, versus 10.4% for placebo, implying placebo-adjusted remission rates of about 39% to 40% and highly statistically significant results. The problem for the stock was not efficacy, but safety optics… Goldman analyst Esah Hayat pointed out that the market was focused not on efficacy but on cancer cases among patients taking the higher doses of obefazimod: ABTECT maintenance trial out yday (press release) – “at week 44, both the 25 mg and 50 mg once-daily obefazimod doses met the primary endpoint, demonstrating placebo-adjusted clinical remission rates of ∆39.3% and ∆40.3%, respectively (25 …






