Aeterna Zentaris doubles down on macimorelin PhIII, and loses
Two years after the FDA handed Aeterna Zentaris a stinging rejection for its proposal to market macimorelin for the evaluation of growth hormone deficiency in adults, the biotech says the drug flunked another late-stage study.
Just as Aeterna Zentaris witnessed in late 2014, its stock $AEZS cratered, dropping by about 50% in after-market trading.
The FDA sent Aeterna Zentaris back to the clinical drawing board after pointing out that macimorelin had failed to hit the primary endpoint. Aeterna Zentaris moved from Canada down to Charleston, SC more than two years ago, promising to create 60 jobs.
There’s no immediate word on next steps at the biotech for this two-time failure, but CEO David Dodd has a backup plan. In a statement, he said:
While we are disappointed regarding the outcome of this trial, we will now re-direct our resources to the completion of the on-going Phase 3 clinical trial of Zoptrex in women with advanced, recurrent or metastatic endometrial cancer who have progressed and who have received one chemotherapeutic regimen with platinum and taxane (either as adjuvant or first-line treatment).